summary of apsmi country report 2019 · medication in apsmi member countries; i.e. china, chinese...

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Summary of APSMI Country Report 2019

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Contents

Introduction…………………………………………………………………………… 2 I. Summary of OTC Regulation in Member Countries………………………. 3 II. Activities to Promote Self-Medication by Member Associations…………11 III. OTC Market in Asia-Pacific Region…………………………………………..23 Annex 1: Dossier Requirements for OTC Registration Annex 2: Rx-to-OTC Switch Products in Member Countries Annex 3: New and Amended Regulation from 2016 to 2019 in Member Countries

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Introduction Thanks to the contributions by its member associations and magnanimous provision of the market analysis by Nicholas Hall, Asia-Pacific Self-Medication Industry (APSMI) compiled the APSMI Country Report 2019 in October 2019. The Report was published on the occasion of the 12th Global Self-Care Federation Asia-Pacific Regional Conference & 4th APSMI General Assembly held in Beijing, October 2019, made available to the meeting participants and the APSMI members. The Report outlines the OTC regulations and the activities to promote self-medication in APSMI member countries; i.e. China, Chinese Taipei, Indonesia, Japan, Korea, and Thailand. It also includes analyses of global and Asian OTC markets as well national markets in the region. Though the access to the full Report remains to be the members’ privilege, APSMI has decided to publish its summary to the open public. The APSMI sincerely hopes that the information contained in the Summary Report will contribute to the OTC market growth, harmonization of OTC regulation, and promoting self-medication in the region. APSMI Secretariat November 2019

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I. Summary of OTC regulations in member countries

-Notes – The description of each country is simplified for the ease of comparison.

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1. Category of drugs (OTC and Prescription and others?) China OTC and Rx. Herbal medicines are classified into OTC or Rx.

OTCs are subcategorized with regard to allowable sales route. Some are general sales line items.

Chinese Taipei

OTC, RX and Traditional Chinese Drugs. OTCs are subcategorized into Pharmacy-only and general sales drugs.

Indonesia OTC and Rx. Herbal medicines form another category different from OTC or Rx. OTCs are subcategorized with regard to allowable sales route. Some are general sales line items.

Japan OTC and Rx. Herbal medicines are classified into OTC or Rx. OTCs are subcategorized with regard to allowable sales route.

Korea OTC and Rx. Except for little exception, OTCs are sold only at pharmacies.

Philippines OTC and Rx. Herbal medicines form another category. OTCs are sold only at pharmacies.

Thailand Rx, Modern OTC, and Traditional OTC. OTCs are subcategorized into drug store-only and general sales drugs.

2. Abridged approval applications (for e.g. OTC with precedents, monograph-

compatible OTCs, etc.) China Full application only. There is no difference in required data

between Rx and OTC. Chinese Taipei

Abbreviated applications for switch OTC and monographs-compatible OTCs

Indonesia Abbreviated applications for drugs with precedents. Japan Abbreviated applications for switch OTC and monographs-

compatible OTCs Korea Abbreviated applications for switch OTC and monographs-

compatible OTCs Philippines Abbreviated applications for switch OTC and monographs-

compatible OTCs Thailand No abbreviated application for OTC. OTC applications follow the

guidelines for new drugs or generic drugs. 3. Review track /Review department specially for OTCs

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China The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs.

Chinese Taipei

The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs.

Indonesia The authority has specially designated review track and review department for OTC.

Japan The authority has specially designated review track and review department for OTC.

Korea The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs.

Philippines The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs.

Thailand The authority has no specially designated review track or review department for OTC. Approval application for OTC is reviewed not differently from new drugs.

4. Regulatory permission on Advertisement of OTC to the general public

China Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials).

Chinese Taipei

Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials).

Indonesia Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials).

Japan No regulatory permission is needed. But the Japanese OTC industry has self-imposed guideline on advertisement as well as a committee to survey member companies’ advertisements as to their adherence to the guidelines and to recommend rectification when there are any violations.

Korea Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials).

Philippines Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials).

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Thailand Need of regulatory permission for advertisement in all media (TV, Radio, Internet, Printed materials).

5. Regulatory permission on revising labelling of OTCs

China Necessary Chinese Taipei

Necessary

Indonesia Necessary Japan Necessary, but only for the essential part on the drug’s

indication, dosage, and caution on use. Other parts to provide information of more promotional nature can be revised without permission.

Korea Necessary Philippines Necessary Thailand Necessary

6. Standards and Guidelines applicable to OTC drugs

(1) GMP China GMP applied to OTC is aligned to PIC/S GMP Chinese Taipei

GMP applied to OTC is aligned to PIC/S GMP

Indonesia GMP applied to OTC is aligned to PIC/S GMP Japan GMP applied to OTC is aligned to PIC/S GMP Korea GMP applied to OTC is aligned to PIC/S GMP Philippines GMP applied to OTC is aligned to PIC/S GMP Thailand GMP applied to OTC is aligned to PIC/S GMP

(2) Pharmacopoeia China The authority applies its domestic pharmacopoeia to OTC. Other

countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees.

Chinese Taipei

The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees.

Indonesia The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees.

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Japan The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees.

Korea The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees.

Philippines The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees.

Thailand The authority applies its domestic pharmacopoeia to OTC. Other countries’ pharmacopoeia e.g. USP, EP) are also used as reference to varying degrees.

(3) ICH guidelines applicability

i. Q1, 3, 6, 7

China Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC.

Chinese Taipei

Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC.

Indonesia Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC.

Japan All ICH Q Guidelines are applicable to RX and direct OTC (new chemical entity approved first as OTC). Other OTC are exempted from application of ICH guidelines but subject to simpler domestic guidelines.

Korea Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC.

Philippines Basic ICH Q Guidelines (Q1, Q3, Q6, and Q7) are generally applicable to both Rx and OTC.

Thailand Relevant ASEAN guidelines apply. ICH Guidelines are used as reference.

Q1 : Stability Q3: Impurities Q6 : Specifications Q7 : GMP for Active Pharmaceutical Ingredients

ii. S4 (Chronic Toxicity Testing)

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China S4 Guideline is applicable to both Rx and OTC. Chinese Taipei

S4 Guideline is applicable to OTC that is new drugs (direct OTC).

Indonesia S4 Guideline is not applicable to OTC. Japan All ICH S Guidelines are applicable to RX and direct OTC (new

chemical entity approved first as OTC). Other OTC are exempted from application of ICH guidelines but subject to simpler domestic guidelines.

Korea S4 Guideline is applicable to OTC. Philippines S4 Guideline is applicable to OTC. Thailand S4 Guideline is applicable to OTC.

iii. E2B, E2D, E6

China E2B, E2D, E6 are all applicable to Rx and OTC. Regarding ADR reporting, OTC and Rx undergo the same regulation.

Chinese Taipei

E2B, E2D, E6 are all applicable to Rx and OTC. Regarding ADR reporting, OTC and Rx undergo the same regulation.

Indonesia E2D and E6 are all applicable to OTC. Japan E2B, E2D, E6 are all applicable to Rx and OTC. Regarding ADR

reporting, OTC and Rx undergo the same regulation. Korea E2B, E2D, E6 are all applicable to Rx and OTC. E2B is partly

applicable. Philippines E2B, E2D, E6 are all applicable to Rx and OTC. Thailand E6 Applies to OTC. E2B and E2D are not implemented in

Thailand (for Rx or OTC). E2B : Individual Case Safety Reports E2D : Standards for Expedited Reporting E6 : Good Clinical Practice

iv. M1 and M4 China Pilot of M1 and China CTD (similar to M4) are implemented. Chinese Taipei

M1 and M4 are applicable to OTC.

Indonesia M1 and M4 are applicable to OTC. Japan M1 is applicable to both Rx and OTC. M4 is applicable to direct

OTC. Other types of OTC are exempted from M4 application. Korea M1 is being applied to OTC in stages. M4 is not applicable to

OTC. Philippines M1 is not applicable to OTC. M4 is applicable to OTC.

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Thailand M1 and M4 are not applicable to OTC. M4 is applicable only to new drugs.

M1 : MedDRA - Medical Dictionary for Regulatory Activities M4 : Common Technical Document

7. Rx-to-OTC Switch

China The process starts when applicants make applications for manufacturing OTC version of a Rx. The authority has an OTC switch guideline, with which to judge switch-ability.

Chinese Taipei

The process starts when applicants make applications for manufacturing OTC version of a Rx. The authority publishes the checklist of required documents as well as review principles. The assessment is made by an advisory committee.

Indonesia There is no switching scheme. Japan There is an official scheme to promote switching. An advisory

committee to the Ministry of Health Labor and Welfare assesses Rx ingredients for switch-ability based on requests from the public. If judged appropriate, the ingredients are recommended for switching to the Minister. Based on the publicized recommendation, any applicants make approval applications for the recommended ingredients.

Korea The process starts when applicants make applications for manufacturing OTC version of a Rx. The authority publishes an OTC switch guideline, with which to judge switch-ability.

Philippines The authority publishes the conditions and requirements regarding switch. But there has been no Rx-to-OTC switch.

Thailand The process starts when applicants make applications for manufacturing OTC version of a Rx. The authority defines clear criteria of switching as well as a guideline for Patient Information Leaflet user study. The assessment is made by an advisory committee taking the result of public hearing into consideration.

8. Drug Master File (DMF)

China DMF for active pharmaceutical ingredients (API). is mandated for OTC

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Chinese Taipei

DMF and API GMP certificate are mandatory for OTC.

Indonesia DMF is applicable for API in new product OTC. Japan DMF is not applicable for OTC. Korea DMF for API are mandated for some OTC Philippines DMF is not applicable for OTC. Thailand DMF is not mandated for OTC.

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II. Activities to promote Self-Medication by member

Associations

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1. China 1. Research and studies conducted by the member organization or in which

the member organization has been involved in:

On-going researches carried on for the following topics

1) Twin spans products (RX/OTC) management topic research

2) Non-prescription drug registration regulation research

2. Publications by organization or publications in which the organization was involved (please list the number of copies published, the target readers as specifically as possible)

"China Non-Prescription Drugs Industry Development Blue Book 2018" will be published in 2019. The blue book is target to related regulatory agencies, industry and the media. Over 2,000 copies were provided to the industries and to the general public via a publishing agency.

3. Events for promotion of self-medication, hosted by the organization or in which the organization was involved

2017/2018/2019 International Self-Care Day promotion activities and events supported by CNMA.

4. Advertising activities utilizing media, in which the organization was involved

1) Through the mass media to promote “International Self-Care Day".

2) Through the mass media to launch the activity of OTC Brand promotion month in 2018 and 2019.

5. Utilization of organization website

CNMA’s website included more information on OTC formulation and members activities.

6. Activities for government and regulatory authorities, lobbying activities

Continue to be involved in many government research activities on OTC regulations.

7. Joint activities with other organizations

NA

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2. Chinese Taipei 1. Events for promotion of Self-Medication, hosted by association or in which

the association is involved

TPMMA hold several events to establish the plate form for OTC industry to share information and learning, including:

1) OTC Brand Marketing Forum: to share the marketing best practice from leading brands to the industry and highlight the importance of a brand image.

2) OTC Stakeholders Summit (Experience from Japan): speakers from Dentsu (pharmaceutical market overview), Santen (new entry to Taiwan market from brand point of view), Matsumotokiyoshi Drug Store (opportunity in Taiwan from channel point of view) and AC Nielson (OTC market overview) to share the view and opportunity in Taiwan.

2. Activities for Government and Health Authority, lobby activities

1) OTC Task Force (composed by regulators, academics, pharmacists and industry representatives) was working with TFDA to update and expand the OTC monograph from 10 categories to 16 categories.

Expanding the dermatological category in to 7 sub-categories, including anti-fungal, anti-biotic & disinfectant, antipruritic & anti-inflammatory, anti-acne, diaper rash and dry skin.

2) Simplified DMF requirement for OTC registration: to exempt full dossier of DMF for OTC registration and only requires basic CMC documents.

3) Guidance for switch application (1st applicant): in order to encourage industry to apply for switch application, TFDA published a reference guidance (Rx-to-Pharmacy only) to outline basic requirements for switch application. In which, in addition to the overview of approval status in major countries, it requires the “Training materials to Pharmacists” for such application which is important to support the consultation to the pharmacists once the product is switched from Rx-to-OTC.

An example of “pharmacist training” was established by TFDA and published in TFDA website.

4) TFDA announced Refuse to File (RTF) for new drug and accepted to exclude OTC New Drug from this requirement. In addition, industry submitted the proposal for “simplified requirements for OTC New Drug registration” and pending TFDA consideration.

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5) Worked with Rx group to exempt the legalization requirements for:

- API GMP (original copy) issued by 10 major countries

- CoPPs issued by 10 major countries

3. Promotion of Self-medication with other associations _ International Network

1) Japan―Taiwan Workshop on the Regulation of OTC Medicine (OTC workshop) hold in December 2017 to exchange experience on OTC policy and regulatory requirements between Taiwan and Japan.

2) 6th Japan-Taiwan Joint Symposium (OTC section): to discuss the advertisement challenge in Taiwan (Oct 2018)

3) Support APSMI to host the 4th Self-CARER meeting in Taipei (March 2018)

This meeting included a pilot training programme _ Self-CARER university (supported by TSMIA), closed part and open part. There were

32 regulators from 10 health authorities attended the meeting. Key topics were focus on “promotion of self-medication”, “switch” and “increase efficiency on registration/review process”.

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3. Indonesia 1. The Smart Community Movement Program On Drugs Usage (GEMA

CERMAT)

A joint effort between the government and the community through a series of activities in order to create awareness, well understanding and community skills in using drugs appropriately and correctly.

This movement aims to increase public understanding and awareness about the importance of using drugs properly, increasing independence and changing people's behavior in choosing and using drugs correctly, and ultimately will increase the rationality use of drugs.

2. Promotion of : “Let's Live Healthy, It Starts with Us”

The national movement initiated by the President of the Republic of Indonesia announced in the context of strengthening health development which puts forward promotive-preventive efforts as first priority, without ruling out rehabilitative and curative efforts by involving all components of the nation in promoting paradigm of healthy with support from pharmaceutical industry.

