What Indonesia BPOM Drug Registration Regulations Badan Pengawas Obat dan Makanan Marketing Authorisation GMP Pharmacovigilance and Halal Certification Framework requires
The Indonesia Badan Pengawas Obat dan Makanan (BPOM) National Agency of Drug and Food Control administered under Presidential Regulation No. 80 of 2017 (as amended) establishes the comprehensive pharmaceutical regulation framework organised through BPOM Regulations including BPOM Regulation No. 24 of 2017 on Criteria and Procedures for Drug Registration BPOM Regulation No. 26 of 2018 on Online Drug Registration BPOM Regulation No. 34 of 2018 on Good Manufacturing Practices BPOM Regulation No. 13 of 2019 on Distribution of Drugs and BPOM Regulation No. 27 of 2018 on Pharmacovigilance organised across operative chapters covering Chapter 1 General Provisions Chapter 2 Pre-Registration including pre-submission consultation Chapter 3 Drug Registration covering New Drug Registration Variation Registration and Renewal Registration with mandatory Common Technical Document format submission Chapter 4 Good Manufacturing Practices Chapter 5 Pharmacovigilance Chapter 6 Distribution and Logistics including Marketing Authorisation Holder requirements and local representation Chapter 7 Pricing for Essential Medicines Chapter 8 Inspection and Surveillance and Chapter 9 Sanctions including administrative sanctions warning suspension and revocation. Integrated with the National Halal Product Assurance Agency (BPJPH) for halal certification of medicines under Law No. 33 of 2014 effective October 2024 for over-the-counter products with phased implementation for prescription drugs.
Pillar: Pharmaceuticals & Life Sciences · Authority: Indonesia Badan Pengawas Obat dan Makanan (BPOM) · Version: 1.0.0 · Last updated:
Primary source: https://www.pom.go.id/
SHA-256 integrity: ee48b6695d256b4d94d384429be5631b28612c92669a8d72e069d31f803ea150
Primary Citations — 8 traced to source
- Indonesia Badan Pengawas Obat dan Makanan (BPOM) portal https://www.pom.go.id/
- BPOM Regulation 24/2017 on Drug Registration Criteria and Procedures https://www.pom.go.id/
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