INDONESIA Law and Practice Contributed by: Wincen Santoso, Muhammad Pravest Hamidi, Daniel Wiyarta Tenggara and Rizka Rahma Briliana, Santoso, Martinus & Muliawan Advocates
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices Legislation and Regulation The primary legislation governing pharmaceuti- cals and medical devices is Law No 17 of 2023 on Health ( “Law 17/2023” ). This legislation is implemented through regulations on pharma- ceuticals issued by the Indonesian Food and Drug Authority ( Badan Pengawas Obat dan Makanan , or BPOM) as well as regulations on medical devices issued by the Minister of Health (MOH). On 26 July 2024, the government issued Government Regulation (GR) No 28 of 2024 on Implementing Regulation of Law Number 17 of 2023 on Health ( “GR 28/2024” ). Pharmaceuticals Key regulations for pharmaceuticals include: • BPOM Regulation No 8 of 2024 on Proce- dures for the Approval of Clinical Trials Imple- mentation ( “BPOM 8/2024” ) • BPOM Regulation No 27 of 2022 on Supervi- sion of Drug and Food Imports into Indonesia, as amended 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 Supervision of Drugs and Food Distributed Online ( “BPOM 14/2024” ) • BPOM Regulation No 7 of 2024 on Good Manufacturing Practice for Pharmaceuticals; • BPOM Regulation No 10 of 2021 on Stand- ards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Drug and Food Sector;
• Head of BPOM Regulation No 24 of 2017 on Criteria 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 Provi- sion 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 Stand- ards for Business Activities and Products in the Implementation of Risk-Based Busi- ness Licensing in the Health Sector, as lastly amended by MOH Regulation No 17 of 2024( “MOH 14/2021” ) • MOH Regulation No 51 of 2014 on the Impor- tation of Medical Devices through the Spe- cial 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 Imple- mentation of Telemedicine Services between Healthcare Facilities ( “MOH 20/2019” ) • MOH Regulation No 62 of 2017 on Market- ing Authorisation for Medical Devices, In Vitro Diagnostic 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 Pharmaceuti- cal and Medical Equipment Industry ( “MOH 17/2017” ) • MOH Regulation No 76 of 2013 on Advertis- ing of Medical Devices and Household Health Supplies ( “MOH 76/2013” )
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