3. Guidelines on the Use of OTC

Guidelines on the Use of OTC is compiled to assist the public in conducting self medication. The purpose of this guideline is to guide people who wants to do self medication and Pharmacists as guideline to help communities in self medication.

4. Promotion of Self Medication at Communities and Pharmacies

Education Care Of Medicine And Food Safety from National Agency of Drug and Food Control (NADFC), National movement to correctly GET, USE, SAVE, DISPOSE drugs.

The first is GET, which means getting the medicine in the right place, so that its benefits, safety and quality are guaranteed. The right place means that there is legality, for example a pharmacy, hospital, licensed drug store, clinical pharmacy.

Second, USE means to use drugs in accordance with the indications diagnosis of disease), according to the dosage, according to the rules of use, and according to the way of administration.

Third, SAVE, i.e. store medicine as written on the package, except if it has to be stored in special condition. Generally the drug is stored in a cool place (15-25 ° C), not exposed to direct sunlight, not in a humid place, and keep out of reach of children.

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Fourth is DISPOSE. Disposing of drugs must also be with the correct procedure. Drugs that are damaged or expired must be removed immediately, so that they can no longer be used. Disposal of over-the-counter drugs (green circle logo), limited over-the-counter drugs (blue circle logo) and prescription drugs (letter K with red circles) can be done by the communities themselves. In order not to be abused by other parties, the drug should be disposed of in a certain way so that it is completely out of shape.

5. Switch Rx to OTC Climate

Switch will be done by Ministry of Health under the recommendation of National Agency of Drug and Food Control (NADFC)

6. Healthy Living Community Movement Program (GERMAS)

GERMAS is a movement from Ministry of Health (MOH) that aims to promote a habit of healthy living and leave the habits and behavior that are less healthy. GERMAS action was also followed by promoting hygienic behavior and support for infrastructure programs on a community basis.

This program focuses on several agendas such as:

1. building access to fulfill drinking water needs, 2. public health installations and 3. build of habitable settlements. These are the basic infrastructure that forms the foundation of the

healthy living community movement.

Changes in community life patterns that are becoming more modern are one of the bases of the GERMAS or the Healthy Living Community Movement launched by the Ministry of Health of the Republic of Indonesia.

7. Healthy Indonesia Program with a Family Approach Guideline

Program from Ministry of Health (MOH) to ensure the state of well being of families. This program is developed by defining:

a. Recognize developmental disorders on the health of each family member,

b. Make decisions for correct action to achieve proper health, c. Provide care to sick family member, d. Maintaining an atmosphere at home, that is beneficially for the health

of each family members, e. Good communication between families and health service facilities.

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4. Japan 1. Self-Medication Tax deduction

Consumers spending more than JPY 12,000 in a year on OTC drugs that were switched from Rx are eligible for tax deduction; the cost exceeding the limit is deducted from the consumer’s taxable income. Japan Self-Medication Industry (JSMI) has been promoting this system since its inception in 2016, by publishing booklets and posters, sponsoring newspaper articles and advertising. JSMI has been negotiating with the government to expand the scope of the eligible OTC drugs as well as to lower the minimum consumption.

JSMI analyzes the statistics on the consumers receiving the deduction as well as the financial benefits they enjoy to suggest improvements to the mechanism to the authority.

2. Communication with Health Authority

Japan Self-Medication Industry has been having periodical formal meetings with high-rank officials of Ministry of Health Labor and Welfare (MHLW). The topics discussed usually include those on promotion of self-medication. In 2018 there were held two such meetings.

3. Promotion of Self-medication at community pharmacies

JSMI supported the Japan Pharmacist Association, in its training the pharmacists at the specially designated “Health Support Pharmacies” in 2016.

4. Promotion of Rx-to-OTC Switch

In the new Rx-to-OTC switch mechanism established in 2016, JSMI has been playing an important role of provided MHLW with the information on the switch candidates.

5. “Self-medication” Handbook

Since 2002, JSMI has been publishing the Handbook (2019 version: A5 size, 40 pages) issuing about 200,000 copies. The Self-Medication Handbook is an information booklet on OTC medicines and self-medication designed to be understandable for wide age groups, from 10-year-olds to the elderly. The handbook is distributed in pharmacies and at consumer events across Japan.

6. Press Conference

JSMI organizes Press Conferences after major annual events, including New Year Celebration Party in January and JSMI General Assembly in May. The Conference covers JSMI policies including those

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related to promoting Self-medication

7. Enlightenment on “Self-medication”

(1) Self-Medication Day Symposium

Twenty-fourth of July is the International Self-Care Day. JSMI with a help from the Ministry of Health, Labor and Welfare as well as JFSMI, organized a half-day symposium open to the public on the day in 2018 and 2019, inviting speakers from the regulatory authority, academia, Japan Pharmaceutical Association, and a chain pharmacy association.

(2) Kids’ School how to use drugs right

JSMI has been organizing enlightenment seminars in cooperation with educational institutes for parents and children to promote understanding of OTC drugs as well as the value of self-medication since 2011. In 2019, the seminars are held at 4 locations from the northern-most island of Hokkaido to the southern-most Kyushu for the total of 7 days. The seminars are held with supports from school of pharmacies of multiple universities.

(3) Jamboree at Fukutoku Forest “Accurate knowledge on OTC drugs for proper use”

JSMI has been organizing two-day outdoor event to encourage exact knowledge on and proper use of OTC drugs. The Jamboree takes place in the yard of “Fukutoku Shrine”, which worships a god of drug in the Japanese myth. The shrine in Tokyo has a yard of about 25m by 40m, which houses about 30 booths by OTC manufacturers, that disseminate information on their products. The event also features mock-pharmacies where one can experience compounding of drugs. The event in 2018 enjoyed more than 12,000 visitors.

8. Home Page

JSMI maintains various information in Japanese and English on OTC drugs and self-medication on its Website. The information is categorized and indexed according to drug classes as well as symptoms. Japan Self-Medication Data Base Center (JSM-DBC) was established in 2000 to provide an on-line database covering all the OTC drugs sold in Japan. The Website carries frequently asked questions on OTC drugs and self-medication and their answers. The questions have been continuously replenished from those received by the member companies.

9. Helping Self-diagnosis Measurements

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Since 2014, some of Japanese pharmacies started a service of measuring the HbA1c level. Consumers visiting pharmacies take a tiny volume of their blood by themselves and hand it to the pharmacist, who measures the blood level of the protein. When the measurement is high enough to justify medical intervention, the pharmacist recommends the consumer to see doctors.

JFSMI has organized “Council for Self-diagnosis Measurements” to offer to help the self-diagnosis efforts. The Council has been offering lectures on the relevant regulations and helping the pharmacies calibrate the analytical devices. As of 2019 there are about 360 pharmacies throughout Japan, offering in total around 80 measurements per month.

10. Advertisement Guidelines and Seminars

JFSMI periodically revises its voluntary guidelines that help understand and abide by the regulation issued by the regulatory authority. In 2019 the JFSMI guidelines were revised, whereupon the organization organized 2 seminars on OTC advertisements in Tokyo and Osaka in July. The seminars invited MHLW’s responsible officials and officers from JSMI Advertisement Committee as well as Japan Advertising Review Organization (JARO), overlooking Japan’s advertising in general.

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5. Korea 1. Operating Drug Advertisement Pre-Review Committee

In Korea, OTC drug is defined as a subject for preliminary review in public advertising, and The KPBMA has organized and operates a ‘Drug Advertisement Pre-Review Committee’ under the Pharmaceutical Affairs Act.

In addition to the reviewing activities, KPBMA advises the industry to make sure that the advertisements and promotions of OTC items are not curtailed by the pre-review system, and encourages the industry to make full use of new media such as SNS. The KPBMA also regularly hold seminar for drug advertisement pre-review system and case studies, discussion sessions for stakeholders to improve the review system.

2. Conducting study to revitalize OTC drug market

The KPBMA has commissioned relative academia to study on expanding the market of OTC drugs in Korea. The main contents are the expansion and improvement of Korean monograph items through the analysis of the domestic OTC drug status and comparative analysis with overseas cases.

3. Supporting the consumer enlightenment campaign by academic society

Various domestic societies disseminate information to consumers about the treatment of diseases and the proper use of drugs, and domestic pharmaceutical companies provide financial funding for the societies. The KPBMA runs the Code Deliberation Committee, which considers and approves such funding to support the proper operation of the society.

4. Supporting stable operation of the full ingredient labeling system

As of December 2017, the full ingredient labeling system has been implemented to provide the correct drug information to consumers. The KPBMA participates in a committee composed of governments, associations, companies, etc. to encourage stable settlement of the system and present industry opinions to the government.

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6. Philippines

1. Events for promotion of self-medication, hosted by the organization or in which the organization was involved

Member companies have participated in the Pilot Project on the Review of Over-the-Counter Applications of Philippine Food and Drug Administration.

2. Advertising activities utilizing media, in which the organization was involved

Meeting with Ad Standards Council regarding updates on new advertising regulations and lobbying concerns of member companies.

3. Activities for government and regulatory authorities, lobbying activities

1) Review of the Philippine Code of Ethics

2) Review of OTC guidelines

3) Review of Pharmacy Law (in partnership with Philippine Healthcare Association of the Philippines)

4) Created initial list of Pharmacist Only Medicines (in partnership with Philippine Pharmacists Association)

5) Active participation in the Pilot Project on Review of Over-the-Counter Applications (ROTCA) with Philippine Food and Drug Administration

6) Submitted position papers on the increased of fees and evaluation of permit applications

4. Joint activities with other organizations

1) Review of Pharmacy Law (in partnership with Philippine Healthcare Association of the Philippines)

2) Created initial list of Pharmacist Only Medicines (in partnership with Philippine Pharmacists Association)

5. Current situations and issues regarding the permeation of self-medication

October 2018: FDA issued Guidelines on the submission of application for the pilot project on ROTCA. Member companies of chosen associations had participated in the said project.

After the pilot project on ROTCA, there is no significant update yet from FDA on the full implementation on tier 1 and tier 2 systems application in the aim to reduce the processing timeline.

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7. Thailand 1. Self-CARER participation

TSMIA participated in the 4th self-CARER meeting during 20 – 22 March 2018, in Taipei, as industry observer / expert to support regualtors’ discussion. TSMIA also work in collaboration with Thai FDA in designing and delivery of Self-CARER University (SCU), which is the module training on self-CARE medicines to regulatory authorities (total 38 participants from 10 countries). TSMIA is also the leader in the workshop “Simplified registration in action”, in the SCU program.

2. Partnership with Pharmacist Group

TSMIA regularly supported the speaker and lecture for community pharmacist, and regulatory pharmacist groups, to build the network & partnership. The recent topics include: Medicine reclassification requirement and industry experience, OTC regulation updates etc.

3. Partnership with Thailand FDA

TSMIA provided technical/regulatory support to Thai FDA in revision of the Medicine Reclassification guideline (2nd revision) (year 2017), and related documents including standard process, timeline and evaluation fee. TSMIA also initiate the proposal in OTC regulatory reform to Thai FDA, such as abbreviated dossier for OTC, advertising guideline, which is being progressed in FDA discussion stage.

4. Annual TSMIA technical conference

TSMIA arranged the annual TSMIA technical conference “self-CARE: Keep Pace with self-care, OTC Drugs regulation and market trend” on 4th July 2019, in Bangkok. The conference provides the update on regulation, self-care policy and consumer health care market trend. There are about 100 persons attending the conference, with also the speaker from Thai FDA and industry. The aim is to promote self-CARE sector awareness within pharmaceutical industry.

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III. OTC Market in Asia-Pacific Region

By courtesy of Nicholas Hall

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Global OTC Overview 2018 provided by Nicholas Hall Europe in July 2019

All quoted data is for full year 2018 at manufacturers’ selling price from Nicholas Hall’s DB6 Global OTC Database. Does not include e-commerce and mail order sales unless otherwise stated Global overview: OTC growth continues to slow

There was little change in the retail CHC market during 2018, with sales growing by 4.0% vs the 4.1% recorded in 2017.

Factors behind the disappointing result include a relatively poor year for CCA (+3.7%) and a lack of switch, most notably in the US.

Growth slowed in both Europe (+2.6% vs +2.8%) and N America (+2.7% vs 3.2%), while there were only modest increases in Asia-Pacific (+4.6% vs +4.5%), LatAm (+9.5% vs +9.1%) and Rest of World (+7.2% vs +7.0%).

GIs (12.2% share of global sales) was the only major category to break the 5.0% growth barrier in 2018, buoyed especially by antinauseants (+10.5%) and antidiarrhoeals (+9.2%) following double-digit growth in China, the largest market for these subcategories. We are seeing an increase in use of certain types of GIs globally as eating habits change, such as consuming food on-the-go amid hectic lifestyles and stressful work environments.

No.1 major category by revenue, VMS (30.5% share) advanced by 4.3%, with below-average growth for leading subcategory multivitamins (+3.0%) partially offsetting the continued expansion of No.2 probiotics (+10.8%); six of the Top 10 global markets for this subcategory recorded double-digit increases (all 10 were positive), as product positioning widened beyond traditional use for GI disorders into other areas such as immunity and feminine intimate health.

Our industry is heavily reliant on seasonal factors, and an unremarkable year for CCA (20.6% share) played a significant part in the poor global trend. Only cough remedies (+5.3%) and chest rubs & inhalants (+7.5%) performed above average, while a terrible year for allergy remedies in the US (-1.2%, 57% share of global allergy revenue) dragged down the overall result for that subcategory (+2.6%). Combined growth of allergy remedies excluding the US was 8.0%.

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Derma (13.6% share) endured the lowest growth of all major categories (+2.7%), with below-average results in seven of the Top 10 global markets (including all of the Top 5). Haemorrhoid preparations and antiseptics & disinfectants performed best, advancing by just over 5%.

Analgesics (+4.0%; 13.4% share) and Lifestyle OTCs (+4.0%; 9.8% share) both slowed marginally vs 2017; the former was impacted by a notable drop-off in growth of topical treatments, caused mainly by the US.

