Regulatory Reform and Policy Mapping in Indonesia’s Traditional Medicine, Health Supplement, and Cosmetic Sectors
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Submitted
3 October 2025
Published
30 November 2025
Keywords:
-
Cosmetics, Health Supplements, Innovation-Driven Governance, Regulatory Reform, Traditional Medicines
Abstract
This study systematically analyzed Indonesia's regulatory reforms for traditional medicines, health supplements, and cosmetics (TMHSC) issued between 2020 and 2024. The objective was to map the scope, distribution, and policy orientation of the 35 regulations enacted by the Indonesian Food and Drug Authority (BPOM) within the framework of the National Medium-Term Development Plan (RPJMN 2020–2024). A qualitative policy analysis was employed, combining document analysis, thematic coding, and comparative benchmarking with frameworks from the ASEAN, European Union (EU), and Organisation for Economic Co-operation and Development (OECD). The findings show that 25 regulations were directed toward strengthening regulatory services, nine targeted compliance and Good Manufacturing Practices (GMP), and one supported research and innovation through preclinical testing standards. This distribution reflects a policy trajectory that prioritizes service delivery and compliance assurance, while progressively integrating evidence-based approaches to research and innovation. A comparative analysis revealed a strong alignment with ASEAN harmonization initiatives and an incremental adoption of international benchmarks, such as ISO 22716 for cosmetics and the WHO GMP guidelines for herbal medicines. Overall, Indonesia's TMHSC regulatory transformation demonstrates a balanced and adaptive governance model that safeguards public health, promotes innovation, and enhances regional policy coherence. The results provide practical implications for policymakers, particularly BPOM and ASEAN member states, in developing regulatory frameworks that effectively balance consumer protection, innovation enablement, and market competitiveness within the TMHSC sectors.
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6. Budiyoko B, Zulkifli L, Dharmawan B, Sunendar S, Rachmah MA, Prasetyo K, et al. Unlocking the sustainable livelihoods strategy for forest communities in the southern slope of Mount Slamet, Indonesia. Sustain Debate. 2024;15(1):216–32. DOI: 10.18472/SustDeb.v15n1.2024.52568
7. Cahyaningsih R, Brehm JM, Maxted N. Setting the priority medicinal plants for conservation in Indonesia. Genet Resour Crop Evol. 2021;68(5):2019–50. DOI: 10.1007/s10722-021-01115-6
8. Wirabuana PYAP, Baskorowati L, Pamungkas B, Mulyana B, South J, Purnobasuki H, et al. Mangroves, fauna compositions and carbon sequestration after ten years restoration on Flores Island, Indonesia. Sci Rep. 2025;15(1):4866. DOI: 10.1038/s41598-025-87307-x
9. Ahn S, Zhou J, Jiang D, Kerr S, Zhu Y, Song P, et al. WHO global research priorities for traditional, complementary, and integrative (TCI) medicine: an international consensus and comparisons with LLMs. J Glob Health. 2025;15:04336. DOI: 10.7189/jogh.15.04336; PMCID: PMC12615007; PMID: 41232122.
10. Gafner S, Blumenthal M, Foster S, Cardellina JH 2nd, Khan IA, Upton R. Botanical Ingredient Forensics: Detection of Attempts to Deceive Commonly Used Analytical Methods for Authenticating Herbal Dietary and Food Ingredients and Supplements. J Nat Prod. 2023;86(2):460-72. doi: 10.1021/acs.jnatprod.2c00929; PMCID: PMC9972475; PMID: 36716213
11. Ichim MC, de Boer HJ. A Review of Authenticity and Authentication of Commercial Ginseng Herbal Medicines and Food Supplements. Front Pharmacol. 2021;11:612071. DOI: 10.3389/fphar.2020.612071; PMCID: PMC7832030; PMID: 33505315
12. Kozhuharov VR, Ivanov K, Karcheva-Bahchevanska D, Prissadova N, Ivanova S. Development and Validation of Gas Chromatography–Mass Spectrometry Method for Quantification of Sibutramine in Dietary Supplements. Processes. 2023;11(8):2337. DOI: 10.3390/pr11082337
13. Wierzejska RE. Dietary Supplements—For Whom? The Current State of Knowledge about the Health Effects of Selected Supplement Use. Int J Environ Res Public Health. 2021;18(17):8897. DOI: 10.3390/ijerph18178897; PMCID: PMC8431076; PMID: 34501487
14. Gupta V, Mohapatra S, Mishra H, Farooq U, Kumar K, Ansari M, et al. Nanotechnology in Cosmetics and Cosmeceuticals—A Review of Latest Advancements. Gels. 2022;8(3):173. DOI: 10.3390/gels8030173; PMCID: PMC8951203; PMID: 35323286
15. Sharma A, Agarwal P, Sebghatollahi Z, Mahato N. Functional Nanostructured Materials in the Cosmetics Industry: A Review. ChemEngineering. 2023;7(4):66. DOI: 10.3390/chemengineering7040066
16. Kumar V, Kumar N, Singh G. Natural Products and Derivatives Applied for Skin Care: An Updated Review. Curr Tradit Med. 2024;10(1):e180123212858. DOI: 10.2174/2215083809666230118141457
17. Lähteenmäki-Uutela A, Rahikainen M, Camarena-Gómez MT, Piiparinen J, Spilling K, Yang B. European Union legislation on macroalgae products. Aquac Int. 2021;29(2):487–509. DOI: 10.1007/s10499-020-00633-x
18. Necoechea-Porras PD, López A, Salazar-Elena JC. Deregulation in the Energy Sector and Its Economic Effects on the Power Sector: A Literature Review. Sustainability. 2021;13(6):3429. DOI: 10.3390/su13063429
19. Zhang L, Pham TD, Li R, Do TT. Enhancing the Sustainable Development of the ASEAN’s Digital Trade: The Impact Mechanism of Innovation Capability. Sustainability. 2025;17(4):1766. DOI: 10.3390/su17041766
20. Göttems LBD, Mollo MDLR. Neoliberalism in Latin America: effects on health system reforms. Rev Saúde Pública. 2020;54:74. DOI: 10.11606/s1518-8787.2020054001806; PMCID: PMC7371409; PMID: 32725099
21. Hajighasemi A, Oghazi P, Aliyari S, Pashkevich N. The impact of welfare state systems on innovation performance and competitiveness: European country clusters. J Innov Knowl. 2022;7(4):100236. DOI: 10.1016/j.jik.2022.100236
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Authors
1.
Kashuri M, Yanuar A. Regulatory Reform and Policy Mapping in Indonesia’s Traditional Medicine, Health Supplement, and Cosmetic Sectors. Borneo J Pharm [Internet]. 2025Nov.30 [cited 2025Dec.31];8(4):408-23. Available from: https://journal.umpr.ac.id/index.php/bjop/article/view/11055
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