Drug registration and approval process varies from one country to another although the objective of all regulatory authorities of the world is same. Each regulatory authority ensures that only safe, effective and quality medicines reach to the consumer. Small countries cannot bear the financial burden of setting up their own regulatory authority and hence countries of the region join hand together to establish regional regulatory authority. ASEAN is one such regional regulatory authority founded in August 1967 in Bangkok and currently has 10 member countries. The ACTD (ASEAN Common Technical Document) format needs to be followed by the manufacturer who is willing to market the product in these member countries of ASEAN. Present article will give an overview of the drug registration process in ASEAN countries.
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