Looking at the “all channels” version of the DB6 dataset – new for 2019 – which reports on topline figures of direct sales, internet & mail order plus key brands in selected leading markets, total OTC sales are worth US$174bn, of which store-based sales account for 78%, with direct sales generating 14%. Internet & mail order currently accounts for 9% of the “all channel” universe, with sales dominated heavily by VMS supplements in China and the US. However, this channel has seen a CAGR of 20% since 2014 and will continue to increase dramatically over the next decade. Global: Sales and growth by major OTC category 2018

US$mn 2017 US$mn 2018

Growth 2018/2017

Market share

GLOBAL TOTAL OTC SALES 130278.634 135436.415 4% 100.0

Vitamins, Minerals & Supplements

39585.107 41280.157 4.3% 30.5

Cough, Cold & Allergy 26881.036 27881.484 3.7% 20.6 Dermatologicals 17912.807 18389.111 2.7% 13.6 Analgesics 17419.722 18114.299 4% 13.4 Gastrointestinals 15736.155 16521.133 5% 12.2 Lifestyle OTCs 12743.807 13250.232 4% 9.8

Source: Nicholas Hall’s DB6 Global OTC Database (MSP) Key trends by region 2018 • Asia-Pacific’s OTC market grew by 4.6%, with a strong cold & flu season

in leading market China (+5.8%) partially offset by a weak performance

26

from key TCMs. Japan remained sluggish (+0.8%), while India (+9.3%) was the main growth driver among the core regional markets once again

• N America increased by 2.7%, closely mirroring the result of the key US market (+2.6%), which was hindered by a weak allergy season (allergy remedies -1.2%) and a lack of switch

• Europe advanced by 2.6%; W Europe continued to disappoint with a 1.6% increase, not helped by France remaining negative (-0.3%); CEE slowed to +5.2% following a lacklustre performance in key market and long-term growth driver, Russia (+1.7%)

• The best growth once again came in LatAm (+9.5%), although price inflation played a significant role in a number of markets, not least regional No.1 Brazil (+10.1%)

• Rest of World maintained its above-average performance (+7.2%) Global: OTC sales & growth by region 2018

US$mn 2017

US$mn 2018

Growth 2018/2017

Market Share %

GLOBAL TOTAL OTC SALES 130278.634 135436.415 4% 100

North America 35383.099 36334.142 2.7% 26.8 E & SE Asia 31233.943 32879.302 5.3% 24.3 Western Europe 24782.444 25176.814 1.6% 18.6 C & E Europe 10172.566 10701.212 5.2% 7.9 Rest of World 8305.457 8899.672 7.2% 6.6 Japan 7901.918 7967.131 0.8% 5.9 Latin America 6488.125 7102.22 9.5% 5.2 Indian Subcontinent 3306.029 3606.351 9.1% 2.7 Australasia 2705.054 2769.571 2.4% 2

Source: Nicholas Hall’s DB6 Global OTC Database (MSP) Marketers: M&A to shake-up the rankings

GSK retained the No.1 spot in the CHC leader board in 2018 and the company’s share is set to increase significantly once it assumes majority ownership of the j-v company incorporating Pfizer’s CH business. The all-equity agreement, announced in December 2018 and expected to complete in

27

H2 2019, will see the new GSK Consumer Healthcare potentially generate around 7% of global OTC sales, although brand divestments may reduce this.

GSK CH will be the No.1 marketer in all four major global DB6 regions (Asia, Europe, Americas and RoW), including all subregions with the exception of Japan and LatAm, and the No.1 player in four of the global Top 10 markets, including No.1 US (it will rank 2nd in global No.2 market, China).

RB, which grew by 2.2% in 2018 (2.4% share), will take Pfizer’s place in the Top 5, followed by P&G, which now encompasses the CH business of German-based Merck following completion of that deal in December 2018 for around €3.4bn (US$3.8bn) cash, but excludes Teva sales from the dissolved PGT j-v (effective 1st July 2018). P&G was the only Top 10 player to post above-market growth in 2018, boosted by flagship cough & cold brand Vicks (+6.3%), which recorded especially strong results in its No.2 market India (+13.9%), No.3 Brazil (+16.5%) and No.5 Mexico (+12.6%).

J&J leapfrogged Sanofi and Bayer into 2nd place, aided by continued growth from Tylenol (+6.3%) and the acquisition of natural products specialist Zarbee’s (announced in August 2018 for an undisclosed sum).

Despite a sales increase of 3.1%, Sanofi lost share owing to the spin-off of its Zentiva European generics business (split out of our 2018 annual sales total for the company) to Advent International for €1.9bn (US$2.1bn), which completed in October 2018.

Bayer was held back by poor performances in the US (-3.3%) and China (-9.3%); its operations in the latter market were hit by the reverse switch of Kang Wang antifungal and scalp treatments in September 2017, although the scalp product has now been reformulated and re-launched OTC and Bayer mentioned the brand as a contributing factor in strong A-P regional growth in Q3 2018.

28

Asia-Pacific overview 2018 provided by Nicholas Hall Europe in July 2019

All quoted data is for full year 2018 at manufacturers’ selling price from Nicholas Hall’s DB6 Global OTC Database. Does not include e-commerce and mail order sales

Asia-Pacific is the world’s largest region for OTC sales and growth was modestly above the global average in 2018 (+4.6% vs +4.0%).

Its performance is heavily dependent on China (+5.8%), where over 50% of regional sales are generated, while India was once again the most dynamic of the key markets (+9.3%).

However, as in previous years sluggish growth in No.2 market Japan (+0.8%) and underwhelming results in Australia and S Korea (both below 3%) dampened the overall increase.

While China continued to perform above average, growth was down vs 2017 (+6.2%), impacted mainly by a significant decline (-7.6%) in the US$1.5bn tonics & cure alls subcategory. Donkey hide gelatin brands, including the country’s No.1 OTC Dong-e E-Jiao (Dong-e E-Jiao / China Resources Pharmaceutical), have seen prices rise owing to a lack of raw materials (making them less affordable), while negative press reports over safety resulted in sales of No.3 tonic Hong Mao Medicated Wine (Neimenggu Hong Mao) falling by around 43%.

Meanwhile, the reverse switch of compound ketoconazole in September 2017 also seriously impacted general antifungals (-13.5%) and scalp treatments (-12.9%), with overall derma revenue increasing by only 2.0%.

Positive growth factors included a strong cold & flu season buoying No.2 major category CCA (+7.7%); marketer investment in TCM brands; development of paediatric / maternal healthcare products following the introduction of a two-child policy; and general recovery from the transition to China’s new two-invoice system.

The declining trend among tonics & cure alls saw total VMS growth fall to 4.7% (vs +7.6% in 2017), while growth also slowed in No.2 and No.3 subcategories calcium (+5.9% vs +7.4%) and multivitamins (+2.4% vs +5.4%). Probiotics continued to star however (+19.4%) thanks to product launches

29

(especially brands aimed at paediatric development). A flu outbreak early in the year boosted CCA, with systemic cold &

flu growth rising to 8.8% (vs +2.4% in 2017), while cough remedies advanced by a similar margin. Sore throat remedies & medicated confectionery also enjoyed a turnaround in fortunes (+5.7% vs -0.2% in 2017), owing mainly to category leader Golden Throat (Guangxi Golden Throat) rebounding following completion of distribution restructuring in 2018. GIs recorded a healthy increase once again (+7.9%) and was China’s best-performing major category in 2018, driven by antidiarrhoeals (+18.4%), where marketers are investing in A+P and increased distribution to take advantage of higher demand resulting from rising incidence of irregular and unhealthy eating patterns.

Liver & bile remedies also had a strong year (+17.4%) thanks to academic marketing and consumer education for key brands, while the switch to full OTC status of several key brands in early 2018 boosted antinauseants (+15.7%).

Analgesics growth was in line with the previous few years (+7.1%), with both topicals and systemics largely matching this rate.

Derma disappointed, although things are looking more positive for scalp treatments as Bayer reformulated and relaunched OTC Kang Wang in July 2018, and there were some strong results in other subcategories, including haemorrhoid preparations (+6.9%), antiseptics & disinfectants (+7.7%) and wound healers (+9.1%), while the more modest hair loss treatments enjoyed the best result (+19.1%) thanks to a rebound for category leader Bawang (Bawang) and A+P that aims to attract the younger generation.

Japan’s OTC market has been sluggish for many years, held back by

issues such as health insurance coverage encouraging consumers to visit a doctor instead of buying OTCs. Largest category VMS, which generates almost 40% of total sales, declined slightly (-0.5%) as the leading tonic drinks subcategory (-1.6%) continued to face competition from other sectors (such as energy drinks). The crucial vitamin B segment also fell (-9.5%), following a decline at a similar rate for dominant brand, Alinamin (Takeda).

Analgesics (+3.6%) performed best, benefiting from premium line extensions and the ageing population using pain-relieving OTCs to alleviate

30

aches & pains, with systemics especially dynamic (+6.0%). Future sales could benefit from the MHLW recommending the Rx-to-OTC switch of systemic naproxen in August 2018. CCA (+3.1%) also did well, especially allergy remedies (+9.6%). The subcategory was buoyed by a high incidence of seasonal allergies in 2018 and could be further boosted following the registration as Instruction-required Drugs in November 2018 of Rohto’s Alguard Clear Nose Seasonal Allergy and GSK’s Flunase Nasal Spray. The former launched in December 2018 and is the first flunisolide-based OTC allergy remedy in Japan.

While derma growth of 1.4% appears low, this was actually the best result for the major category in several years, aided by a strong level of NPD. GIs (-1.6%) and lifestyle OTCs (+0.5%) could not emulate this level of improvement.

India remained the main regional growth driver, with major categories contributing towards the positive result. No.1 by sales revenue, VMS (+9.3%) was aided by growth of over 12% for leading subcategory iron, while chyawanprash (+8.0%) recovered from a flat result in 2017; Dabur’s dominant entry reaped the benefits of strategic pricing implemented to mitigate the threat from a lower-cost mid-tier product from Patanjali, as well as enhanced efforts to encourage wider use throughout the year (such as to reduce the effects of pollution). GIs (+10.8%) recovered from lower consumer spending power resulting from demonetisation in Q4 2016, particularly in largest subcategory antacids (+12.5%). Demand for antacids has been boosted by the growing incidence of dyspepsia, particularly in urban areas, which is linked to modern hectic lifestyles and diet. Growth in laxatives continued to improve (+12.1%), boosted by marketers’ efforts to reduce the taboo associated with constipation.

CCA sales were up by 10.4% in 2018; air pollution has boosted demand in product categories such as sore throat remedies & medicated confectionery (+12.2%) owing to the increased incidence of respiratory ailments in recent years. No.1 subcategory cough remedies grew by 9.7%, driven by the strong performance of No.1 entry Phensedyl (Abbott). Several cough remedies have been affected by the decision to ban over 300 fixed dose combination

31

medicines in early 2016. The Delhi High Court quashed the order in December of that year but it was reinstated in September 2018, although some affected CCA brands such as Phensedyl and Piriton Expectorant (GSK) were granted exemption by the Supreme Court as they were being manufactured prior to 1988 (the government’s cut-off date beyond which FDCs were not being assessed). Meanwhile, in February 2019 the government rescinded a ban on the sale of FDCs formulated with paracetamol, caffeine, phenylephrine + chlorphenamine, with immediate effect. The formulation is used in systemic cold & flu remedies (+9.0%) such as Alex Cold (Glenmark), Zedex Cold (Wockhardt) and Hatric 3 (Aristo). An 8.1% increase for analgesics was driven by a 10.2% upturn for the larger topicals category, where faster-acting formats such as sprays and gels are becoming more popular owing to rising numbers of fitness-conscious consumers in urban areas looking for fast and convenient pain relief.

There is also a burgeoning topical menstrual pain relief niche, with Redcliffe Hygiene launching Pee Safe Feminine Cramp Relief Roll On in November 2018 and Sanfe Period Pain Relief Roll on (Sanfe) launched in March 2019.

The systemics category has struggled in recent years, however factors such as worsening dengue fever outbreaks helped sales to grow by 5.2% in 2018. Derma and lifestyle OTCs were the only major categories to record slower growth vs 2017, although both remained relatively buoyant (+8.4% and +6.2% respectively).

Although Australia’s growth remained well below average in 2018, the 2.4% advance was its best result for several years, as largest major category VMS recovered from a slight decline in 2017 with an increase of over 5%.

A resurgence in daigou sales to China was an important factor. Probiotics was the best-performing subcategory (+18.8%), while vitamin C (+14.1%) and iron (+13.8%) also impressed.

However, a sluggish result from CCA (+0.8%) and a decline for analgesics (-3.7%), which has struggled since the reverse-switch of codeine-based brands in February 2018, offset the overall result.

32

S Korea performed slightly better than Australia. All major categories recorded growth of around 2-3% with the exception of lifestyle OTCs, which declined by almost 1%.

In Indonesia, growth improved slightly to 2.0% in 2018 vs 1.4% in 2017 but this is still below the regional average as Indonesia is recovering from recent economic challenges that have reduced consumer spending power. As such, all major categories grew by low single digits. Asia-Pacific: OTC sales & growth by country 2018

US$mn 2017

US$mn 2018

Growth 18/17

Market Share %

OTC Sales - Asia 45146.944 47222.355 4.6% 100 China 23777.243 25157.883 5.8% 53.3 Japan 7901.918 7967.131 0.8% 16.9 India 2985.453 3263.838 9.3% 6.9 Australia 2375.791 2432.596 2.4% 5.2 South Korea 2152.456 2210.471 2.7% 4.7 Indonesia 1487.94 1518.316 2.0% 3.2 Philippines 801.934 845.153 5.4% 1.8 Thailand 785.83 821.061 4.5% 1.7 Taiwan 674.532 701.526 4.0% 1.5 Hong Kong 541.973 569.152 5.0% 1.2 Vietnam 432.088 449.502 4.0% 1 Malaysia 350.038 366.597 4.7% 0.8 Pakistan 320.576 342.513 6.8% 0.7 New Zealand 329.263 336.975 2.3% 0.7 Singapore 229.909 239.639 4.2% 0.5

Source: Nicholas Hall’s DB6 Global OTC Database (MSP)

33

Asia-Pacific: OTC sales & growth by major category 2018

US$mn 2017

US$mn 2018

Growth 18/17

Market Share %

OTC Sales - Asia 45146.944 47222.355 4.6% 100 Vitamins, Minerals & Supplements

15532.85 16122.4 3.8% 34.1

Cough, Cold & Allergy 8564.576 9085.398 6.1% 19.2 Gastrointestinals 5822.552 6189.441 6.3% 13.1 Analgesics 5476.71 5769.722 5.4% 12.2 Dermatologicals 5551.948 5695.094 2.6% 12.1 Lifestyle OTCs 4198.307 4360.299 3.9% 9.2

Source: Nicholas Hall’s DB6 Global OTC Database (MSP)

Annex 1: Dossier Requirements for OTC

Registration

1

Country: Indonesia

X: Required, Y:Required depending on the drug, Blank: Not required.

