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Republic of the Philippines Department of Health

Food and Drug Administration

Importation of Unregistered Drug Products

Center for Drug Regulation and Research


I. Food and Drug Administration

II. Use of Unregistered Products

III. Issues for Discussion

Presentation Outline

5 May 2015 2

FDA

• Office under the Department of Health

• Created in 1963 by virtue of Republic Act 3720 as amended by Exective Order No. 175, and subsequently Republic Act No. 9711

4

Legal Bases

• Republic Act No. 3720 (as amended) – Foods, Drugs and Devices, and Cosmetics Act

• Republic Act No. 9711 – Food and Drug Administration (FDA) Act of 2009

5

Legal Bases

• Republic Act No. 9502 – Universally Accessible Cheaper Quality Medicines Act of 2008

• Republic Act No. 7394 – Consumer Act of the Philippines

6

Legal Bases

• Republic Act No. 6675 – The Generics Act of 1988

• Republic Act No. 10354 – The Responsible Parenthood and Reproductive Health Act of 2013

7

To ensure the safety, efficacy, purity, and quality of products we regulate through effective implementation of the national regulatory framework consistent with international best practice

MISSION 8

To be an internationally recognized center of regulatory excellence safeguarding the health of the Filipinos

VISION 9

QUALITY POLICY

Our highest commitment is to ensure the safety, efficacy and quality of health products.

Toward this end, we commit to establish science-based standards as basis for regulatory policies, to continually improve and maintain our competencies in relation to our regulatory function, and to deliver quality public service with integrity.

10

Regulatory Framework Elements

1. Licensing/Accreditation of establishments • GMP, GDP, GSP, GCP, and GLP

2. Pre-marketing assessment • Quality, safety, and efficacy (for innovative medicines)

• Quality+interchangeability (for generics)

3. Post-marketing surveillance • Safety (benefit/risk balance)

• Quality (quality testing and compliance monitoring)

4. Communication 11

1. Pharmacovigilance

• Safety monitoring of drugs on the market for unexpected health risks and informing the public of risks posed by specific drugs and other health products;

2. Monitoring, collecting, sampling and testing of drugs

3. Audits and inspection of manufacturers/ distributors/ retail outlets

4. Advertisements and claims monitoring

5. Consumer reporting of ADR

6. Product recall / Administrative sanctions

Post-Marketing Surveillance 12



Use of Unregistered Products

k), Section 7, amending Section 11 of RA 3720

• Prohibited acts:

Executive Order No. 175

• FDA recognizes the need for drugs and devices product/preparation which are not registered or are in the process of registration in the Philippines by patients who are terminally or seriously ill.

• Access to these products for these patients is morally, socially and ethically justified when there is no existing superior alternative therapy that can likely cure or adequately control their conditions.

5 May 2015 15

Administrative Order No. 4 s. 1992

5 May 2015 16

AO No. 4 s. 1992

Compassionate Special Permit for Restricted Use of Unregistered Drug and Devices Product (CSP)

• a special permit signed by the FDA Director granting a Specialized Institution (SI) and Specialty Society (SS) the privilege to avail of an unregistered drug and device product through a certain licensed establishment for certain kind/type of patients, specific volume and period.

17 5 May 2015

AO No. 4 s. 1992

• For patients suffering from the following conditions:

1. Acquired Immune Deficiency Syndrome (AIDS)

2. Cancer

3. Life-threatening conditions

5 May 2015 18

Application shall include:

• estimated volume needed

• the licensed drug/ device establishment through which the unregistered drug may be procured

• identify the names and address of the specialists qualified and authorized to use the product

