briefing on tbs training course 18 sep 2006 geneva 1 dr xiaorui zhang coordinator traditional...

Briefing on TBS Training course 18 Sep 2006 Geneva

11

Dr Xiaorui ZhangDr Xiaorui ZhangCoordinatorCoordinator

Traditional MedicineTraditional MedicineDepartment of Essential Drugs and Traditional MedicineDepartment of Essential Drugs and Traditional Medicine

World Health OrganizationWorld Health Organization

International Regulatory Cooperation on International Regulatory Cooperation on Proper Use of Traditional MedicineProper Use of Traditional Medicine


22

Populations using TM/CAM worldwidePopulations using TM/CAM worldwide

Populations using traditional medicine for primary health care

60%

60%

70%

70%

70%

90%Ethiopia

Benin

India

Rwanda

Tanzania

Uganda

Populations in developed countries who have used complementary and alternative medicine at least once

42%

48%

49%

70%

80%

Canada

Australia

France

USA

Sources: Eisenberg DM et al. 1998; Fisher P & Ward A, 1994; Health Canada, 2001;World Health Organization, 1998; and government reports submitted to WHO.

Germany


33

Germany & France dominate onEuropean herbals market

6%

5%

4%

11%2%2%2%

8% 21%

39%

GERMANY

FRANCE

ITALY

POLAND

UK

SPAIN

SWITZERLAND

BELGIUM

NETHERLANDS

OTHERS

Source: IMS 2005

Total Market 09/2003-09/2004: ~ 3.7 billion € ex-factory


44

TCMs (Preparations & TCMs (Preparations & Processed Products)Processed Products)

- RMB 84.9 billion (USD 10.3 - RMB 84.9 billion (USD 10.3 billion)billion)

Western Medicines Western Medicines - RMB 144.6 billion (USD - RMB 144.6 billion (USD 17.6 billion) 17.6 billion)

37%

63%

TCM Western Medi ci nes

Annual Sales Comparison between Traditional Chinese Medicines and Western Medicine

Herbal Market in China (2004)


55

Projected Worldwide Growth of Herbal Projected Worldwide Growth of Herbal Remedies Until 2006Remedies Until 2006

0.0

5.0

10.0

15.0

20.0

25.0

30.0

2000 2001 2002 2003 2004 2005 2006

Sports/ Specialty Herbals VMS

Sou

rces:

Ph

yto

ph

arm

Con

sult

ing

, D

ata

mon

itor

+ 3.2%/a

+ 2.4%/a

+ 8.5%/a


66

Traditional medicine contribute to health

Artemisinin is a new anti-malarial drug. It was discovered from Artemisia annua L. which is traditionally used Chinese medicine for treatment of malaria and other health problems. WHO recommends to use Artemisinin based combined therapy (ACT) for the treatment of falciparum malaria since 2002Currently, Tamiflu is the only drug for avian influenza. It is based on shikimic acid which is abstracted from plant Illicium lanceolalum, which is also one of traditionally used Chinese medicines


77

Difficulties Specific to TM/CAM Research

Characteristics of Western MedicineCharacteristics of Western Medicine

The main philosophy of Western The main philosophy of Western Medicine is that if the human body is Medicine is that if the human body is struck by diseases, the causative agent struck by diseases, the causative agent must be identified and dealt with in must be identified and dealt with in order to return patients to a state of order to return patients to a state of good health. good health.


88

Difficulties Specific to TM/CAM Research

A common feature of most systems of Traditional A common feature of most systems of Traditional Medicine is that they take a 'holistic' approach towards Medicine is that they take a 'holistic' approach towards the sick individual and treat disturbances on the the sick individual and treat disturbances on the physical, emotional, mental and living environment physical, emotional, mental and living environment levels simultaneously.levels simultaneously.


