Pharmaceutical and Drug Registration
Indonesia, Malaysia, the Philippines, and Thailand
Is your company interested in registering a drug or pharmaceutical in Indonesia, Malaysia, the Philippines, or Thailand?
The international medical consultants at Pacific Bridge Medical (PBM) have specialized in Asian markets for over two decades. Let our team use our expertise to streamline the product registration process for your company.
Keep reading to learn more about the pharmaceutical and drug registration process and discover how we can help your organization.
Registering a Pharmaceutical Or Drug
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.
Consult with An Expert Right Away
Minimize the difficulties your organization faces with drug registration and pharma approval issues. Our consultants offer years of experience working with companies like yours. We can help you streamline your efforts and ensure that your company is able to register the product in their own name. You can contact us for a free consultation to discuss the specific needs of your company.
For more information on pharmaceutical and drug registration in the other Asian countries, please see read the PBM publications listed below.
Go back to the PacificBridgeMedical.com homepage
- 2011 Strategies for Success in China, Japan, and India
- 2008 Managing Asian Cultural/Business Diversity
- 2008 ASEAN Medical Device Harmonization Trends
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