INDONESIA Law and Practice Contributed by: Wincen Santoso and Muhammad Pravest Hamidi, Santoso, Martinus & Muliawan Advocates
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation Legislation and Regulation The primary legislation governing pharmaceuticals and medical devices is Law No 17 of 2023 on Health, as amended by Law No 1 of 2026 (“Law 17/2023 as amended”). This legislation is implemented through Government Regulation (GR) No 28 of 2024 on Imple- menting Regulation of Law Number 17 of 2023 on Health (“GR 28/2024”). Further technical provisions are found in various regulations on pharmaceuticals issued by the Indonesian Food and Drug Authority ( Badan Pengawas Obat dan Makanan , or BPOM) and regulations on medical devices issued by the Minister Key regulations for pharmaceuticals include: • BPOM Regulation No 8 of 2024 on Procedures for the Approval of Clinical Trials Implementation as amended by BPOM Regulation No 34 of 2025 (“BPOM 8/2024 as amended”); of Health (MOH). Pharmaceuticals • BPOM Regulation No 27 of 2022 on Supervision of Drug and Food Imports into Indonesia, as amend- ed by BPOM Regulation No 28 of 2023 (“BPOM 27/2022 as amended”); • BPOM Regulation No 2 of 2021 on Guidelines for Drug Advertising Supervision (“BPOM 2/2021”); • BPOM Regulation No 14 of 2024 on the Supervi- sion of Drugs and Food Distributed Online, as amended by BPOM Regulation No 30 of 2025 (“BPOM 14/2024 as amended”); • BPOM Regulation No 7 of 2024 on Good Manufac- turing Practice for Pharmaceuticals, as amended by BPOM Regulation No 7 of 2025; • BPOM Regulation No 27 of 2025 on Standards for Business Activities and Products in the Imple- mentation of Risk-Based Business Licensing in the Drug and Food Subsector (“BPOM 27/2025”); • Head of BPOM Regulation No 24 of 2017 on Cri- teria and Procedures for Drug Registration, as last amended by BPOM Regulation No 15 of 2023 (“H. BPOM 24/2017 as amended”); and • MOH Regulation No 98 of 2015 on the Provision of Information on Maximum Retail Price of Medicines (“MOH 98/2015”).
Medical devices Key regulations for medical devices include: • MOH Regulation No 14 of 2021 on Standards for Business Activities and Products in the Implemen- tation of Risk-Based Business Licensing in the Health Sector, as lastly amended by MOH Regula- tion No 17 of 2024 (“MOH 14/2021”); • MOH Regulation No 11 of 2025 on Standards for Business Activities and Products in the Implemen- tation of Risk-Based Business Licensing in the Health Subsector (“MOH 11/2025”); • MOH Regulation No 51 of 2014 on the Importation of Medical Devices through the Special Access Scheme as amended by MOH Regulation No 7 of 2020 (“MOH 51/2014 as amended”); • MOH Regulation No 24 of 2022 on Medical Records (“MOH 24/2022”); • MOH Regulation No 20 of 2019 on the Implemen- tation of Telemedicine Services between Health- care Facilities (“MOH 20/2019”); • MOH Regulation No 62 of 2017 on Marketing Authorisation for Medical Devices, In Vitro Diag- nostic Medical Devices, and Household Health Supplies (“MOH 62/2017”); • MOH Regulation No 63 of 2017 on Good Clinical Practice for Medical Devices (“MOH 63/2017”); • MOH Regulation No 17 of 2017 on Action Plan for the Development of the Pharmaceutical and Medi- cal Equipment Industry (“MOH 17/2017”); • MOH Regulation No 76 of 2013 on Advertising of Medical Devices and Household Health Supplies (“MOH 76/2013”); • MOH Regulation No 20 of 2017 on Good Manufac- turing Practices for Medical Devices and House- hold Health Supplies (“MOH 20/2017”); • MOH Regulation No 1189/MENKES/PER/VIII/2010 of 2010 on Production of Medical Devices and Household Health Supplies (“MOH 1189/2010”); and • MOH Regulation No 4 of 2014 on Good Distribu- tion Practice for Medical Devices (“MOH 4/2014”). Regulatory Bodies Pharmaceuticals The BPOM is the primary regulatory body responsible for the supervision and regulation of pharmaceuticals in Indonesia. The BPOM operates under Presidential
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