99

Duration: at least 13 yearsCost: at least US$ 100 million

Procedure for developing a new chemical drug


1010

Reported by Prof Yeeng -chi Cheng, Reported by Prof Yeeng -chi Cheng, Yale Medical School 2001Yale Medical School 2001

The combination of 4 plants creates powerful synergy for maximum anti-tumour effect

Evaluation of Efficacy of Herbal MedicinesEvaluation of Efficacy of Herbal Medicines

Removing any one of the 4 plants weakens the effectiveness of the formula


1111

WHO Traditional Medicine Strategy 2002-2005

integrate TM/CAM

with national health care systems

provide evaluation, guidance and support for effective regulation

ensure availability and affordability of TM/CAM, including essential herbal medicines

promote therapeutically-sound use of TM/CAM by providers and consumers

11

22

33

44

Policy:Policy:

Safety, efficacy and quality:Safety, efficacy and quality:

Access:Access:

Rational use:Rational use:


1212

WHO Global Survey and Database of National Policy and Regulation of TM/CAM

WHO Global Survey and Database of National Policy and Regulation of TM/CAM and Herbal Medicines including information from 141 countries, 2004

Summary report of the global survey on national policy on traditional medicine and regulation of herbal medicines 2005


1313

WHO Global Survey and database of traditional medicine

To collect updated and comprehensive information on To collect updated and comprehensive information on TM/CAM policies and regulations of herbal medicines to TM/CAM policies and regulations of herbal medicines to make analysis on the current situation and major challenges make analysis on the current situation and major challenges

To clarify what are specific needs on capacity building To clarify what are specific needs on capacity building regarding TM/CAM and regulations of herbal medicines regarding TM/CAM and regulations of herbal medicines and what directed support WHO should provide to the and what directed support WHO should provide to the Member States accordingly. r To update the document Member States accordingly. r To update the document “Regulatory Situation of Herbal Medicines- a world wide “Regulatory Situation of Herbal Medicines- a world wide review”. review”.

To monitor the impact of the WHO Strategy for Traditional To monitor the impact of the WHO Strategy for Traditional Medicine in relation to present national policy and Medicine in relation to present national policy and regulation on TM/CAM/herbal medicines. regulation on TM/CAM/herbal medicines.

Objectives


1414

Challenges of definition of herbal medicines

Definition Definition Finished herbal productsFinished herbal products

Finished herbal products consist of herbal preparations made from Finished herbal products consist of herbal preparations made from one or more herbs. If more than one herb is used, the term mixture one or more herbs. If more than one herb is used, the term mixture herbal product can also be used. Finished herbal products and herbal product can also be used. Finished herbal products and mixture herbal products may contain excipients in addition to the mixture herbal products may contain excipients in addition to the active ingredients. However, finished products or mixture products active ingredients. However, finished products or mixture products to which chemically defined active substances have been added, to which chemically defined active substances have been added, including synthetic compounds and/or isolated constituents from including synthetic compounds and/or isolated constituents from herbal materials, are not considered to be herbal.herbal materials, are not considered to be herbal.

Recommendation from workshop of herbal medicines, 11Recommendation from workshop of herbal medicines, 11 thth ICDRA, 2002 ICDRA, 2002Member States should strengthen the post-marketing surveillance Member States should strengthen the post-marketing surveillance system of herbal medicines. Particular attention should be given to system of herbal medicines. Particular attention should be given to the possible adulteration of herbal medicines by chemicals or other the possible adulteration of herbal medicines by chemicals or other ingredients which have not been labelled.ingredients which have not been labelled.


1515

Number of Member States with Recently Established Herbal Medicines Law or Regulation

0

2

4

6

8

10

12

14

16

14 4 5 2 8 7 13 16 9 5

Before 1986

1986 - 1987

1988 - 1989

1990 - 1991

1992 - 1993

1994 - 1995

1996 - 1997

1998 - 1999

2000 - 2001

2002 - 2003

Number of Countries before 1986: 14

Number of Countries Total: 83

65% of respondents have

established herbal medicines law or regulation

42 (49%) declared regulations were in the process of being developed.