DataCategory

test/description

NewChemical

Entity(DirectOTC)

SwitchOTC

Newadministration route

OTC

NewdosageformOTC

Newcombi-nationOTC

Mono-graph-

compatible,generic

OTCOrigin andBackground X X X X X

Use in foreigncountries X X X X X

Comparison withother drugs X X X X X X

Chemical Structureand Physico-chemicalproperties

X X X

Manufacture X X X X X

Specification X X X X X X

long-term X Y1 Y1 Y1 Y1 Y1

stress X X X X

accelerated X X X X X X

efficacy X X X X

safety X X X X

others X X X X

Absorption X X X X XDistribution X

Metabolism XExcretion X

Bioequivalence X

Others X

single-dose X Y Y Y

repeated dose X Y Y Y

genotoxicity X

carcinogenicity X

reproductive toxicity X

local irritation X Y Y Y

others X Y Y

Clinical clinical X X1 X1 X1 X2

Labelling Package insert X X X X X

Toxicity

X1: more than 5 trial sites, more than 150 casesX2: more than 3 trial sites, more than 60 cases

Country: Indonesia

General/Background

Manu-factureand Speci-

fication

Stability

Pharma-cology

ADME

Y1: For drugs whose stability for 3 years cannot be estimated with the stress test, long-term stabilitytest is required.

2

Country: Japan


Data Category test/description

NewChemical

Entity(DirectOTC)

SwitchOTC

Newadminist

rationrouteOTC

Newdosage

form OTC

Newcombi-nationOTC

Mono-graph-

compatible,generic

OTCOrigin andBackground of drug X X X X X

Use in foreigncountries

X X X X X


Chemical Structureand Physico-chemical properties

X

Manufacture X


long-term X Y1 Y1 Y1 Y1 Y1stress Xaccelerated X Y1 Y1 Y1 Y1 Y1efficacy X

safety X

others X

Absorption X Y Y Y Y

Distribution X

Metabolism XExcretion XBioequivalence XOthers Xsingle-dose X Y Y Y

repeated dose X Y Y Y

genotoxicity Xcarcinogenicity Xreproductive toxicity Xlocal irritation X Y Y Yothers X Y Y

Clinical clinical X X1 X1 X1 X2

Labelling Package insert X X X X X

Toxicity

X1: more than 5 trial sites, more than 150 casesX2: more than 3 trial sites, more than 60 cases

Country: Japan

General/Background

Manufactureand

Specification

Stability

Pharmacology

ADME

Y1: For drugs whose stability for 3 years cannot be estimated with the stress test, long-term stability test isrequired.

3

Country: Korea


Data Category test/description

NewChemical

Entity(DirectOTC)

SwitchOTC

Newadministr

ationrouteOTC

NewdosageformOTC

Newcombi-nationOTC

Mono-graph-

compatible,generic

OTC

Origin andBackground of drug X X X X X

Use in foreigncountries

X X X X X

Comparison withother drugs X X X X X


X Y Y Y

Manufacture X X X X X

Specification X X X X

long-term X X X X

stress X

accelerated X X X X

efficacy Y Ysafety Yothers

Absorption Y Y

Distribution Y Y

Metabolism Y Y

Excretion Y Y

Bioequivalence Y

Others

single-dose Y Y Y

repeated dose Y Y Y

genotoxicity Y

carcinogenicity Y

reproductive toxicity Y Y

local irritation Y

others Y Y Y

Clinical clinical Y X Y X

Labelling Package insert

Toxicity

Country: Korea

General/Background

Manufactureand

Specification

Stability

Pharmacology

ADME

4

Country: Philippines Country: Philippines 1


Data Category test/description New Chemical Entity (DirectOTC) Switch OTC New administration route OTC

Origin andBackground of drug X

Xclassification of product from country

of origin

XJustification for the changes

proposed

Use in foreigncountries X

XList of countries where product is

marketed and correspondingclassification of the product, approval

letters

Xapproval letters from reference

regulatory authorities or thecountry of origin

Comparison withother drugs


Xunit dose formulation, tech specs

raw materials, COA rawmaterials, analytical procedures

Xdescription, formulation

Manufacture XSpecification Xlong-term Xstressaccelerated Xefficacy Xsafety Xothers XAbsorption XDistribution XMetabolism XExcretion X

Bioequivalence Xwhere applicable

Others Xdissolution profile

single-dose Xrepeated dose Xgenotoxicity Xcarcinogenicity Xreproductive toxicity Xlocal irritation Xothers X

Clinical clinical

XPart IV as per ACTD Clinicalexpert reports and/or clinical

trial reports

XPart IV as per ACTD

XPart IV as per ACTD Clinical

expert reports and/or clinical trialreports

Labelling Package insertX

including all other impactedlabels (e.g. carton)

Xincluding all other impacted labels

(e.g. carton)


(e.g. carton)

OtherRequirements(PH specific)

CPPADR report showing low occurrence of

drug interaction (clinicallyinsignificant)

approved SmPC/PIL from countryof origin or approved referenceregulatory agency

Toxicity

General/Background

Manufactureand

Specification

Stability

Pharmacology

ADME

5

Country: Philippines Country: Philippines 2


Data Category test/description New dosage form OTC New combi-nationOTC

Mono-graph-compatible, genericOTC

Origin and Background ofdrug

XJustification as line extension X

Use in foreign countries X

Comparison with otherdrugs

Chemical Structure andPhysico-chemicalproperties

Xunit dose formulation, tech specs raw

materials, COA raw materials,analytical procedures

Xunit dose

formulation, techspecs raw materials,COA raw materials,

analytical procedures

Xunit dose formulation, tech specs

raw materials, COA raw materials,analytical procedures

Manufacture X X XSpecification X X Xlong-term X X Xstressaccelerated X X Xefficacy Xsafety Xothers XAbsorption XDistribution XMetabolism XExcretion X

Bioequivalence Xwhere applicable

Xwhere applicable

Xwhere applicable

Others Xdissolution profile

Xdissolution profile

Xdissolution profile

single-dose Xrepeated dose Xgenotoxicity Xcarcinogenicity Xreproductive toxicity Xlocal irritation Xothers X

Clinical clinical

XPart IV as per ACTD

Clinical expertreports and/or

clinical trial reports

Labelling Package insertX

including all other impacted labels(e.g. carton)

Xincluding all other

impacted labels (e.g.carton)


(e.g. carton)

Other Requirements(PH specific) CPP CPP CPP

ADME

Toxicity

General/Background

Manufacture andSpecification

Stability

Pharmacology

6

Country: Taiwan


DataCategory test/description

NewChemical

Entity(Direct OTC)

SwitchOTC

Newadministr

ationrouteOTC

Newdosage

form OTC

Newcombi-nationOTC

Mono-graph-

compatible,generic

OTC

Origin andBackground of drug X X X X X

Use in foreigncountries X X X X X



X

Manufacture X X X X X X


long-term X X X X X X

stress Y Y Y Y Y Y

accelerated X X X X X X

efficacy X X X X

safety X X X Y X

others Y Y Y YAbsorption X X XDistribution X X XMetabolism X X XExcretion X X XBioequivalence Y Y2Others Y1 Y1 Y1single-dose X X Y Xrepeated dose X Y Y Ygenotoxicity Xcarcinogenicity Xreproductive toxicity X Y Ylocal irritation X Y Yothers X Y Y

Clinical clinical X Y X Y2 XLabelling Package insert X X X X X X

Toxicity

Y1: BA is required.Y2: Either BE or BA with Clinical is required.

Country: Taiwan

General/Background

Manufactureand

Specification

Stability

Pharmacology

ADME

7

Annex 2: Rx-to-OTC Switch Products in

Member Countries

8

Country: China

No. AuthorizedYear Product Name Ingredient Name Dosage Form Drug Efficacy Maximum Dose / Day Note

1 Ibuprofen Arginine granule Ibuprofen Arginine Oral antipyretic/analgesia 0.8g�calculate asibuprofen�

2 Vitamins and MincralsDispersible Tablets

VitaminA , VitaminD, VitaminE ,VitaminB1, VitaminB2,VitaminB6, VitaminB12, iron,copper, Zinc, magnesium,nicotinamide, calciumpantothenate, calciumhydrophosphate, L-Lysine,lipotropin , inositol, VitaminC,iodine, manganese, potassium

Oral

Prevention and treatmentof various diseasescaused by the lack ofvitamins and minerals.

VitaminA 5000IU,VitaminD400IU, VitaminE10mg, VitaminB1 5mg,VitaminB2 5mg, VitaminB60.5mg, VitaminB12 1ug,iron 10 mg, copper 1mg, Zinc0.5mg, magnesium 1mg,nicotinamide 15mg, calciumpantothenate 5mg, calciumhydrophosphate 558mg, L-Lysine 25mg, lipotropin50mg, inositol 50mg,VitaminC 50mg, iodine100ug, manganese 1mg,potassium 10mg

3 hydroxypropyl methylcelluloseeye drop hydroxypropyl methylcellulose Eye drop eliminate Eye discomfort 8ml�24mg 1�2 drop per time,3

times per day

4 Bacillus subtilis capsule Bacillus subtilis Oral diarrhea relief 2.25g

5 Ketotifen Fumarate eye drop ketotifen fumarate Eye drop allergic conjunctivitis5ml:2.5mg�calculate asketotifen�

1�2 drop per time, 4times per day

6 nicotine Patch/ nicotine transdermal patch nicotine Patch smoking deterent

patch�15mg/16htransdermal patch�21mg/24h

7 Levocabastine HydrochlorideNasal Spray Levocabastine Hydrochloride Nasal antiallergic

400ug�calculate asLevocabastine per nostril�

8 caffeine cold/influenza 90mg9 kalium sulfoguajacolicum; Oral cold/influenza 180mg

10 mephedrine Oral cold/influenza 28.8mg11 chlorpheniramine maleate Oral cold/influenza 7.2mg12 acetaminophen Oral cold/influenza 720mg

13 pseudoephedrine sulfate Oral cold/influenza/anaphylactic rhinitis 240mg

14 acetaminophen Oral cold/influenza/anaphylactic rhinitis 2g

15 loratadine Oral cold/influenza/anaphylactic rhinitis 10mg

16 dl-camphor Patch analgesic 28.4mg17 Vitamin E Patch analgesic 48mg18 l-menthol Patch analgesic 132mg19 methyl salicylate Patch analgesic 144mg

20 chlorpheniramine maleate Oral antibechic 4.5mg

21 mephedrine; Oral antibechic 45mg

22 guaifenesin Oral antibechic 225mg

23 dextromethorphan hydrobromide Oral antibechic 67.5mg

24 pseudoephedrine sulfate Oral cold/influenza 240mg

25 loratadine Oral cold/influenza 10mg

26 chlorpheniramine maleate Eye drop Relieve thevisual fatiguesymptoms 1ml:0.1mg

27 vitamin B6 Eye drop Relieve thevisual fatiguesymptoms 1ml:1mg

28 taurine Eye drop Relieve thevisual fatiguesymptoms 1ml:1mg

29 prostigmine methyl sulfate Eye drop Relieve thevisual fatiguesymptoms 1ml:0.01mg

30 calcium hydrophosphate Oral supplement Calcium 1g

31 lysine hydrochloride Oralpromote the normalgrowth and developmentof children

1g

32 Polyene Phosphatidyl cholinecapsule Polyene Phosphatidyl choline Oral

assist to improve the toxicliver injury in patients withfatty liver and hepatitis /anorexia, right upperabdominal pressure.

1368mg

33 orlistat tablet orlistat Oral obesity / overweight 360mg

Note: China had no OTC active ingredient monography, HA approved switch based on product case by case.

