Indonesia

Health product regulation in Indonesia is overseen by BPOM (Badan Pengawas Obat dan Makanan), established under Government Regulation No. 80 of 2017 and further empowered by the Omnibus Law (Law No. 11 of 2020) and its implementing regulations. BPOM is responsible for the pre-market evaluation, registration, and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and certain digital health tools. Medical devices and in vitro diagnostics (IVDs) fall under a parallel regulatory framework administered jointly by BPOM and the Ministry of Health (Kementerian Kesehatan, Kemenkes) under Regulation No. 62 of 2017, which established a risk-based classification system (Class A through D) analogous to international standards. Pharmaceuticals require a Marketing Authorization (Izin Edar) from BPOM prior to commercialization, and review timelines vary significantly by product class, registration pathway (new, generic, or simplified), and submission completeness.

Foreign manufacturers seeking market authorization in Indonesia must appoint a local registered entity, typically a licensed importer or distributor, to act as the Marketing Authorization Holder (MAH) and submit registration dossiers on their behalf. Indonesia accepts dossiers formatted according to the ASEAN Common Technical Dossier (ACTD) standard, and increasing alignment with ICH Common Technical Document (CTD) format is being pursued for pharmaceutical submissions. BPOM has implemented an e-registration portal to streamline submissions and improve transparency. Notable recent reforms include the introduction of accelerated pathways for priority and emergency-use products following the COVID-19 pandemic, enhanced post-market surveillance requirements, and growing digitalization of regulatory processes under BPOM's 2020-2024 strategic roadmap. Indonesia is also progressively harmonizing its regulatory framework with ASEAN Mutual Recognition Arrangements (MRAs) to reduce redundant testing requirements for products already approved by recognized reference agencies.

Public procurement of health products in Indonesia is governed by a multi-layered structure involving the Ministry of Health (Kemenkes), the National Government Goods and Services Procurement Agency (LKPP, Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah), and regional government bodies. At the national level, strategic health commodities such as vaccines, essential medicines, and contraceptives are procured centrally by Kemenkes through national tender processes administered in accordance with Presidential Regulation No. 16 of 2018 on Government Procurement. The national health insurance scheme, Jaminan Kesehatan Nasional (JKN), managed by BPJS Kesehatan, is a major driver of formulary-based procurement and reimbursement decisions. Products must be listed on the National Formulary (Formularium Nasional, Fornas) and the e-Catalogue (e-Katalog) managed by LKPP to be eligible for JKN-funded procurement. At the subnational level, provincial and district health offices (Dinas Kesehatan) manage procurement for regional hospitals and community health centers (Puskesmas), creating a decentralized procurement landscape that can vary considerably by region.

The private sector represents a substantial and growing share of health product consumption in Indonesia, accessed through licensed distributors, hospital procurement committees, retail pharmacy chains, and independent pharmacies. International donor and multilateral channels also play a meaningful role, particularly for communicable disease programs: the Global Fund supports HIV, tuberculosis, and malaria commodity procurement; Gavi finances vaccine introduction and supply chain strengthening; and USAID provides technical assistance and commodity support through programs such as SIAP and the Global Health Supply Chain initiative. UNICEF Supply Division is active in maternal and child health commodity provision. Indonesia has established explicit local manufacturing preference policies under the Made in Indonesia (Tingkat Komponen Dalam Negeri, TKDN) framework, which requires a minimum percentage of domestic content for government procurement eligibility. Imported health products may face restrictions or pricing disadvantages in public tenders, creating strong incentives for technology transfer agreements and local manufacturing partnerships to improve market access.