BPOM (Indonesia)

The National Agency of Drug and Food Control (BPOM — Badan Pengawas Obat dan Makanan) is Indonesia's national regulator for human and veterinary medicines, biologicals, vaccines, traditional medicines (obat tradisional / jamu), health supplements, cosmetics and processed food. BPOM was established as an independent Non-Ministerial Government Institution (LPNK) reporting directly to the President under Presidential Regulation 80/2017 (replacing earlier arrangements dating to 2001), operating from Jakarta with 33 provincial offices across the archipelago.

BPOM is a PIC/S member since 2012 and reached WHO Maturity Level 3 for medicines regulation in 2019. Registration follows the ASEAN Common Technical Dossier (ACTD) format for generics with ICH CTD accepted for innovator products, and BPOM operates a reliance pathway for reference-authority approvals (FDA, EMA, MHRA, Health Canada, TGA, Swissmedic, PMDA). Medical devices are regulated by a separate directorate under the Ministry of Health (Kemenkes) under the ASEAN Medical Device Directive (AMDD) framework, not by BPOM.

Since Law No. 33 of 2014 on Halal Product Assurance and its 2019 implementing regulations, most food, cosmetic and medicine products in Indonesia require halal certification from BPJPH working with LPH assessors — running in parallel with BPOM registration. GMP inspections of overseas manufacturers are risk-based; PIC/S / EU / FDA GMP certificates support desk review, while biologicals, sterile products, vaccines and traditional-medicine facilities attract on-site inspection. V5 Ultimate maps directly onto BPOM expectations — bound e-signatures, ALCOA+ batch records, deviation/CAPA workflow, halal batch-integrity controls, and a per-country dossier pack — with the paired guide at /glossary/indonesia-bpom.