Ingredients & Dosages Transferred From Rx-to-OTC Status

Compound NeostigmineMethylsulfate and Taurine EyeDrops;

Loratadine andPseudoephedrine SulfateSustained Release Tablets;

2011

Guaifenesin�DextromethorphanHydrobromide�Methylephedrine Hydrochlorideand Chlorphenamine MaleateSyrup

Compound Methyl Salicylateand Menthol Patch

Loratadine Paracetamol andPseudoephedrine SulphateSustained -release Tablet

Compound Paracetamol andSulfogaiacol Oral Solution

Lysine Hydrochloride andCalcium Hydrogen PhosphateGranules

1�2 drop per time,4-6 times per day

9

Country: China

No. AuthorizedYear Product Name Ingredient Name Dosage Form Drug Efficacy Maximum Dose / Day Note

34 hydrochloric acid granule hydrochloric acid Oral analgesic 1.44g

35 Smectite Suspension Smectite Oral Antidiarrheal 9g36 chlorpheniramine maleate Oral cold/influenza 12mg37 dextromethorphan hydrobromide Oral cold/influenza 90mg38 pseudoephedrine hydrochloride Oral cold/influenza 180mg39 acetaminophen Oral cold/influenza 1950mg

40 dimeticone Oral antiflatulent 160mg

41 calcium carbonate Oral antiacid 3360mg

42 lactulose oral solution lactulose Oral laxative 20g43 glucosamine sulfate tablet glucosamine sulfate Oral analgesia 1.5g

44 extractum belladonnae Oral Relief of pain caused bysmooth muscle spasm 30mg

45 Vitamin U II Oral gastric mucosalprotection 150mg

46 aluminium hydroxide Oral antiacid/gastric mucosalprotection 420mg

47 loratadine granule/LoratadineOrally Disintegrating Tablets loratadine Oral anaphylactic

rhinitis/idiopathic urticaria 10mg

48 Ibuprofen Arginine Tablets Ibuprofen Arginine Oral antipyretic/analgesia 0.8g�calculate asibuprofen�

49 Ketotifen Fumarate NasalSprays ketotifen fumarate Nasal anaphylactic rhinitis 0.9mg�calculate as

ketotifen�

50 Domperidone OrallyDisintegrating Tablets; Domperidone Oral prokinetic agents 30mg

51 phenylephrine hydrochloride Oral cold/influenza 20mg52 caffeine Oral cold/influenza 120mg53 brompheniramine maleate Oral cold/influenza 20mg54 bromhexine hydrochloride Oral cold/influenza 32mg55 acetaminophen Oral cold/influenza 1120mg56 Vitamin B6 external eczema/dermatosis 1g: 1.5mg57 fluocinonide external eczema/dermatosis 1g: 0.01mg

58 hydrotalcite granule hydrotalcite Oral antiacid/gastric mucosalprotection 2g

59 acetylcysteine tablet acetylcysteine Oral expectorant 0.6g

60 amorolfine hydrochlorideliniment amorolfine hydrochloride external Fungal nail/Toenail

infection 5% 1�2 times per week

61 clotrimazole vaginaleffervescent tablets clotrimazole vaginal Candida vaginal disease 0.5g

62 magnesium hydroxide Oral antiacid 330mg63 calcium carbonate Oral antiacid 1.6g64 famotidine Oral antiacid 20mg65 ibuprofen spansule ibuprofen Oral antipyretic/analgesia 0.8g66 levonorgestrel tablet levonorgestrel Oral contraception 1.5mg67 ibuprofen dispersible tablet ibuprofen Oral antipyretic/analgesia 0.8g

68 minoxidil liniment minoxidil external male patternalopecia/alopecia areata 100mg 60ml:3g. no more

than 2ml per day

69 pepsin oral solution pepsin Oral digestive Pepsin activity per 1 ml of notless than 14 units

20ml one time�2-3times per day

70 Drospirenone Oral contraception 3mg71 ethinyloestradiol Oral contraception 0.03mg

72 piroxicam paste piroxicam external analgesia 0.04g10g:0.1g�1-2 timesper day, 1-2g pertime

73 orlistat capsule orlistat Oral obesity / overweight 180mg

2014

famotidine Fytic Acid chewabletablet

2015

2016

Drospirenone ethinyloestradioltablet

2012

Compound DextromethorphanHydrobromide dry suspensions

calcium carbonate dimeticonechewable tablet

Vitamin U belladonna aluminumdispersible tablets

2013

compoundParacetamol,BromhexineHydrochloride andBrompheniramine MaleateCapsules

fluocinonide Vitamin B6 paste 2�3 times per day

Note: China had no OTC active ingredient monography, HA approved switch based on product case by case.


10

1 soysterol oral hypercholesterolemia 600mg2 sodium picosulfate oral laxative 7.5mg3 exalamide external tinea pedis/ringworm 50mg (*2-3 times per day)

4 dimemorfan oral antitussive/expectorant 60mg5 indomethacin external external analgesic 1%6 ibuprofen(450mg/day) oral analgesic 450mg7 1986 polyenephosphatidylcholine oral hypercholesterolemia 1500mg8 Sodium polyethylenesulfonate external analgesic 1%9 butylscopolammonium bromide oral gastrointestinal antispasmodic 30mg

10 bromhexine hydrochloride oral cold remedy 12mg11 cetraxate hydrochloride oral gastrointestinal 600mg12 timepidium bromide hydrate oral gastrointestinal antispasmodic 45mg13 ciclopiroxolamine external tinea pedis/ringworm 1%14 miconazole nitrate external tinea pedis/ringworm 1%15 isothipendyl hydrochloride oral (dermatological) toothache/pyorrhea 2mg16 gefarnate oral gastrointestinal 150mg17 econazole nitrate external tinea pedis/ringworm 1%18 carbocysteine oral antitussive/expectorant 750mg19 hepronicate oral bloodstream disorder 100mg20 loperamide hydrochloride oral antidiarrheal 1mg21 ubidecarenone oral cardiac 30mg22 hydrocortisone butyrate external eczema/dermatitis 0.05%23 mequitazine oral antiallergic 6mg24 bisoxatin acetate oral laxative 60mg25 ibuprofenpiconol external acne 3%26 tolciclate external tinea pedis/ringworm 1%27 ufenamate external eczema/dermatitis 5%28 eprazinone hydrochloride oral antitussive/expectorant 90mg as anhydride29 tioconazole external tinea pedis/ringworm 1%30 mecobalamin oral vitaminB12 1500µg31 prednisolone valerate acetate external eczema/dermatitis 0.15%32 calcium L�aspartate oral calcium 1200mg33 ibuprofen* oral cold remedy 450mg34 sulconazole nitrate external tinea pedis/ringworm 10%35 bifonazole external tinea pedis/ringworm 1%36 mequitazine** oral cold remedy 4mg37 oxiconazole nitrate external tinea pedis/ringworm 1%38 piroxicam external external analgesic 5mg/1g39 ketoprofen external external analgesic 0.3%40 oxethazaine oral gastrointestinal 5mg41 trimebutine maleate oral gastrointestinal 300mg42 felbinac (0.5%) external external analgesic 0.5%43 pirenzepine hydrochloride hydrate oral gastrointestinal 47.1mg44 sodium cromoglicate eye drop antiallergic 100mg/100ml45 cimetidine oral gastrointestinal 300mg46 famotidine oral gastrointestinal 20mg47 ranitidine hydrochloride oral gastrointestinal 63mg48 1998 sofalcone oral gastrointestinal 300mg49 2000 teprenone oral gastrointestinal 112.5mg50 2001 nicotine oral (chewing gum) stop smoking 8-24mg51 amorolfine hydrochloride external tinea pedis/ringworm 0.5%52 butenafine hydrochloride external tinea pedis/ringworm 1g/100ml53 neticonazole hydrochloride external tinea pedis/ringworm 1%54 terbinafine hydrochloride external tinea pedis/ringworm 1%55 pranoprofen eye drop analgesic 50mg/100ml56 roxatidine acetate hydrochloride oral gastrointestinal 75mg57 nizatidine oral gastrointestinal 150mg58 ketotifen fumarate nasal antiallergic 50mg/100ml59 lanoconazole external tinea pedis/ringworm 1%60 tiquizium bromide oral gastrointestinal antispasmodic 15mg61 azelastine hydrochloride oral antiallergic 2mg62 ketotifen fumarate *1 oral antiallergic 50mg/100ml63 triamcinolone acetonide external stomatitis 0.1%

1988

1989

2005

2006

1995

1992

1993

1994

1997

1991

Country: Japan

1987

2002

1983


No. Note

1990

1985

AauthorizedYear

Ingredient Name Ddosage Form Drug Efficacy Maximum Dose/Day

11

64 aciclovir external oral herpes 5%65 ketotifen fumarate eye drop antiallergic 50mg/100ml66 ambroxol hydrochloride oral expectorant 45mg67 felbinac (3.5%)*3 external external analgesic 3.5%68 flavoxate external overactive bladder/residual urine 600mg69 isoconazole nitrate vaginal vaginal candidiasis 100mg70 nicotine*1 patch stop smoking 78mg71 emedastine Fumarate oral antiallergic *2 2mg72 miconazole nitrate vaginal vaginal candidiasis 100mg73 miconazole nitrate external vaginal candidiasis 1%74 isoconazole nitrate external vaginal candidiasis 1%75 diclofenac sodium external external analgesic 1%76 vidarabine external oral herpes 3%77 loxoprofen sodium hydrate oral analgesic 120mg78 epinastine hydrochloride oral antiallergic 10mg79 troxipide oral gastrointestinal 300mg80 oxiconazole nitrate*1 vaginal vaginal candidiasis 100mg81 beclomethasone dipropionate nasal antiallergic 0.1%82 clotrimazole*1 vaginal vaginal candidiasis 100mg83 oxymetazoline hydrochloride nasal rhinitis 50mg/100ml84 acitazanolast hydrate eye drop antiallergic 100mg/100ml85 pemirolast potassium oral antiallergic 10mg86 mequitazine oral antiallergic 4mg87 fexofenadine hydrochloride oral antiallergic 120mg88 neticonazole hydrochloride external vaginal candidiasis 1%89 ethyl icosapentaenoate*1 oral 1800mg90 cetirizine hydrochloride oral antiallergic 10mg91 ibuprofen(600mg/day) oral analgesic 600mg92 trimebutine maleate*1 oral irritable bowel syndrome 10mg93 pemirolast potassium*1 eye drop antiallergic 100mg/100ml94 tranilast eye drop antiallergic 0.5%95 ebastine oral antiallergic 5mg96 2014 alminoprofen oral analgesic 400mg97 sodium fluoride external dental prophylaxis 50mg/100ml98 loxoprofen sodium hydrate*1 external analgesic 120mg99 beclomethasone dipropionate (0.1%) nasal antiallergic 0.1%

100 epinastine hydrochloride(20mg) oral antiallergic 20mg101 Bepotastine Besilate oral antiallergic 20mg102 Loratadine oral antiallergic 10��103 2018 Flunisolide nasal antiallergic 25.5mg/100ml104 2019 Fluticasone propionate nasal antiallergic 50mg/100ml

*1 ingredients additionally authorized for new effects and/or new dosage forms.

*3 ingredients additionally authorized for new dose (amount)

2007

2008

2009

Country: Japan

Ingredients & Dosages Transferred From Rx-to-OTC Status No. Aauthorized

YearIngredient Name Ddosage Form Drug Efficacy Maximum Dose/Day Note

*2 dermatological effect (against swelling on the skin and itching caused from nettle rash,eczema and skin-eruption) in addition to the effect against rhinitis.

2010

2011

2012

2013

2015

2017

12

1 2013 oxolamine citrate oral antitussive/expectorant 1200mg2 2013 neltenexine monohydrate oral antitussive/expectorant 112.2mg3 2013 nizatidine oral gastrointestinal 150mg

4 2013

glycyrrhiza/chlorpheniraminemaleate/guaifenesin/dl-methylephedrinehydrochloride/diprophylline/armeniacaesemen/liriopis tuber/polygalae radix

oral antitussive/expectorant 40ml 200mg asguaifenesin

5 2013 lanoconazole external antifungal 10mg/ml6 2013 ranitidine hydrochloride oral gastrointestinal 150mg

7 2013 levocabastine hydrochloride nasal antiallergic 0.05g/100ml aslevocabastine

8 2013 loratadine[0.1g] oral antiallergic 10mg9 2013 loratadine[10mg] oral antiallergic 10mg

10 2013 loperamide hydrochloride oral antidiarrheal 16mg

11 2013

glycyrrhiza/armeniacae semen/dl-methylephedrinehydrochloride/polygalaeradix/chlorpheniraminemaleate/guaifenesin/liriopis tuber

oral antitussive/expectorant 40ml

12 2013 anhydrous liquid lanolin eye drop ophthalmic remedy 3% 30mg/g13 2013 benzydamine hydrochloride gargle anti-inflammatory 67.5mg

14 2013 boehmite oral gastrointestinal 3.636g as aluminiumoxide

15 2013 bisacodyl oral laxative 15mg

16 2013 tocopherolacetate[4.53iu]/ubidecarenone[10mg] oral cardiovascular 30mg as

ubidecarenone17 2013 ubidecarenone[5mg] oral cardiovascular 30mg18 2013 ubidecarenone[10mg] oral cardiovascular 30mg19 2013 ethylene oxide[8.6g/cm2] - sterilization of surgical instruments -20 2013 ethylene oxide[89wt.%] - sterilization of surgical instruments -21 2013 ethylene oxide[10wt.%] - sterilization of surgical instruments -22 2013 cetrimide eye drop ophthalmic remedy 0.01% 0.1mg/g

23 2013

dizet-100/scopolia/calciumcarbonate/aluminiumhydroxide/magnesiumcarbonate/sodium bicarbonate

oral digenstive 7.5g

24 2013 amorolfine hydrochloride[2.788mg] external antifungal 0.2788% 2.788mg/g25 2013 amorolfine hydrochloride[5.574g] external antifungal 5.574g/100ml26 2013 acrivastine oral antiallergic 8mg27 2013 erdosteine oral antitussive/expectorant 900mg28 2013 sodium N-acetylaspartyl glutamate eye drop antiallergic 49mg/ml29 2013 neticonazole hydrochloride external antifungal 10mg/ml30 2013 fexofenadine hydrochloride oral antiallergic 120mg31 2013 sodium chloride[20mg] eye drop ophthalmic remedy 2% 20mg/g32 2013 sodium chloride[50mg] eye drop ophthalmic remedy 50mg/ml33 2013 isopropanol/propanol external antiseptic/germicide -34 2013 sodium cromoglycate[20mg] eye drop antiallergic 20mg/ml35 2013 sodium cromoglycate[40mg] eye drop antiallergic 40mg/ml36 2013 clotrimazole/hydrocortisone external antifungal 1% 10mg/g

37 2013 berberine chloride/albumintannate/acrinol oral antidiarrheal 1200mg as albumin

tannate

38 2013scopolia/sodiumbicarbonate/magnesium oxide/ l-menthol/gentian/calcium carbonate

oral gastrointestinal 1200mg as sodiumbicarbonate

39 2013 calcium carbonate oral gastrointestinal 5g40 2013 troxerutin eye drop ophthalmic remedy 50mg/ml41 2013 phenylephrine hydrochloride nasal nasal decongestant 5mg/ml42 2013 polyethylene glycol oral laxative 17g

The Reclassification has been made in 2013 and there will be additional reclassification in every 5 years or in case of necessity.