1616

Types of herbal medicines regulation

46

22

43

0 10 20 30 40 50

Same law orregulation as for

conventionalpharmaceuticals

Separate law orregulation for

herbal medicines

The law orregulation for

herbal medicinesis partly the

Number of Countries

Respondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents


1717

Regulatory status of herbal medicines

21

12

10

16

30

39

48

99

50

0 20 40 60 80 100 120

No Status

Other

Functional Food

Health Food

Herbal Medicines as a separateregulatory category

Self-medication only

Dietary Supplements

Over the Counter Medicines (O.T.C)

Prescription medicines

Number of CountriesRespondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents


1818

Challenges of regulatory status of herbal medicines

e.,g Garlice.,g Garlic If Garlic intends to be used as food spice, it is food, but if it If Garlic intends to be used as food spice, it is food, but if it

is used to stop diarrhoea, it is herbal medicines is used to stop diarrhoea, it is herbal medicines Garlic gel is categorised a herbal medicine product in Garlic gel is categorised a herbal medicine product in

GermanyGermany Garlic gel is categorised a food supplement in UK and USA Garlic gel is categorised a food supplement in UK and USA Garlic gel is categorised a health food in JapanGarlic gel is categorised a health food in Japan


1919

Challenges of regulatory status of herbal medicines

It is difficult to distinguish between herbal medicines It is difficult to distinguish between herbal medicines and health food or diet-supplement and health food or diet-supplement

Definition depend on countries own used experienceDefinition depend on countries own used experience Definition highly depend on Definition highly depend on labeling and intended uselabeling and intended use

(claims) (claims) Highly depend national regulation of food and Highly depend national regulation of food and

medicines medicines Clinical or bibliographic data on efficacy could refer to Clinical or bibliographic data on efficacy could refer to

regulate products into diet-supplement or medicine regulate products into diet-supplement or medicine categoriescategories


2020

Types of claims allowed for herbal medicines

5

7

50

62

91

40

0 20 40 60 80 100

No claims can be made according tothe law

Other claims

Structure/function claim

Nutrient content claims

Health claims

Medical claims

Number of CountriesRespondents were able to answer with more than one option, if applicable, so the total number exceeds number of respondents


2121

What is "evidence" in the field of medicine?

A

B

C

A. Randomized Controlled Trials 8%(RCT)

B. Well-conducted Clinical 14%Studies

C. Expert Committee Reviews 28%or the clinical experience of respected authors.

“Using Clinical Guidelines to Improve Patient Care within the NHS "1996

Randomized selection, Double-blinded, Placebo-controlled trials.


2222

Level of evidence requirement (Australia)

Level of claim

Type of claim Evidence required of support claim

HIGH Treats/cures/manages any disease/disorder.

Prevention of any disease or disorder.

Treatment of vitamin or mineral deficiency

diseases.

High level. Registration only –evaluated by the CMEC, MEC (Medicines Evaluation Committee) or the ADEC (Australian Drug Evaluation Committee).

MEDIUM Health enhancement2.

Reduction of risk of a disease/disorder.

Reduction in frequency of a discrete event.

Aids/assists in the management of a named

symptom/disease/disorder.Relief of symptoms of

a named disease or disorder3.

Medium level. Sponsor must hold the evidence for Listable goods.

GENERAL Health maintenance, including nutritional

support.Vitamin or mineral supplementation4.

Relief of symptoms (not related to a disease or

disorder)3.

General level. Sponsor must hold the evidence for Listable goods.


2323

Level of evidence required for the regulation of TM/CAM

Two types of evidence which can be used to support claims (EU)

scientific evidence evidence based on traditional use of products, which

have been on the market for at least 30 years without any risks reported. (15 years within European countries and 15 outside European countries)


