The pharmaceutical market in Indonesia ranks the largest market in the ASEAN regions, with the market value expected to hit IDR 141.6 billion (USD 10.11 billion) by 2021. There is a steep increase in the number of drug registrations in Indonesia due to the huge market size and regulatory advantages over other countries. Key highlights […]

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This article is a sequence of the Regulatory & Drug Approval Process in the United States, Part-I, which describes the Investigational New Drug (IND) approval process, New Drug Approval (NDA), and Generic drug approval process. In this article, we will discuss the market approval process of biologics, biosimilars, orphan drugs, and various drug approval pathways.  Which is the regulatory authority […]

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