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01/08/2012
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Roles and Responsibilities FDA 

 Roles and Responsibilities

The main role of the Thai FDA is to protect consumer,s health, especially, to ensure safety, quality and efficacy of health products within its remit. These include: foods, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics and hazardous substances available in the country. This has to be implemented in accordance with national legislation and international agreements as follows:

1.Drug Act, B.E. 2510 (1967)
2.Psychotropic Substances Act B.E. 2518 (1975)
3.Food Act, B.E. 2522 (1979)
4.Narcotics Act, B.E. 2522 (1979)
5.Medical Devices Act, B.E. 2531 (1988)
6.The Emergency Decree on Prevention of Abuse of Volatile Substances, B.E. 2533 (1990)
7.Cosmetics Act, B.E. 2535 (1992)
8.Hazardous Substances Act, B.E. 2535 (1992)
9.The Single Convention on Narcotic Drugs 1961, commentary on the protocol amended in Geneva on March 25, 1972.
10.The International Convention on Psychotropic Substances, 1971.
11.The International Code on Marketing of Breast Milk Substitute, 1981
12.The United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988.

By law, certain important issues are decided by committees, whose members, all experts in their fields, are appointed by the Minister of Public Health. Currently, there are six committees : Drugs, Food, Cosmetics, Narcotics, Psychotropic Substances and Medical Devices.

There are two committees whose members are appointed by the other ministries. They are the Committee on the Prevention of Abuse of Volatile Substances appointed by two ministers (Industry and Public Health), and the Hazardous Substance Committee appointed by three ministers (Public Health, Industry and Agriculture).

At the national level, the Cabinet appoints three committees: the National Drug Committee, the National Food Committee and the National Chemical Safety Committee. The national committees are mainly assigned policy and development issues and collaborative action with other agencies to facilitate the implementation of the food, drug and chemical safety program as well as the control system.

The roles and responsibilities of the FDA may be grouped into five main areas:

1. Pre-marketing control

This includes control of manufacturing facilities, product quality and advertising before product-launch to the market. In each case, compliance is required with the relevant legislation and regulations.

2. Post-marketing control

The aim of this activity is to investigate manufacturing facilities and product quality and to ensure that they maintain compliance with previously-approved standards and with legislation and regulations. For example, samples of products are regularly inspected and taken to check for compliance and quality. Previously-approved products are revisited periodically to ascertain the consistency of manufacturing and product standards over time.

3. Surveillance program for consumers' safety

The aim of this Program is to detect any adverse effects or unexpected outcomes from consumer use of products. Research and epidemiological data on adverse effects, including technical information, is collected, summarized, interpreted and reported. There are also operational centers, such as the Adverse Product Reaction Monitoring Center (APRMC) and the International Program on Chemical Safety (IPCS). Information is exchanged with other agencies at local and international level.

4. Consumer Education

Consumers are supplied with sufficient, accurate information to enable them to choose products wisely. Access to such information, provided by the FDA, is available from many sources: television, radio, newspaper, leaflets, internet, and so on. FDA,s campaigns on priority topics have been regularly conducted in department stores, schools and villages in many parts of the country. There are many sources for consumers to use so that they can obtain further useful information and be in a better position to protect themselves.

5. Technical Support and Cooperation with other agencies

The FDA has conducted many interesting seminars and workshops, with participants from both public and private sectors. On the other hand, officials from the Thai FDA are sent to join seminars and conferences, both local and abroad. As a result, with a widened perspective, they can work more effectively at home. The Good Manufacturing Practice (GMP) program is another example demonstrating successful cooperation with other organizations, in this case, with universities and drug manufacturers. In relation to cooperation in terms of research and development, the FDA is continually supportive of such endeavor, and some research projects are partly or wholly funded by the agency.