2424

Number of Registered Herbal Medicines

0

2

4

6

8

10

12

14

16

18

Number of Countries

Number of Herbal Medicines Registered18 8 9 5 4 4 18

1-50 51-100101-200

201-300

301-500

500-1000

1000 and

Number of Countries Total: 66


2525

Number of Member States with Regulatory Requirements for Good Manufacturing

Practice

28

15

6

59

73

30

0 20 40 60 80

Same rules of goodmanufacturing practice

Adherence toinformation in

Special GMP rules

No requirements

Question not answered

Other Namely

Number of Member States


2626

Major problems of international herbal markets

Quality problems Quality problems Quality inconsistence Use wrong species Labelling problem lack precautionsIncluding heavy metalsIncluding chemical substance or

illegal substance without announcement

Other problemsOther problemsLack registration information of

products in in the original countries Lack producer information in the

original countries Lack communication between

national drug authorities of imported and exported countries


2727

102

88

81

64

33

Lack of research data

Lack of appropriate controlmechanisms

Lack of education andtraining

Lack of expertise

Other

Main Difficulties Regarding Regulatory Issues on Traditional Medicines


2828

Member States' needs for WHO Support

67

66

50

16

44

48

47

50

44

55

8

4

7

5

3

9

12

0

68

83

70

0 20 40 60 80 100 120 140

Information-sharing on regulatory issues

Herbal medicine safety monitoring workshops

General guidelines on research and evaluation ofherbal medicines

Provision of databases

Herbal medicine regulation workshops

Global meetings

Other

Number of Member States

Much needed

Needed

Not needed

127

116

117

117

110

105


2929

ASEAN Consultative Committee for Standards And ASEAN Consultative Committee for Standards And Quality (TMHS- PWG, ACCSQ)Quality (TMHS- PWG, ACCSQ)

TMHS-PWG formed in August 2004 to implement measures on TMHS-PWG formed in August 2004 to implement measures on TM & HS under Healthcare integration roadmapTM & HS under Healthcare integration roadmap Chaired by IndonesiaChaired by Indonesia Co-chaired by Malaysia Co-chaired by Malaysia

Member countries (10 countries)Member countries (10 countries)Brunei Darussalam, Brunei Darussalam, Cambodia,Cambodia, Indonesia, Indonesia, Lao, Lao, Malaysia, Malaysia, Myanmar, Philippines, Myanmar, Philippines,

Singapore, Singapore, Thailand, Thailand, Vietnam Vietnam

ASEAN Regulatory Cooperation for Herbal Medicine


3030

Why need to set up the TMHS-PWG

ASEAN consider the need to remove technical barriers of trade in order to facilitate the implementation of the Common Effective Preferential Tariff (CEPT) to realize the ASEAN Free Trade Agreement (AFTA) and to create a stable, prosperous and highly competitive ASEAN economic region.

To respond the new dynamics of the global challenges, ASEAN leaders have also approved to pursue accelerated integration of eleven priority sectors in 2010 which include Traditional Medicines and Health Supplement Products and formed a Product Working Group Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG)

Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG)


3131

Exchange, review and analyze information on the existing regulatory framework/regime including standard, definition, terminologies, and technical infrastructure in Member Countries.

Study the existing regulatory framework/regime of selected countries and internationally accepted technical guidelines

Enhance the technical infrastructure including mutual confidence in testing and conformity assessment

Identify areas for possible harmonization and MRAs

Objectives

Traditional Medicines & Health Supplements Product Working Group (TMHS – PWG)


3232

ASEAN Regulatory Cooperation for Herbal Medicine

TMHS-PWG meets 2 x/year and to date 3 meeting TMHS-PWG meets 2 x/year and to date 3 meeting had been conductedhad been conducted

Certain member countries is assigned to further Certain member countries is assigned to further review, study and analyzes technical requirement review, study and analyzes technical requirement on specific areas which will then be discussed during on specific areas which will then be discussed during the meeting and or distributed between the meeting the meeting and or distributed between the meeting to member countries for further commentsto member countries for further comments


3333

1. ASEAN consensus on specific area of technical requirements for harmonization, achieved

OBJECTIVE 1

1.1.Exchange of information and analysis of the existing standard definition, terminologies, regulation & procedures amongst ASEAN Member Countries

1.3.Specified areas on the technical requirements for harmonization agreed upon among Member Countries

1.2. Comparative study on International and other regional technical requirements for TMHS, conducted

Template for exchange of information developed and agreed upon.