AO No. 4 s. 1992 5 May 2015 19

Drug

Quantity requested per year Frequency of request

2013 2014 Total 2013 2014 Total

Colistimethate Na 1 M Unit vial 7600 37170 44770 13 23 36

Dipyridamole 10mg/2ml ampoule 10333 16382 26715 12 18 30

Glyceryl trinitrate 10mg/10ml amp 14990 9319 24309 8 20 28

Protamine sulfate 50mg/5ml vial 11475 6691 18166 13 22 35

Vasopressin 20 units/ml vial 4425 6895 11320 10 14 24

Adenosine 6mg/2ml vial 3963 5605 9568 15 30 45

Phenylephrine 1% 10mg/1ml vial 2700 4985 7685 9 17 26

Papaverine HCl 30mg/ml, in 2ml vial 1495 2908 4403 8 19 27

Esmolol HCl 10mg/ml, in 10 ml vial 1405 2958 4363 10 21 31

Milrinone lactate 10mg vial 2302 2057 4359 10 14 24

Dantrolene sodium 20mg/65mL vial 408 850 1258 11 20 31

Top Requested Drugs

Drug

Quantity requested per year Frequency of request

2013 2014 Total 2013 2014 Total

Sotalol 80mg tablet 10400 13030 23430 2 2 4

Propafenone 150mg tablet 4400 14500 18900 1 2 3

Liothyronine (Cynomel) 25mcg tablet 7220 7800 15020 4 4 8

Co-trimoxazole (Trimethoprim 16 mg/ml

+ Sulfamethoxazole 80 mg/ml) [Bactrim]

Solution for injection, in 5ml vial

1450 9112 10562 3 8 11

Fludrocortisone 0.1mg tablet 3100 5800 8900 2 4 6

Provocholine nebulization kit 1700 3400 5100 2 2 4

Provocholine 100mg/vial 288 475 763 2 2 4

Top Requested Drugs

Hospitals No. of applications per year

2013 2014 Total

St. Luke's Medical Center – Global City 6 12 18

St. Luke's Medical Center – Quezon City 8 8 16

Cardinal Santos Medical Center 8 7 15

The Medical City 5 7 12

Philippine General Hospital 7 3 10

Makati Medical Center 3 6 9

University of Santo Tomas Hospital 2 6 8

Asian Hospital and Medical Center 2 5 7

Manila Doctors Hospital 2 5 7

Philippine Heart Center 2 2 4

Top Requesting Hospitals

• Regular request (from 2 to 12 times a year) for permit to import of unregistered to be used for critical care, strictly for their own use

• Quantity is considered to be substantial

• Misalignment with the intentions of AO 4 s. 1992 – no specific patients identified

Conclusions

5 May 2015 23



Issues for Discussion

• Pending Applications

• Compliance to Clinical Reports

• Registered counterpart

Issues for Discussion

• 19 applications on hold submitted from 24 February to 31 March 2015

Pending applications

Pending applications CONTROL NUMBER DATE

RECEIVED

NAME OF COMPANY PRODUCT

1 2015022416455

1

24-Feb-15 Adventist Medical

Center - Bacolod

Thiopental sodium 500mg

powder for Injection

2 2015022416473

8

24-Feb-15 Makati Medical

Center

Methoxsalen (GEROXALEN

10mg capsule;

Fludarabine (FLUDARA) 50mg

vial

3 2015022416412

7

24-Feb-15 De La Salle

University Medical

Center

Protamine sulfate 50mg/ ml w/

4 drug products

4 2015022416455

1

24-Feb-15 Adventist Medical

Center - Bacolod

Phenylephrine 1% 10mg/ 1ml

ampoule; Colistimethate

sodium (COLOMYCIN) 1Million

Unit Vial


RECEIVED


5 201502241643

37

24-Feb-15 Mary Mediatrix

Medical Center

Dipyridamole (PERSANTIN)

10mg/ 2ml ampoule

6 201502261308

42

26-Feb-15 Perpetual Succour

Hospital

Dipyridamole (PERSANTIN)