Country : Korea


No. AauthorizedYear

Ingredient Name Ddosage Form Drug Efficacy Maximum Dose/Day Note

13

1 2009 BIFONAZOLE Cream Anti-fungal agent -

2 2009 AMOROLFINEHYDROCHLORIDE Cream Anti-fungal agent -

3 2010 HORSE-CHESTNUTEXTRACT

RELEASETABLET

Herbal supplement forcirculatory health 100mg (triterpene glycosides)

4 2011 LORATADINE TABLETS Anti-histamine agent 10mg

5 2011 LORATADINE SYRUP Anti-histamine agent 10ml (10mg)

6 2012 Enoxolone/Rongalite GingivalPaste

Anti-inflammatoryagent for gum care -

7 2013 CERNITINT60/CERNITIN-GBX Tablets Anti-inflammatory &

Decongestant 360mg/18mg

8 2013 CLOTRIMAZOLE VAGINALTABLETS Anti-fungal agent 500mg

9 2013 CLOTRIMAZOLE VAGINALTABLETS Anti-fungal agent 500mg

10 2016 TRIAMCINOLONEACETONIDE ORABASE

Syntheticcorticosteroid fortopical use

-

11 Pantoprazole Tablets Proton pump inhibitor(PPI) 20mg

12

ChlorpheniramineMaleate, Meclizine HCl,Caffeine Anhydrous,Pyridoxine HCl

Tablets Motion sickness

Chlorpheniramine 2mgMeclizine 25mgCaffine 20mgPyridoxine HCl 2mg

13 Calcium amino acidchelate, Vitamin D Tablets

Prevention of Calciumand Vitamin Ddeficiency

Calcium amino acid chelate 2000mgVitamin D 400IU

14 Ibuprofen 400mg/tab Tablets Relief of fever, painand inflammation 1200mg

15 Fluticasone propionate Nasal Spray Nasal steroid torelieve allergic rhinitis 200mcg

16 Mineral amino acid,cholecalciferol Tablets

Prevention of Calcium,Magnesium andVitamin D deficiency

Mineral amino acid 4000mgcholecalciferol 600IU

17 Exsiccated milk thistleextract + silymarin Tablets Liver protectant 450mg

18 Lactulose Liquid Relief of constipation 30g/ml

19 Fexofenadine Tablets Anti-histamine agent 120mg

20 Benzydamine HCl Oral sprayAnalgesic and anti-inflammatory agent forthe throat and mouth

Strength: 1.5mg/ml

21 Diethyltoluamide (DEET) Topicalsolution Repellent Strength: 120mg/ml

OTCswitched toQuasi Drug B

2017-2018

Country :Taiwan


No. AauthorizedYear

Ingredient Name DdosageForm Drug Efficacy Maximum Dose/Day Note

15

1 1999

Per tablet (4, 10 tablets):Aluminium Hydroxide 200-600 mg.Magnesium Hydroxide 200-400mg.

Oral tablet Gastrointestinal Adult: 4 tabletsChildren 2 tablets GSL

2 1999

Per 5 ml (240, 450 ml):Aluminium Hydroxide 165-650 mg.Magnesium Hydroxide 103-500mg.

Oral solution Gastrointestinal Adult: 20 mlChildren 10 ml GSL

3 1999Per tablet (4, 10 tablets):Sodium Bicarbonate 300 mg.Peppermint Oil 0.003 ml

Oral tablet Gastrointestinal Adult: 6 tabletsChildren 3 tablets GSL

4 1999

Per 15 ml (180, 240, 450 ml):Capsicum Tincture 0.060-0.500ml.Compound Cardamom Tincture0.035-1.800 ml.Strong Ginger Tincture 0.024-0.240 ml.


5 1999

Per 15 ml (180, 240, 450 ml):Sodium Bicarbonate 0.15-0.60 g.Compound Rhubarb Tincture 0.50-2.00 ml.and/ or other tinctures sunch as:Compound Cardamom Tincture 0.01-1.00 ml.Compound Gentian Tincture 0.18-1.10ml.Compound Tinospora Tincture 0.50ml.Weak Ginger Tincture 0.48-2.01 ml.Strong Ginger Tincture 0.10-0.30 ml.Nux Vomica Tincture 0.09-0.10 ml.Ipecacuanha Tincture 0.18-0.30 ml.and/ or other Volatile Substances sunchas:Peppermint Spirit 0.15-0.30 ml.Peppermint Oil 0.03-0.20 ml.Menthol 0.05-0.30 ml.Concentrated Dill Water 0.10 ml.Camphor 19.00 mg.


6 1999 Per 5 ml (60 ml):Sodium Bicarbonate 50 mg. Oral solution Gastrointestinal Adult: 15 ml

Children 10 ml GSL

7 1999 Asafetida 20 % w/v (15, 30, 60 ml) Topical Gastrointestinal Apply 3 times GSL

8 1999

One sachet (for 250 ml) :Sodium Chloride 0.875 g.Sodium Bicarbonate 0.625 g.Potassium Chloride 0.375 g.Glucose Anhydrous 5.000 g.orSodium Chloride 0.875 g.Trisodium Citrate Dihydrate 0.725 g.Potassium Chloride 0.375 g.Glucose Anhydrous 5.000 g.

Oral powder Anti-diarrheal (ORS) As required GSL

9 1999 Glycerin 91 % w/w per1.5 gram Suppository Anti-constipation As required GSL

10 1999 Glycerin 91 % w/w per 2.55 gram Suppository Anti-constipation As required GSL

11 1999 Per 15 ml (60, 120 ml):Magnesium Hydroxide 1.2 g Oral solution Anti-constipation Adult: 45 ml

Children: 30 ml GSL

12 1999Per tablet (4, 10 tablets):Sennosides eq. to Sennoside B 7.5mg

Oral tablet Anti-constipation Adult: 4 tabletsChildren 2 tablets GSL

Country: Thailand

Ingredients & Dosages Transferred From Dangerous/Non-dangerous drug (DD/NDD) into GSL (grocery medicine) Status

No. AauthorizedYear

Ingredient Name Ddosage Form Drug Efficacy Maximum Dose/Day Note

16

13 1999 Sodium Chloride 15 % w/v (10, 20 ml) Suppository Anti-constipation Adult: 40 mlChildren 20 ml GSL

14 1999 Mebendazole 100 mg Oral tablet Anti-parasite 1-2 tablets GSL

15 1999 Per tablet (4, 10 tablets):Paracetamol 500 mg Oral tablet Pain/ fever reliever

Adult: 2 tabletsChildren 1 tabletsevery 4-6 hr. (4 times max)Dosing is changed as of the 7thissue, 2017

GSL


Adult: 2 tabletsChildren 1 tabletsevery 4-6 hr. (5 times max)Dosing is changed as of the 7thissue, 2017

GSL

17 1999 Per 5 ml (30, 60 ml):Paracetamol 120 mg Oral solution Pain/ fever reliever

30 ml pack: 2.4 ml60 ml pack: 10 mlevery 4-6 hr. (5 times max) GSL

18 1999

Borneol 0.21-1.00 %w/wCamphor 1.00-2.80 %w/wCaoutchouc 30.00 %w/wEthylene Glycol Salicylate 2.00-6.00%w/wEucalyptus Oil 0.50 %w/wMenthol 0.30-6.49 %w/wMethyl Salicylate 0.14-6.00 %w/wPeppermint Oil 0.50-2.00 %w/wThymol 0.14-0.50 %w/wCapsaicin Extract 0.65 %w/wPolybutene 12.00 %w/wCapsicum Powder 11.00 %w/wCapsicum Oleoresin 3.00-11.00%w/wand/ or Zinc Oxide 14.00-22.00%w/w

Plaster Pain/ fever reliever 2 pads GSL

19 1999 Per tablet (4, 10 tablet):Chlorpheniramine Maleate 2 mg Oral tablet Anti-histamine Adult: 12 tablets

Children 6 tablets GSL

20 1999Per 5 ml (60, 120 ml):Ammonium Carbonate 0.02 g.Glycyrrhiza Fluidextract 0.25 ml.

Oral solution Anti-cough 10 ml 3-4 times GSL

21 1999

Per 5 ml (60 ml):Glycyrrhiza Fluidextract 0.6 ml.Antimony Potassium Tartrate 1.2-2.0 mg.Camphorated Opium Tincture 0.6ml.

Oral solution Anti-coughAdult: 10 mlChildren: 5 ml3-4 times

GSL

22 1999

Ammonium Carbonate 3.40%w/vStrong Ammonia Solution 3.60-6.75%v/v (15 ml)

Inhalant Dizziness, decongestant As required GSL

Country: Thailand

Ingredients & Dosages Transferred From Dangerous/Non-dangerous drug (DD/NDD) into GSL (grocery medicine) Status No. Aauthorized


17

23 1999

Menthol 0.07-77.90 %w/vCamphor 0.45-42.00 %w/vMethyl Salicylate 3.00-15.00 %w/vAnise Oil 0.68 %v/vBurgamot Oil 0.50-0.68 %v/vCajuput Oil 0.50-11.00 %v/vCassia Oil 0.50 %w/vClove Oil 1.25 %v/vDwarf-Pine Needle Oil 1.00 %w/vEucalyptus Oil 1.50-23.00 %v/vLavender Oil 4.69-8.00 %v/vPeppermint Oil 2.20-10.38 %v/vSage Oil 6.00 %w/vSassafras Oil 5.00 %w/vTurpentine Oil 0.71-8.00 %w/vCapsicum Tincture 4.00-8.00 %v/vMyrrh Tincture 1.00 %w/vRatanghia Tincture 0.40 %v/vTerpinol 3.33 %v/vThymol 0.10 %w/vCamphor Spirit 3.00 %v/vBorneo Camphor 9.00 %w/vBornyl Acetate 0.42 %w/vLinalyl Acetate 0.47 %w/vPhenyl Salicylate 0.60 %w/vStandard Chamomile Extract 10.00%w/v(Not more than 14 ml)

Inhalant Dizziness, decongestant As required GSL

24 1999

Menthol 1.35-3.00 %w/w Camphor 3.00-9.00 %w/w Cajuput Oil 3.00 %w/w Eucualyptus Oil 0.08-5.00 %w/w Terpentine Oil 4.68-5.00 %w/w(Not more than 50 gram)

Topical Dizziness, decongestant As required GSL

25 1999 Per tablet (2 tablets):Dimenhydrinate 50 mg. Oral tablet Dizziness 1 tablet GSL

26 1999 Sulfacetamide Sodium 10 %w/v (10 ml) Eye drop Eye infection 2 drops 3-4 times GSL

27 1999

Sodium Chloride pack not more than240 ml (Isotonic, pH6-8 withBenzalkonium chloride 0.002-0.020%w/v or Chlorhexidine (Gluconate/Acetate) 0.01 %w/v as preservative)

Eye solution Eye irrigation 3 times GSL

28 1999

15 ml contain:Potassium lodide 2.50 g. Iodine 1.25 g. Ethyl Alcohol (90 percent) 4.00 ml. Purified Water 2.50 ml. Peppermint Oil 0.40 ml. Glycerin to 100.00 ml.

Topical Astringent As required GSL

29 1999 Gentian Violet 1 %w/v (15, 30 ml) Topical Astringent As required GSL

30 19998 ml contain:Chlorobutanol 25 g.Clove Oil to 100 ml.

Topical Toochache As required GSL

Country: Thailand



18

31 1999

Abietis Pine Oil 0.30 %v/wAnise Oil 0.25 %w/wBorneol 1.66-2.00 %w/wCinnamon Oil 0.35 %w/wCreosote 0.20 %v/wEucalyptus Oil 0.15-0.16 %w/wLemon Oil 0.30-0.52 %v/wMenthol 0.06-5.00 %w/wPeppermint Oil 0.19-3.33 %w/wSylvestris Pine Oil 0.30 %v/wLicorice Extract 7.31-16.67 %w/wTincture Capsicum 0.02 %w/wAmomum 1.00-4.00 %w/wAniseed 2.00 %w/wCatechu 8.33-38.00 %w/wCinnamon 2.00-10.00 %w/wClove 0.67-4.00 %w/w Costus 0.67 %w/w Fennel 1.67-2.00 %w/w Ginger 2.00-8.00 %w/w Licorice 26.67-71.38 %w/w Saffron 2.00 %w/w Saussurea 1.00-3.00 %w/w Silver Leaf 0.93 %w/wand/ or Honey 1.50-2.40 %w/w(100 tablets or not more than 30 gram)

Lozenge Throat irritation 5 tablets GSL

32 1999Iodine 2.0-2.5 %w/vPotassium Iodide 2.4-2.5 %w/v(15, 30 ml)

Topical Wound dressing As required GSL

33 1999 Thimerosal 0.1 % w/v (15, 30 ml) Topical Wound dressing As required GSL

34 1999Povidone-lodine 10 % w/vEqivalent to lodine 1 % w/v(not more than 120 ml)

Topical Wound dressing As required GSL

35 1999 Isopropyl Alcohol Solution 70 % v/v(not more than 450 ml) Topical Wound dressing As required GSL

36 1999 Ethyl Alcohol Solution 70 % v/v (notmore than 450 ml) Topical Wound dressing As required GSL

37 1999 Sodium Chloride 0.9 % w/v (notmore than 1000 ml) Topical Wound irrigation As required GSL

38 1999Silver Sulfadiazine 1 % w/w (5, 15,25 gram)Switch back to Rx (6thissue, 2017)

Topical Burns As required GSL

39 1999

Methyl Salicylate 1.14-50.00 %w/wCamphor 1.76-25.00 %w/wMenthol 3.00-20.00 %w/wCinnamon Oil 1.00-2.40 %w/wClove Oil 0.50-5.00 %v/wEucalyptus Oil 1.50-13.70 %v/wPeppermint Oil 0.70-16.00 %w/wTerpentine Oil 2.00-3.80 %v/wCapsicum Tincture 0.80-8.00 %v/vColophony 2.51 %v/w(not more than 30 gram)

Topical Sting/ pain As required GSL

40 1999 Benzyl Benzoate 25 % w/v (30, 60ml) Topical Scabies/ Louse As required GSL

41 1999 Sublimed Sulphur 10 %w/w (5, 15gram) Topical Scabies As required GSL

Country: Thailand



19

42 1999Benzoic Acid 2.5-6.5 % w/wSalicylic Acid 3.0-5.0 % w/w(5, 15 g)

Topical Ringworm As required GSL

43 1999 Coal Tar 1 % w/w (5, 15 gram) Topical Skin reaction As required GSL

44 1999Calamine 8-15 % w/vZinc Oxide 3-12 % w/v(not more than 180 ml)

Topical Skin rash As required GSL

45 1999 Sodium Thiosulfate 100 % w/w (15g for 60 ml solution) Topical Ringworm As required GSL

46 1999

Per tablet (4, 10 tablets):Thiamine Hydrochloride or ThiamineMononitrate 5 mg.Pyridoxine Hydrochloride 2 mg.Riboflavine 2 mg.Nicotinamide 20 mg.