Technical requirements (including terminology and definition) of Member Countries compiled and analyzed

Profile of Technical requirements of Member Countries developed

Terminology and definition on TMHSstandardized in ASEAN

Technical Requirementsand guidelines of international and other regionalorganization compiled, compared and analyzed

Technical requirementsof selected other countries compiled, compared and analyzed

Appropriate model for ASEAN recommended

Specific Areas for Harmonization identified and agreed upon

STRATEGIES

EXPECTED OUTPUTS

Working programme of ASIAN TMHS – PWG


3434

Why need to set up the FHH Traditional Chinese medicine has been commonly used and traded with similar theory system among these countries. However, the quality standards and technical requirements in these countries vary. There is a need for cooperation in harmonization of standards for traditional Chinese medicines. Seven founding member parties: Seven founding member parties: 1. Australia1. Australia 2. China 2. China 3. Japan3. Japan 4. Republic of Korea 4. Republic of Korea 5. Singapore5. Singapore 6. Viet Nam 6. Viet Nam 7. Hong Kong (SAR China)7. Hong Kong (SAR China)

Western Pacific Regional Forum for the Harmonization of Herbal

Medicines (FHH)


3535

Nature of FHH

The FHH is a technical forum involving drug regulatory authorities of founding member parties to explore the way and measures for achieving the objectives set up by founding parties.

The role of the FHH is to provide technical documents and consensus on technical issues related to safety, efficacy and quality of herbal medicine.

Western Pacific Regional Forum for the Harmonization of Herbal

Medicines (FHH)


3636

Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH)

To provide a scientific basis for improvement or To provide a scientific basis for improvement or development of standards in safety, quality and development of standards in safety, quality and efficacy of herbal medicines;efficacy of herbal medicines;

To reduce duplication of efforts;To reduce duplication of efforts; To create economic use of valuable resources;andTo create economic use of valuable resources;and To address lack of standards in areas of public To address lack of standards in areas of public

health importance to regulatory agencies.health importance to regulatory agencies.


3737

Western Pacific Regional Forum for the Harmonization of Herbal Medicines (FHH)

Standing Committee

Sub-committee IIQuality Assurance & Information

Sub-committee INomenclature & Standardization

Validated Analytical Method

Nomenclature

Chemical Reference Standards and Reference of Medicinal Plant Materials

Testing method in Monograph

Information on General testGood Manufacturing Practice

Good Agricultural Practice

Adverse Drug Reaction, Sub-committee III

Secretariat (Provisional)

Hong Kong

Secretariat (Provisional)

Hong Kong

EWG

EWG

EWG

EWG

EWG

EWG

EWG


3838

European Union

1. European Parliament (representation of the will of the EU citizens;

legislative power; control over community institutions)

2. European Commission (executive body)

3. Council of the EU (legislative body)

Agencies of the MS and of the European Union (EMEA)Specific Committee on Herbal Medicinal Products


3939

Committee on Herbal Committee on Herbal Medicinal Products Medicinal Products

Austria France Lithuania SloveniaEstonia Germany Luxembourg SpainBelgium Greece Malta SwedenCyprus Hungary Netherlands United Kingdom Czech Rep. Ireland Poland Denmark Italy Portugal Finland Latvia Slovak Republic

EEA Members:Norway, Iceland

Observer: EDQM/Europ. Pharm.

Romania; Bulgaria


4040

Herbal Medicinal Products in the EU Access to the market

Marketing Authorization

1. Full documentation with new tests and trials

mandatory for:

- any herbal medicinal product never marketed in the EU

- therapeutic innovations- new indication / therapeutic area for “old”

products

2. Full bibliographic documentation (well-established use)

Registration

3. Simplified dossier for traditional products


4242

Registration of traditional herbal medicinal productsapplicable to traditional herbal medicinal products

Article 16c 1 (c)

> 30 years of medicinal use within the EU or

> 15 years in and > 15 years outside the EU

Deviations may be decided by the Herbal Committee if requested by a Member State

The new simplified registration procedure


4343

Third PARLATINO Inter-parliamentary Health Third PARLATINO Inter-parliamentary Health Conference was held in Sao Paulo in 2005 and Conference was held in Sao Paulo in 2005 and attended by 74 parliamentarians from 17 countries.attended by 74 parliamentarians from 17 countries.

