1 FDA Thailand By HIV Module/Marketing Group Mr. Manaswee Arayasiri

2 FDA Thailand Introduction Drugs registration The effect of FDA on Marketing

3 Introduction About FDA Thailand Role and Responsibility Relating Acts Administration of Acts Organization of FDA for controlling

4 About FDA Thailand Consumer protection activities on food and drugs have begun in Thailand since 1909 Established in 1922 as a Narcotic division In 1937, the agency renamed to Food and Drug division

5 About FDA Thailand In 1953, the agency renamed to Division of Food and Drug Control. In 1974, Division of Food and Drug Control was promoted to be the Office of Food and Drug Administration, having the status as department of Ministry of Public Health.

6 Roles and Responsibilities Major is to ensure that health products(i.e. food, drug etc.) available to consumers are of standard quality, efficacy, and safety.

7 Roles and Responsibilities Main tasks are to control and monitor both pre- and post-marketing phases of manufacture, import, transport, storage and sale

8 Relating Act Drug Act 1987 (5th revision) Food Act 1979 Cosmetic Act 1992 Narcotic Act 1987 (3rd revision)

9 Relating Act Psychotropic Substances Act 1992(3rd revision) Volatile Substances Act 1990 Medical Devices Act 1988

10 Administration of Acts Committees of drug, food, narcotics, cosmetics etc. follow Acts Committees to develop policies and promote technological development on food, drugs and chemical safety

11 Organization of FDA for controlling Drug control division Food control division Toxic substance control division Narcotic control division Cosmetic control division Medical device control division Public relation and Advertisement control division

12 Drug Registration How to register drugs Drugs registration procedure Other registration

13 How to register drug Contact Drug control division FDA Thailand Ministry of Public Health Nonthaburi Thailand address:

14 Drug registration procedure In this HIV module, Assume use procedure of new drugs registration in term of Generic drug Generic drug is an imitation of an original brand-name drug, when the patent or trademark protection on original brand-name drug expires

15 Drug registration procedure Step 1 : Asking permission for Bioequivalence study Step 2 : Asking permission for produce/order sample drug for study Step 3 : Asking permission for register Pharmacopoeia

16 Definition Pharmacopoeia is a book described drugs; one issued by an officially recognized authority and serving as standard Bioequivalence study is study drugs in term of therapeutic response compare between innovator product and original product

17 Drug registration procedure Step 1 : Asking permission for Bioequivalence study

18 Document for application Label every size of container Accompany literature Clinical trial report Certificate of free sale Detail of protocol for Bioequivalence study

19 Procedure

20 Procedure (Continue)

21 Drug registration procedure Step 2 : Asking permission for produce/order sample drug for study

22 Document for application Label every size of container Accompany literature Certificate of GMP Certificate of free sale Certificate of Analysis

23 Definition Certificate of GMP is certificate for factory about Manufacturing practice follow WHO practice Certificate of Free Sale is document present that drug is legally sold in the country of origin

24 Definition Certificate of Analysis is report present result of pharmaceutical product standard checking

25 Procedure

26 Procedure (Continue)

27 Drug registration procedure Step 3 : Asking permission for register pharmacopoeia

28 Document for application Sample drugs Label every size of container Accompany literature Result of Bioequivalence study Finished product Specification Certificate of free sale Certificate of import drug (Step 2)

29 Procedure

30 Procedure (Continue)

31 Other registration License to produce drugs License to sell drugs

32 The effect of FDA on Marketing Cost of product Regulation in Selling

33 Cost of Product Bioequivalence Study License for register, production, selling drug Quality control in production and environment

34 Regulation in Selling Producer must have license for sell drug Amount of selling must follow license Advertisement ; clearly, include side effect and no over/false the real properties

35 Thank you very much Dr. Suvit Dr. Maria Mrs. Podjana all listeners

36 Thank you for pay attention