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Indonesia's Pharma Market: BPOM Drug Registration Decoded
📢 DDReg Knowledge Capsule – Episode [30]This podcast provides an in-depth analysis of Indonesia's regulatory landscape, the largest pharmaceutical market in Southeast Asia, with a population exceeding 270 million. It details the methodical and documentation-intensive drug registration process managed by the National Agency of Drug and Food Control (BPOM). Key insights include the mandatory requirement for a local registration holder, the specific structure of the ACTD dossier, and technical requirements such as Zone IVb stability data and Bahasa Indonesia labeling. The guide is an essential…
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