Library / regulatory-reference
Indonesia: National Agency of Drug and Food Control (BPOM)
Audience: administrators-policy, researchers-scientists ยท Review state: published
The national authority
The National Agency of Drug and Food Control, known as BPOM, is Indonesia's national regulator for medicines, traditional medicines, cosmetics, food supplements and processed food, reporting directly at the national level.
Indonesia is the largest market in Southeast Asia, and BPOM's remit reflects the country's particular mix: conventional pharmaceuticals alongside a large traditional-medicine sector, known as jamu, which the agency registers and supervises under its own category.
How products enter the market
Medicines require marketing authorization following evaluation of quality, safety and efficacy, with requirements for local clinical or bridging data in defined cases. Generic medicines follow bioequivalence-based assessment, and traditional medicines and supplements have their own registration tracks with distinct evidence expectations.
Medical devices require registration with risk-based classification, and BPOM operates pre-market evaluation alongside post-market surveillance and laboratory testing across the archipelago.
Regional and international role
BPOM is a leading authority within Southeast Asian harmonization work and has been strengthening its systems toward international maturity benchmarks, with particular attention to vaccine and biological-product oversight given Indonesia's large immunization program.
The agency also coordinates halal-related expectations for health products in cooperation with the country's religious authorities, a distinctive feature of the Indonesian market.
Using this profile
BPOM publishes registers, guidance and announcements in Indonesian through its official portal, which is the primary source for current rules and listed in this profile's internal reference record.
For cross-country comparison: BPOM illustrates the large-archipelago regulator managing conventional and traditional medicine markets side by side, with registration tracks adapted to each and a growing reliance on international harmonization.
Limitations
Educational profile of a national regulatory system, current as of drafting. It simplifies routes and classes and is not legal, regulatory, or clinical advice. Filing and compliance decisions must be confirmed against the authority's current published rules and, where needed, professional regulatory counsel.