EPISODE · Jun 11, 2026 · 21 MIN
Indonesia's Pharma Market: BPOM Drug Registration Decoded
from DDReg Knowledge Capsule · host DDReg Pharma
📢 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 resource for understanding the complexities of obtaining a Nomor Izin Edar (NIE) and managing long-term pharmacovigilance obligations.For More Visit our Blog -:https://resource.ddregpharma.com/blogs/bpom-drug-registration-indonesia-market-entry-guide/
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Indonesia's Pharma Market: BPOM Drug Registration Decoded
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