The Association of Southeast Asian Nations (ASEAN) Common Technical Documents (CTD) must be used, and ASEAN standards should be followed. It can take up to 3 years for a pharmaceutical product to be registered.
Generic pharmaceutical pricing is regulated by the government. Pharmaceuticals included in the Essential Drugs List -- 92% of which are generic and 2.5% of which are innovator -- cannot be sold for more than a 50% margin. Other generics are also subject to pricing restrictions.
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