The “Parliamentary Group on Traditional and The “Parliamentary Group on Traditional and Complementary Medicine” was created with the Complementary Medicine” was created with the purpose of monitoring the question of legislative purpose of monitoring the question of legislative norms on TCM in Latin America. norms on TCM in Latin America.


4444

ProjectProject Drawing up a draft framework law on traditional Drawing up a draft framework law on traditional

and complementary medicine for approval by and complementary medicine for approval by PARLATINO (first stage).PARLATINO (first stage).

Preparation of ad hoc legislation on traditional Preparation of ad hoc legislation on traditional and complementary medicine based on the and complementary medicine based on the framework law adopted by PARLATINO, for framework law adopted by PARLATINO, for discussion and approval by the national congresses discussion and approval by the national congresses and legislative assemblies of the countries of Latin and legislative assemblies of the countries of Latin America (second stage).America (second stage).


4545

WHO Mandate: to act as directing and coordinating authority on international health work; and to develop, establish and promote international standards with respect to biological, pharmaceutical and similar products;

PAN American Sanitary Conference supports the development of essential drug policies that include drug legislation and registration; drug manufacturing and marketing; and drug use and drug financing; that promotes the establishment of pharmaceutical services and drug information for health workers and public education promoting the rational use of medicines

PAHO/WHO and PANDRH

42nd PAHO/WHO Directing Council: September 200042nd PAHO/WHO Directing Council: September 2000Resolution supporting PANDRH Resolution supporting PANDRH


4646

PANDRH Structure and Operating System

Consumers

Academia

Professional Ass

Pan American Conference

Secretariat

Steering Committee

WG WG

WG WG

WG

WG

RegulatorsAndean AreaCARICOMMERCOSURSICANAFTAINDUSTRY


4747

Organization of PADRHOrganization of PADRH

NRA NRA MembersMembers Alternate Alternate

NA:NA: MexicoMexico USA USA

CA*:CA*: Costa RicaCosta Rica PanamaPanama

CR*:CR*: Trinidad &Tobago Trinidad &Tobago BarbadosBarbados

ME*:ME*: ArgentinaArgentina ChileChile

AA:AA: ColombiaColombia BoliviaBolivia

Pharmaceutical IndustryPharmaceutical Industry

One rep from FIFARMA One rep from FIFARMA --------------------------

One rep from ALIFAROne rep from ALIFAR --------------------------


4848

Mission of ANDRAH Working Group of Herbal Medicines

To foster a common understanding of MP in the Region of the Americas and to develop recommendations to promote regulatory harmonization taking into consideration the traditional and sustainable use of Medicinal Plants.


4949

Objectives of ANDRAH Working Group of Herbal Medicines

To promote and strengthen the exchange of information about MP

To promote the assurance of quality, safety and efficacy of MP in the Americas, including the development of programs for vigilance and control;

To develop proposals for harmonized regulatory activities in the area of MP; and to support countries in the implementation of these activities once they have been adopted by PANDRH;

To promote activities and educational programs on MP for health care providers, consumers, and the public in general.


5050

WHO Working group meeting on international WHO Working group meeting on international regulatory cooperation on herbal medicinesregulatory cooperation on herbal medicines

WHO Working group meeting on regulatory cooperation on WHO Working group meeting on regulatory cooperation on herbal medicinesherbal medicines in Ottawa, Canada from 28 to 30 November in Ottawa, Canada from 28 to 30 November 2005 hosted by the Health Products and Food Branch of Health 2005 hosted by the Health Products and Food Branch of Health Canada. Canada.

