Pharmaceutical/Drug Registration

Indonesia, Malaysia, the Philippines, and Thailand

The main agency responsible for regulating pharmaceuticals/drugs in Indonesia is the National Agency of Drug and Food Control (NA-DFC). The main functions of NA-DFC include pre-market evaluation of medical products, legislation, regulation, standardization, and GMP certification.

In Malaysia, the Drug Control Authority (DCA) is the main regulatory body responsible for the registration of pharmaceuticals/drugs. They also monitor the quality of registered products in the market and keep track of adverse drug reactions.

In the Philippines, the Bureau of Food and Drugs (BFAD) was established to ensure the safety, efficacy, purity and quality of health product, including pharmaceuticals/drugs. For pharmaceuticals/drugs, the Food, Drug and Cosmetic Act is the main regulation.

In Thailand, the Thai Food and Drug Administration (FDA), under the Ministry of Public Health (MOPH), is responsible for pre-marketing and post-marketing of pharmaceuticals/drugs and also conducts product surveillance.

For more information on pharmaceutical/drug registration in the other Asian countries, please see the following PBM publications and/or contact us to discuss your specific needs.