Indonesia

In Indonesia, the primary regulatory authority for health products is BPOM (Badan Pengawas Obat dan Makanan), established under Government Regulation No. 80 of 2017 and operating under Presidential Regulation No. 80 of 2017. BPOM is responsible for the pre-market evaluation and post-market surveillance of pharmaceuticals, medical devices, diagnostics, and related health products. Medical devices and in vitro diagnostics are additionally governed under the Ministry of Health (Kementerian Kesehatan, Kemenkes) framework, particularly through Ministerial Regulation No. 62 of 2017 on medical device licensing. All health products must obtain a marketing authorization (Izin Edar) before they may be commercially distributed in Indonesia, and products are classified into risk-based categories that determine the depth of technical review required.

Applicants must appoint a local Indonesian legal entity as the registered license holder, as foreign manufacturers cannot apply directly. Dossiers are generally submitted following the ASEAN Common Technical Dossier (ACTD) format for pharmaceuticals, while medical devices follow ASEAN Medical Device Directive (AMDD) guidelines. Indonesia is a member of the ASEAN Medical Device Directive framework and participates in mutual recognition discussions, although full harmonization remains in progress. BPOM has pursued several notable reforms in recent years, including the introduction of an online submission portal (e-registration) to streamline application processing, accelerated pathways for priority medicines and products addressing unmet medical needs, and enhanced post-market vigilance obligations. Import approvals and Good Manufacturing Practice (GMP) certification requirements from the country of origin are typically mandatory components of a complete submission.

Public procurement in Indonesia is centralized at the national level through the Ministry of Health (Kemenkes), which coordinates national formulary listings and essential medicines procurement via the National Health Insurance program (Jaminan Kesehatan Nasional, JKN), administered by BPJS Kesehatan. Procurement is conducted through the government e-procurement platform LPSE (Layanan Pengadaan Secara Elektronik) under the oversight of LKPP (Lembaga Kebijakan Pengadaan Barang/Jasa Pemerintah), the National Public Procurement Policy Agency. Products intended for public hospital and primary healthcare center (Puskesmas) supply chains must be listed on the national formulary (Formularium Nasional, Fornas) and comply with government price ceilings set through the Ministry of Health Drug Price Reference (e-Katalog). Provincial and district-level health offices retain some autonomy for local procurement, particularly for non-formulary products, resulting in a layered federal-regional procurement dynamic that manufacturers must navigate carefully.

The private sector represents a significant and growing channel in Indonesia, served by a network of private hospitals, pharmacy chains, and independent clinics, with procurement managed through distributors holding local authorization. International donor-funded channels, including UNICEF, the Global Fund (for HIV, tuberculosis, and malaria commodities), Gavi (for vaccines), and USAID-supported programs, operate alongside government procurement and often follow their own procurement standards and supplier qualification processes. Indonesia has an explicit local manufacturing preference policy under Government Regulation No. 29 of 2018 on industrial development, encouraging domestic production of pharmaceuticals and medical devices. Products manufactured locally or under licensed local production arrangements may receive preferential consideration in public tenders, and the government has set targets to increase domestic self-sufficiency in essential health products, making local partnerships or technology transfer arrangements strategically important for international manufacturers.