Indonesia
Badan Pengawas Obat dan Makanan (National Agency of Drug and Food Control) (BPOM)
Checked 12 September 2026. No fee amount confirmed.
4 days agoEvery marketing authorisation fee on this profile was checked against the regulator and none could be confirmed from a published schedule. The amounts previously shown here were not traceable to a source and have been removed rather than left in place. Pathways, legal basis, timelines and source links are unchanged. Use the linked authority material for any figure.
Unconfirmed amounts were deliberately removed rather than estimated.
Contributor Wilson Blaney, ACQI, RP (GDP) trained
Indonesia regulates pharmaceutical products through Badan Pengawas Obat dan Makanan (BPOM), the National Agency of Drug and Food Control. BPOM is an autonomous government agency reporting directly to the President. The legal framework rests on Law No. 17/2023 on Health, Government Regulation No. 28/2024, and BPOM Regulation No. 23/2025 (which superseded earlier registration rules and updated evaluation timelines, biological product classifications and labelling requirements). Marketing authorisation is evidenced by the Nomor Izin Edar (NIE). Indonesia is an ASEAN member that has implemented the ASEAN Common Technical Dossier (ACTD) and ACTR. BPOM operates New Drug, Generic, Biological and Variation pathways, with reliance on Stringent Regulatory Authorities (SRA) and ACTD-aligned ASEAN reference countries supporting abridged review for selected products. Indonesia is the world's largest Muslim-majority country and applies Halal certification to medicines under Law No. 33/2014 on Halal Product Assurance, with progressive enforcement deadlines administered by BPJPH (the Halal Product Assurance Agency). Public-sector reimbursement runs through JKN (Jaminan Kesehatan Nasional), the universal health insurance scheme administered by BPJS Kesehatan, with the Formularium Nasional (Fornas) as the gatekeeper for reimbursement.
About the authority
BPOM is Indonesia's national regulatory authority for medicines, biologicals, traditional medicines, health supplements, cosmetics and processed food. Within BPOM, the Deputi Bidang Pengawasan Obat (Deputy for Drug Control) administers product registration, GMP/GDP licensing, pharmacovigilance and post-market surveillance. Statutory marketing authorisation (Nomor Izin Edar, NIE) is issued by the Head of BPOM. BPOM has been a PIC/S member since 2012 and is an ICH Observer.
Reliance & recognition
BPOM recognises Stringent Regulatory Authority (SRA) approvals and WHO Prequalification for abridged review and operates ASEAN harmonisation under ACTD/ACTR and the ASEAN Joint Assessment Coordinating Group (AJACG). A complete dossier and Bahasa Indonesia administrative documentation are still required.
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