Oral tablet Supplement Adult: 2 tabletsChildren: 1 tablet GSL

47 1999 Per tablet (4, 10 tablets):Ascorbic Acid 100 mg. Oral tablet Supplement Adult: 2 tablets

Children: 1 tablet GSL

48 1999Per tablet (4, 10 tablets):Ferrous Sulfate Equivalent to Iron60 mg.

Oral tablet Supplement Adult: 2 tablets3 times GSL

49 1999

Per tablet (4, 10 tablets):Vitamin A 2,500 I.U.Vitamin D 300 I.U.Vitamin C 15.00 mg.Vitamin B1 Monoitrate 1.00 mg.Vitamin B2 0.50 mg.Nicotinamide 7.50 mg.

Oral tablet Supplement Adult: 1 tablet GSL

50 1999

Per tablet (4, 10 tablets):Cod Liver Oil equivalent toVitamin A not more than 4,000 IU.Vitamin D not more than 300 IU.

Oral tablet Supplement Adult: 1 tablet GSL

51 1999

Per 5 ml (120, 240, 400 ml):Cod Liver Oil equivalent toVitamin A not more than 4,000 IU.Vitamin D not more than 300 IU.

Oral solution Supplement 5 ml GSL

52 2006

Amyl metacresol not more than 0.6mg.2,4 Dichloro Benzyl Alcohol notmore than 1.2 mg.or with Ascorbic acid not more than100 mg.(8 tablets)

Lozenge Throat irritation every 2-3 hours GSL

53 2012

Per tablet (4, 10 tablets):Aluminium Hydroxide 200-600 mgMagnesium Hydroxide 200-400 mgSimethicone 40-125 mg

Oral tablet Gastrointestinal Adult: 4 tabletsChildren: 2 tablets GSL

54 2012

Per 5 ml (240, 450 ml):Aluminium Hydroxide 165-650 mgMagnesium Hydroxide 103-500 mgSimethicone 20-40 mg

Oral solution Gastrointestinal Adult: 20 mlChildren: 10 ml GSL

Country: Thailand



20

55 2012

Per sachet (4.3 g):Citric Acid Anhydrous not more than1.850 g.Sodium Bicarbonate not more than1.960 g.Sodium Carbonate not more than0.430 g.

Oral powder Gastrointestinal 1 sachet every 2-3 hours GSL

56 2012 Per tablet (10 tablets):Activated charcoal 250-350 mg Oral tablet Anti-diarrheal 16 tablets GSL

57 2012Chloroxylenol 4.8 % w/vIsopropyl Alcohol Solution 12 % v/v(450 ml)

Topical Wound disinfectant As required GSL

58 2012

One sachet (for 250 ml) :Sodium Chloride 0.650 g.Trisodium Citrate Dihydrate 0.725 g.Potassium Chloride 0.375 g.Glucose Anhydrous 3.375 g.

Oral powder Anti-diarrheal (ORS) As required GSL

59 2012Per tablet/ capsule (10tablets/capsules):Simethicone 40 mg

Oral tablet/ Capsule Gastrointestinal 12 tablets GSL

60 2012Per tablet/ capsule (10tablets/capsules):Simethicone 80 mg

Oral tablet/ Capsule Gastrointestinal 6 tablets GSL


Depending on weight:< 34 kg: Consult physician orphamacist before using34-50 kg: 1 tablet every 4 hoursas needed50-67 kg: 1.5 tablet every 4hours as needed (5 times max)> 67 kg: 2 tablet every 4 hours asneeded (4 times max)

GSL


Depending on weight:22-33 kg: 1 tablet every 4 hoursas needed33-44 kg: 1.5 tablet every 4hours as needed> 44 kg: 2 tablet every 4 hours asneeded

GSL

63 2017 Per 5 ml (30, 60 ml):Paracetamol 120 mg Oral solution Pain/ fever reliever

For infant (Age <2 months):Consult physician before using

For infant/child (Age 2 monthsand above):4-6 kg: 2.5 ml every 4 hours asneeded (5 times max)6-8 kg: 3.75 ml every 4 hours asneeded (5 times max)8-12 kg: 5 ml every 4 hours asneeded (5 times max)12-16 kg: 7.5 ml every 4 hours asneeded (5 times max)16-24 kg: 10 ml every 4 hours asneeded (5 times max)

GSL

64 2018

Per tablet (not more than 20 tablets):Sodium Alginate 250 - 500 mgSodium Bicarbonate 95 - 300 mgCalcium Carbonate 70 - 360 mg

Oral tablet acid reflux relief, withantacid benefit

12 years and above: 2-4 tablets,4 times/day GSL

65 2018

Per 10 ml (not more than 150 ml):Sodium Alginate 250 - 500 mgSodium Bicarbonate 95 - 300 mgCalcium Carbonate 70 - 360 mg

Oral Suspension acid reflux relief, withantacid benefit

12 years and above: 10-20 ml, 4times/day GSL

Country: Thailand



21

1 2018 Per gumNicotine 2 mg and 4 mg

Chewing gum smoking cessation

As required (12 times max)1-19 cigarrettes using: 2 mgchewing gum> 20 cigarrettes using: 4 mgchewing gum

NDD

2 2018 Per patchNicotine 7 mg, 14 mg and 21 mg

Transdermal patch smoking cessation

As required (1 patch/24 h)1-20 cigarrettes using: 14 mgpatch, 7 mg patch> 20 cigarrettes using: 21 mgpatch, 14 mg patch, 7 mg patch

NDD

3 2019Per tablet (10 tablets/strip, notmore than 2 strip/box)Loratadine 10 mg

Oral tablets/capsules allergic conditions 12 years and above: 1 tablet/day NDD

Country: Thailand

Ingredients & Dosages Transferred From Rx /Dangerous Drug (DD)-to-NDD (pharmacy medicines, advertisable) Status No. Aauthorized


22

Annex 3: New and Amended Regulation from 2016 to 2019 in Member Countries

23

Country China

Year Month Regulation Name N/A Note

3

Report on the work of the govermnet in "Twosessions" of 2014: Emphersized market functionfrom 'basic‘ into 'crucial'. N

3 "Bad record" policy : The company in "Badrecord" will been restricted in sales and bidding. N

5

Low-price drug policy & list: The highest retailprice will be abolished which daily treatment costunder 3 yuan (chemical medicine) and 5 yuan(Chinese patent medicine), the actual trade pricewill be determined by market, it 's good for someOTC.

N

10

Interim regulation on enterprise informationbulletin : Disclosing administrative punishmentinformation will damage enterprises' reputation. N

3

Public hospital drug bidding purchasing workguidance : Implement classification ofprocurement, common low price drug willpurchase via internet by hospitals directly.

N

4

Advertisement law : Medical precursor chemicalswill be forbidden from public advertisement,Medical advertisements can't be recommendedand proved by anybody.

N

5

Reform of drug prices : Apart from narcotic drugsand the first psychotropic substances, the prices ofother drugs have been abolished since June 1,2015

N

9

Reforming Drugs & Medical Devices Review &Approval System : Pilot License-holdermechanism of Drugs Launch. Simplified andimproved examination and approval proceduresover drugs(including clinical trial test) and medicaldevices.

N

11

13th five-years planning suggestion : Encouragethe social capital engagement in medical field,private hospitals will become the sales growthpoint in future.

N

2014

2015

24

3

Consistency evaluation of generic drugs : Requiregeneric drugs conduct consistency evaluation,products which pass the evaluation have potentialthreat to high quality originals.

N

4

Double invoice system : Only allow two invoicethrough the drug circulation, one is frommanufacturer to distributor, another is fromdistributor to hospital.

N

4

Reimbursement payment standardguidance(exposure draft) : For those drugs withtheir payment standard formulated according todifferent companies, the sale prices in pharmaciesshould not exceed the standard.

A

7

Precursor chemicals administrationregulation(exposure draft) : PSE compoundpreparations enter into the special monitoring list. A

7

GSP : Delete the relevant provisions of theelectronic supervision, increase the establishmentof drug traceability system. N

2016

25

2

国�院于印�“十三五”国家食品安全<�和“十三五”国家9品安全<�的通知：保障9品安全，提高9品B量安全水平。The State Council’s Notification regardingIssuance of National Food Safety Planning andNational Drug Safety Planning for the ‘13th Five-Year Plan’ Period ：Assurance of drug safety andimprovement of the drug quality and safety.

N

4

《国家食品9品3督管理&局于A整部分9品行政�批事I�批程序的决定》（国家食品9品3督管理&局令第31号） (2017-04-05). �C一-加%9品注册管理，切�提高�>�批效率，将下列由国家食品9品3督管理&局作出的9品行政�批决定，A整�由国家食品9品3督管理&局9品�>中心��床?J�批，9品:充�批，C口9品再注册�批决定，其他9品注册申@由CFDA作出决定。CFDA Published Adjustment of Decision-makingProcedures for Administrative ApprovalItems(2017-04-05)In order to further strengthen drug registrationmanagement and effectively improve the efficiencyof review and approval. The State Council of Foodand Drug Administration decided to adjust thefollowing administrative approvals forpharmaceuticals made by the State Food andDrug Administration to be approved by the StateFood and Drug Administration's Drug EvaluationCenter for clinical trial approval, drug supplementapproval, and import. The drug renewal approvaldecision, other drug registration applications aredecided by the CFDA.

N

5

��F ��.��9�0��*H2017"E/!��2D4K1.��)C�18��$=�� 2(�';。2.��*H��579��#�G,�2�+';。66The State Council’s Notification regarding keypoint of work in 2017 on deepening reform of themedical and health care systemsK1 promote thebuilding and development of medical consortia 2reform and improve the mechanism for ensuringthe supply of drugs in short supply. and so on.

N

2017

26

8

�局�于推'�品上市!可持有人制度#点工作有�事+的通知 (2017-08-21) ，�加快推'持有人制度#点工作，'一�探索持有人的�利�和法律$任、委托生�中的%量管理体系和生�)售全(条的$任体系、跨区域�品�管机��管�接、�$�分以及$任落地等事宜'行了具体�$要求通知。CFDA notice on promoting Pilot Program of DrugRegistrant System(2017-08-21). In order toaccelerate the pilot work of the holder system, thecompany further explores the rights and obligationsand legal responsibilities of the holders, the qualitymanagement system in the production and theresponsibility system for the production and saleschain. The cross-regional drug regulatory agencies'supervision and connection, division ofresponsibilities, and responsibility landings werenotified of specific responsibilities.

N

10

中共中央公� 国院公�印�《�于深化�"�批制度改革鼓励�品医�器械�新的意》：一、改革�床#,管理,二、加快上市�"�批,三、促'�品�新和�制��展,四、加��品医�器械全生命周期管理,五、提升技�支�能力,六、加�� 施General Office of the Communist Party of Chinaand General Office of the State Council Printingand Distributing “the Opinion on Deepening theReform of the Review and Approval System andEncouraging the Innovation of Drugs and MedicalDevices”：1. Reform the management of clinicaltrials. 2. Accelerate evaluation and approval. 3.Promoting drug innovation and Generic drugdevelopment; 4. Strengthen full life cycleadministration on drug and medical device; 5.Promoting technology supporting capability;6.strengthen organization implementation

N

11

�� (2017-11-21) �加��品生�的�督管理制定本法，食品�品�督管理部*依法��品生�条件和生�&程'行��、!可、�督��。Drug Manufacturing and Administrative regulation(2017-11-21). In order to strengthen the supervisionand management of pharmaceutical production, themanagement activities of the food and drugsupervision and administration department toreview, permit, supervise and inspect theproduction conditions and production processes ofdrugs.

N

2017

27

11

�� (2017-11-21) �加��品��!可工作的�督管理制定本法，国家食品�品�督管理�局主管全国�品��!可的�督管理工作，明�了�品批�企�理《�品��!可"》�"、�"、�更的程序及要求。Drug business license Administrition(2017-11-21) .In order to strengthen the supervision andmanagement of drug business license work. TheState Food and Drug Administration is in charge ofthe supervision and administration of the nationaldrug business license, and clarifies the proceduresand requirements for the drug wholesaleenterprises to handle the issuance, renewal andchange of the Drug Business License.

11

�� (2017-11-21) . �加��品�督管理，范互�网�品信息服�活�，保"互�网�品信息的真�、准�，根据《中人民共和国�品管理法》《互�网信息服�管理法》, 制定互�网�品信息服�%格�管，明�了按照属地�管原�的申�要求。Drug internet information serviceadministartion(2017-11-21). In order to strengthendrug supervision and management, standardizeInternet drug information service activities, andensure the authenticity and accuracy of Internetdrug information, according to the "People'sRepublic of China Drug Administration Law" and"Internet Information Service administration", theestablishment of Internet drug information servicequalification supervision, clearly in accordancewith Declaration requirements for territorialsupervision principles.

12

�局�于鼓励�品新�行�先�#�批的意�(2017-12-28): �加��品注册管理，加快具有�床价�的新�和�床急需�制�的研�上市，解决�品注册申$��的矛盾，提出�先�#�批的范�，程序及工作要求。In order to strengthen drug registrationmanagement, speed up the research anddevelopment of clinically valuable new drugs andclinically urgently needed generic drugs, andresolve the contradiction of backlog of drugregistration applications, the scope, proceduresand work requirements for priority review andapproval are proposed. (2017-12-28)

N

2017

28

7

国家s品b督管理局%布接受s品境外�床y�数据的技R指9原�：�用于指9s品在中!人民共和国境内申D注册L，接受申z人采用境外�床y�数据作��床x价�料的工作。Technical Guidelines for Acceptance of OverseasDrug Clinical Trial Data：These guidelines apply tothe acceptance of adopting overseas clinical trialdata as clinical evaluation data in drug registrationapplications within the territory of the People’sRepublic of China.