10mg/2ml ampoule

7 201502261305

20

26-Feb-15 University of Santo

Tomas Hospital

Sulfamethoxazole (SMZ) 400mg +

Trimethoprim (TMZ) 80mg

(BACTRIM) 5ml ampule

8 201503031238

57

03-Mar-15 Davao Doctors

Hospital

Fludrocortisone acetate

100mcg tablet

9 201503041220

28

04-Mar-15 St. Luke’s Medical

Center

Dantrolene sodium 20mg/

70ml vial w/ 25 drug products

10 201503050923

09

05-Mar-15 Chinese general

Hospital and

Medical Center

Glyceryltrinitrate (NITRONAL)

1mg/ ml, 10ml ampoule;

Colistimethate sodium

(COLOMYCIN) 1 million Unit

Vial


RECEIVED


11 20150312102502 12-Mar-

15

Cardinal Santos Labetalol 100mg/ 20ml vial

12 20150316133902 16-Mar-

15

The Medical City Nicotine TDS Patch 21mg 14ct;

Nicotine TDS Patch 14mg 14ct;

Nicotine TDS Patch 7mg 14ct;

Nicorette Freshfruit 4mg;

Nicorette Freshfruit 2mg

13 20150317103602 17-Mar-

15

Asian Hospital

and Medical

Center

Gebauer’s Pain Ease

14 20150324130448 24-Mar-

15

AUF Medical

Center

Milrinone Lactate Injection

10mg/ vial w/ 4 drug products

15 20150324101744 24-Mar-

15

St. Luke’s Medical

Center

Methylene blue (PATENT BLUE

V) 2mg/ ml


RECEIVED


16 201503241013

08


Center

Cyclosporine SANDIMMUNE

50mg vial

17 201503241310

03

24-Mar-15 Jecson Medical

Center

Dipyridamole (PERSATIN)

10mg/ 2ml Solution for

infusion/ Intravenous/ Ampule

18 201503241313

23

24-Mar-15 Cebu Doctor’s

Univerrsity

Hospital

Persantin 10mg/ 2ml ampule

19 201503311636

245


Center

Vasopressin (PITRESSIN) 20

units/ ml w/ 22 drug products

• Low compliance to reporting • PMS is compromised

Compliance to Clinical Reports

Registered Counterpart Rho(D) Immune Globulin Intravenous Human

(WINRHO SDF) 1500 IU (300mcg) per 3ml,

lyophilized powder for injection, in vial

BR-681 Johnson & Johnson

(Phils), Inc

Adenosine (Adenocor) 6mg/2ml vial

DR-XY41332 International Apex

Pharmaceuticals, Inc.

DR-XY43539 SRS Pharmaceuticals

Phils. Inc

Esmolol HCl (Brevibloc) 10mg/ml, in 10 ml vial DR-XY42945 International Apex


Co-trimoxazole (Trimethoprim 16 mg/ml +

Sulfamethoxazole 80 mg/ml) [Bactrim] Solution for

injection, in 5ml vial

DR-XY44038 International Apex


Thiopental sodium 500mg

Powder for Injection Solution, in Vial DRP-5547

Ambica International

Trading Corp

Labetalol HCl injection 100mg/20ml vial DR-XY43857 International Apex


Verapamil HCl 2.5mg/ml ampoule DR-XY43909 Abbott Laboratories

(Philippines)

Registered Counterpart Fludarabine (Fludara) 50mg vial DR-XY26134

Sanofi-Aventis

Philippines, Inc

Azacitidine 100mg vial DR-XY41608 Invida Philippines, Inc

Cinacalcet HCl (Mimpara) 30mg tablet DR-XY43911 DeGa International

Pharma Corp

Cinacalcet HCl (Mimpara) 60mg tablet DR-XY43910 DeGa International

Pharma Corp

Potassium Iodide (Jodid) 100mcg tablet DR-XY32533 Merck, Inc.

• Use of registered products and consider therapeutic alternatives – New policy and NDAC

• Mandatory registration will be required for the products – MAH will have prioritized review – Separate meeting for local counterparts of MAH

and other importers

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