29 regulatory authorities from 16 countries participated, 29 regulatory authorities from 16 countries participated, regulatory authorities representing each of the 6 regional/sub-regulatory authorities representing each of the 6 regional/sub-

regional/inter-regional regulatory cooperation groups including regional/inter-regional regulatory cooperation groups including Forum on Harmonization of Herbal Medicines (FHH), the Pan Forum on Harmonization of Herbal Medicines (FHH), the Pan American National Drug Regulatory Authorities American National Drug Regulatory Authorities Harmonization (PANDRH), the European Herbal Medicines Harmonization (PANDRH), the European Herbal Medicines Committee, the ASEAN Product Working Group on Committee, the ASEAN Product Working Group on Traditional Medicines and Health Supplements (TMHSPWG) Traditional Medicines and Health Supplements (TMHSPWG) and the Latin American Parliament (PARLATINO)and the Latin American Parliament (PARLATINO)


5151

International regulatory Cooperation on Herbal Medicines (IRCH)

Objectives globally promote and facilitate the globally promote and facilitate the safe use of herbal medicines, safe use of herbal medicines,

including through regional initiatives, through sharing information including through regional initiatives, through sharing information and fostering dialogue;and fostering dialogue;

facilitate and strengthen cooperation between national drug facilitate and strengthen cooperation between national drug regulatory authorities by sharing experience and information related regulatory authorities by sharing experience and information related to the regulation, safety and quality of herbal medicines; to the regulation, safety and quality of herbal medicines;

further discuss existing requirements and standards to promote the further discuss existing requirements and standards to promote the regulation, safety and quality of herbal medicines;regulation, safety and quality of herbal medicines;

further share research and knowledge of traditional medicines to further share research and knowledge of traditional medicines to reduce duplication;reduce duplication;

recommend future activities to WHO related to the safe use of herbal recommend future activities to WHO related to the safe use of herbal medicines;medicines;

recommend important issues to ICDRA for further discussion related recommend important issues to ICDRA for further discussion related to the safe use herbal medicines.to the safe use herbal medicines.


5252

International regulatory Cooperation International regulatory Cooperation on Herbal Medicines (IRCH)on Herbal Medicines (IRCH)

Initial scope of activities of IRCHIRCH is in the initial stages. There are two main IRCH is in the initial stages. There are two main

activities:activities: Information sharing on technical matters Information sharing on technical matters

related to regulatory information of herbal related to regulatory information of herbal medicines via electronic communication as the medicines via electronic communication as the main tool, on a daily basis, through an main tool, on a daily basis, through an Information Focal Point nominated by each Information Focal Point nominated by each Member Country of IRCH.Member Country of IRCH.

Convening annual meetings of IRCH.Convening annual meetings of IRCH.

Second working group meeting will take place in Second working group meeting will take place in October 2006, Beijing, ChinaOctober 2006, Beijing, China


5353

Conclusion Conclusion

Status and regulation of herbal medicines vary between Status and regulation of herbal medicines vary between country to countrycountry to country

The most difficulties for national authorities are the The most difficulties for national authorities are the lack lack of research data, the lack of appropriate control of research data, the lack of appropriate control mechanisms, the lack of education and training of mechanisms, the lack of education and training of providers and the lack of expertise. providers and the lack of expertise.

Information exchange and sharing national experience is Information exchange and sharing national experience is crucial aspect crucial aspect

WHO will provide support to the international and WHO will provide support to the international and regional regulatory cooperation for herbal medicines regional regulatory cooperation for herbal medicines


5454

Traditional Medicine Department of Technical Cooperation for Essential Drugs and Traditional Medicine

Websites: http://www.who.int/medicines/areas/traditional/en/index.html

http//www.who.int E-mail: [email protected]

Thanks for all of your support and cooperation in the past and

looking forward in the future

briefing on tbs training course 18 sep 2006 geneva 1 dr xiaorui zhang coordinator traditional...

Documents

tbs training course

regulation of herbal

essential herbal medicines

traditional medicine

traditional chinese

western medicine herbal

alternative medicine

tmcam policies