N

10

,71Qs[d@�2018;Z�:N-2012;Zd@1f��t{J4)��N2�(gI��^$Sa520g2��685g�N��kT��N��Wwr�/、wU�*Nlm.G�us<��2��p�Xr+�vcP3� �=`�。�N?��=A�National list of essential medicines(2018 edition) : is based on the 2012 version ofthe directory to adjust, 1) to increase the numberof varieties, increased from 520 to 685, 2) tooptimize the structure 3)to further standardize thetypes, specifications, 4) continue both on Chineseand western medicine, increased the functionrange of the attending, cover more TCM clinicalsymptoms. 5) strengthens the clinical necessity

A

�� 1

,��#��"%,7ijs(��~'�]yYKVa�e��F11�0:� ��}�'_H�qBx�a��s8>a�]&s(��yY(g�,7ijs(��~'�]yY�5\s�MO��Cns�|EhhNotice ofthe general office of the state council on theissuance of pilot programs for centralizedprocurement and use of drugs organized by thestate�11 cities were selected to select the pilotvarieties from generic drugs corresponding togeneric drugs that have passed the consistencyevaluation of quality and efficacy. The stateorganized the centralized procurement and usepilot of drugs, so as to achieve a significantreduction in drug prices and reduce the burden ofdrug costs on patients

N

7

国家sb局�于�一W完善s品�o6x6批和b管工作有�事宜的公告（2019年第56号）NMPA's Announcement on Further Improvementof Bundling Evaluation and Approval forPharmaceutical, Pharmaceutical PackagingMaterials and Pharmaceutical Excipients, and alsothe Related Regulatory Work (No.56, 2019)

N

2018

29

7

国家��局�于宣��《中�人民共和国疫苗管理法》的通知 (2019-07-30) 。《中�人民共和国疫苗管理法》于2019年6月29日由第十三届全国人民代表大会常�委会第十一次会��通�，自2019年12月1日起施行。CFDA notice regarding Vaccine AdministrationLaw of People's Republic of China (2019-07-30).The "Vaccine Administration Law of the People'sRepublic of China" was reviewed and approved bythe 11th meeting of the Standing Committee of the13th National People's Congress on June 29,2019, and will take effect on December 1, 2019.

N

8

中�人民共和国�品管理法：自1984年!布以来的第二次系�性、��性的重大修改，将�品"域改革成果和行之有效的做法上升�法律，�公�健康提供更有力的法治保障。the drug administration law of People's Republic ofChina will be implemented on 1st Dec 2019. Thisis the second major systemic and structural reformsince its promulgation in 1984, which hastranslated the achievements and effectivepractices of drug reform into law and providedstronger legal protection for public health.

A

8

国家��局�于印�品�量抽��#管理�法的通知：自2006年，��13年之后，�加 �品�督管理，�范�品�量抽��#工作，��修�了本法。用于在中�人民共和国境内依批准生�、��、使用�品�展的�量抽��#工作。NMPA notification on Measures for theadministration of spot check and inspection ofdrug quality: since 2006, after 13 years, This lawhas been revised to strengthen drug supervisionand control and to regulate the random inspectionand testing of drug quality. It is applicable to thequality sampling inspection of drugs produced,sold and used in accordance with the approvalwithin the territory of the People's Republic ofChina

A

��

30

Country Indonesia INDONESIA

NADFCNo. YEAR REGULATION NAME

NOTE

25 2017 Procedure for Certification of Good DistributionPractices

New

24 2017 Criteria and Procedure for Drug Registration Amendment

8 2017 Drug Advertising Guidelines Amendment

4 2017Control of Drug and Food Imports into IndonesianTerritory

Amendment

34 2018Guidelines for Good Manufacturing Practises(GMP)

Amendment

33 2018 Implementation of 2D Barcodes in Drug and FoodControl

26 2018Integration of Electronic Licensing Service ofDrug and Food Sector

New

4 2018

Control the Management of Drugs, Drug RawMaterials, Narcotics, Psychotropics, andPharmaceutical Precursors in PharmaceuticalServices Facilities

Amendment

15 2019Amendment to the Regulation of the NADFCNumber 24/ 2017 Regarding Criteria andProcedure for Drug Registration

Amendment

14 2019

Amendments to Drugs Withdrawal andElimination Drugs that Do Not Meet Safety,Efficacy, Quality and Label Standards and / orRequirements

Amendment

10 2019 Guidelines for the Management of Certain Drugsthat are Often Abused

Amendment

9 2019 Technical Guidelines for Good DistributionPractises (GDP)

Amendment

7 2019Evaluation of Fulfillment of Requirements forGood Manufacturing Practises for Imported DrugManufacturing Facilities

New

List of New Regulation and Amended Regulation from 2017 to 2019

Country

31

Country Japan Japan

N:NewA:Amend


3

Notice No. Yakuseishinsahatasu0325-10 on 25 March, 2016

A

With the review of ethical medicinescontaining Lysozyme hydrochloride,the registration for the OTC coldremedies or antitussives andexpectorants were terminated.

4

New consultation body "Review boardfor the reclassification of ethicalmedicines to OTC medicines" wasestablished.

N

It was aimed to build up the reflectingscheme to accept timely on thereclassification trends in abroad andrequest for the assessment from thevarious stakeholders includingconsumers and academia, and to becontributed in the decision for thereclassification in the MHLW.

6

Notice: Yakuseihatsu 0626-3"On the Function of General Managerfor manufacturing and Marketing,Executive Quality Manager, andExecutive Safety Manager"

A

Based on the incidents where the threemajor responsible officers in marketingauthorization holders did not fulfill theirexpected responsibilities, the MHLWinstructed drug firms to ensure theirproper functioning.

7

Notice: Yakuseianhatsu 0704-2"Revising the use instruction of drugscontaining codeine phospate ordihydrocodeine phosphate"

N

Based on the safety evaluation, MHLWindtructed the manufacturers of drugscontaining the said ingredients (Rx orOTC) to do the following;(a) an immediate revision of thelabelling so that the drug should not beused for children under age 12.(b) within 18 months, a change of theingredients to eliminate codeinesshould be made or the products shouldindicate that it is not for children(c) in 18 months the products shouldbe conttra-indicated for children underage 12.

9Notice: Yakuseihatsu 0929-4"Revision of Drug AdvertisementStandard"

A The standard for advertising drugsunderwent a major revision.

3 Japanese Pharmaceutical Excipients2018 N

The standars underwent a majorrevision. The standards containspecifications of 489 excioients.

12 Extra-pharmacopoeia HerbalMedicine Standards 2018 N

The standars underwent a majorrevision. The standards containspecifications of 83 herbal medicines.

2017

2018


Country

2016

32

Country Korea Korea

2016 Oct Regulation on pharmaceuticals approval,notification and review

A

If a new OTC product is satisfy following conditions,comparative clinical data or bioequivalence data isnot required;1) only the dosage form is modified from oral solidform to orally integrating tablet (or film)2) all ingredients and specs are proper to OTCmonograph3) it is proved that the ingredients are not absorbedorally

2017 Dec OTC monograph A"Lysozyme HCl" was deleted from OTC monograph

2018 Nov Regulation on pharmaceuticals approval,notification and review

A

<Required data list for approval of OTC products>caluse addedFormer regulation was listing required data on bothETC & OTC products without distinction, with thisrevise, regulation on OTC products are separated

Country


33

Country Philippines Philippines

N:NewA:Amend


2

FC2014-008 Application Process andRequirement for Post-ApprovalChanges of Pharmaceutical Products

N

3FA 2014-016 Review of Guidelines forOTC Drugs N

4

FC2014-011 Application Process andRequirement for Post-ApprovalChanges of Pharmaceutical Products

A

11

FC2014-026 Guidelines on theImplementation of New Rules andRegulations on the Licensing of DrugDistributors

N

11

FC2014-028 Guidelines on theImplementation of New Rules andRegulations on the Retail Outlets forNon-Prescription Drugs

N

10FC2014-034 Rules and Regulationson the Licensing of Estalishments N

2015 12

AO 2015-0053 ImplementingGuidelines on the Promotion andMarketing of PharmaceuticalProducts

N

3

AO2016-008 Revised Rules andRegulations Governing GenericLabelling Requirements

A

5FC2016-004 e-License To OperateApplication N

10FC2016-017 Addition Post ApprovalChanges for Pharma Products N

2018 10

FC 2018-014 Validity of Registrationof Pilot Products under Review ofOTC Applications N

2014

2016


Country

34

Country Taiwan Taiwan

N:NewA:Amend


JanRevision on format and submission timing of periodicsafety update report required in Regulations for DrugSafety Monitoring for new medicines and other cases

A

Jan Guideline of judgement on combination drugs N

FebAnnouncement of the implemention items and schedulefor Western Drug PIC/S GMP Guide Part III: GDP N

MarGuideline of labeling format and QR code on productpackaging material for non-prescription drug N

Mar Revision of Pharmaceutical Stability Testing Benchmark A

AprRevision of Regulations for Registration of MedicinalProducts (mainly for API GMP and source, repackingsite registering and etc.)

A

Jan Announcement of Refuse to File (RTF) implementationfor Generic Drug Registration submission review

N

AugAnnouncement of the Clinical Benefit and Risk Re-assessment for codeine containing product used inchildren

N

Sep Revision of Western Drug PIC/S GMP Guide Part I AThe update is mainly for articles in Chapter 1 PharmaceuticalQuality System, Chapter 2 Personnel, Chapter 6 QualityControl and Chapter 7 Outsourced Activities

Nov Announcement of implementation of Switch submissionrequirement checklist

N

Dec Revision of Regulations for Registration of MedicinalProducts

A The update is mainly for articles related to package e-fileuploading requirements, API document requirements, and etc.

DecAnnouncement of the establishement of GoodDistribution Practice guideline for Western Drug N

MayAnnouncement of the applicable drug and substituteddocument type for DMF requirement exemption in theRegulations for Registration of Medicinal Products

N

For Non-prescription drugs which are not new chemicalentities or under new drug surveillance and whose API sourcecomplies with GMP, the submission of an outline ofsynthesis route / manufacturing process, testingspecifications, methods and results of active ingredients cansubstitute the full DMF requirement

Sep Announcement of implementation mechanism andtimeline of Good Distribution Practice for Western Drug

N

Oct Revision of Guidelines on the Review of Over-The-Counter (OTC) Drug (OTC Monograph)

A

The update is mainly for the new introduction of TopicalAntiseptic and Antimicrobial drug products, Topical Antifungaldrug products, Topical Antipruritic and anti-inflammatory drugproducts, Topical Acne drug products, Diaper rash andantimiliaria drug products, and Dry skin and exfoliation drugproducts and minor update of the remaining existingmonographes

FebRevision of Regulations for Registration of MedicinalProducts A

The update is mainly for articles related to e-submissionmanagement, Advanced 10 country CPP legalizationexemption, expiration dating format, and etc.

May Revision of Western Drug PIC/S GMP Guide Part I AThe update is mainly for articles in Chapter 3 Premises andEquipment, Chapter 5 Production, and Chapter 8 Complaintsand Product Recall

Jul Announcement of implementation of Patent linkage forWestern Drug

N

Jul Refuse to File (RTF) checklist for Generic DrugRegistration submission review

A The update is mainly for the addition of patent link declarationsections

Jul Revision of Regulations Governing the Trace and TrackSystem for Medicinal Products

A Medicine containing ephedrine or pseudoephedrine(excluding controlled drug) is new item in scope

AugRevision of Guidelines on the Review of Over-The-Counter (OTC) Drug (OTC Monograph) A

The update is mainly for the new introduction of Nasal drugproducts and Topical hemorrhoidal drug products and minorupdate of the remaining existing monographes

AugAnnouncement of Refuse to File (RTF) implementationfor New Drug and Biological Drug Registrationsubmission review

N

2018

2019


Country

2016

2017

35

Country Thailand Thailand

N:NewA:Amend


26-Feb

Reclassification Guideline for DossierPreparation and Evaluation Criteria onreclassification of Human ModernMedicines(Food and Drug AdministrationAnnouncement)

N

Applicable for reclassification for: 1)Dangerous medicines, 2) Speciallycontrolled medicines 3) non-dangerous/non-specially controlledmedicines and 4) Household Remedymedicines

27-May

Guideline, criteria and conditions forjustification of Good PharmacyPractice (Food and DrugAdministration) N

Mandatory for Selling drug license,Wholesale selling drug license, Sellingdrug license for non-dangerous andnon-specially controlled medicines inpre-package, Selling drug license forveterinary drug in pre-package

Revised Drug Act BE 2510 (version 6),

License renewal (every 7 years)

A

License renewal (every 7 years) –under the old version of Drug Act, allmedicine licenses granted by ThailandFDA is life-long validity (unless notmanufacturing/ importing continuouslyfor 2 years). With this, all licenses willneed to renew & submit technicaldocuments for review (e.g. qualitysection, esp stability, specificationetc.). License renewal dossier &process guideline is being drafted byThailand FDA and expected to publishby end 2019 at earliest time. The firstbatch of licenses to be renewed will bein next 5 years (Yr 2024).

Revised Drug Act BE 2510 (version 6)

License re-evaluation

A

FDA introduce this process formally inthe Drug Act (Rev 6), allowing thereview of quality, safety, efficacy ofproducts & suitability as medicines.Upon the license re-evaluation, theoutcome could be the withdrawal oflicense, label modification, dosageadjustment etc. depending on the risklevel. License re-evaluation dossier &process guideline is being drafted byThailand FDA and expected to publishby end 2019 at earliest time. Thelicense re-evaluation could take placeanytime and initiated by FDA or anystakeholder.


Country

2016

2019

36

summary of apsmi country report 2019 · medication in apsmi member countries; i.e. china, chinese...

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