The Strategic Role of the Indonesian FDA in Empowering Micro, Small, and Medium Enterprises in the Drug and Food Sectors: A Review
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Submitted
13 October 2024
13 October 2024
Published
1 March 2025
1 March 2025
Abstract
This review examines the evolving role of the Indonesian Food and Drug Authority (BPOM) in empowering Small and Medium Enterprises (SMEs) within the pharmaceutical and food sectors. While significant strides have been made in recent years, challenges remain. These include discrepancies between regulatory objectives and the practical capabilities of SMEs, particularly in navigating complex regulatory frameworks. While digitalization initiatives and technical assistance programs have shown promise, their impact is often hindered by resource limitations and resistance to change among stakeholders. This review underscores the critical need for a balanced approach that effectively integrates regulatory oversight with targeted support for SME growth. Fostering an ecosystem that encourages innovation and ensures regulatory compliance necessitates a multi-stakeholder approach, demanding more sustainable and effective coordination among government agencies, industry associations, and academic institutions. The success of BPOM's empowerment efforts hinges on adopting flexible, technology-driven, and results-oriented strategies. Future endeavors should prioritize long-term evaluations of existing programs, develop robust metrics to assess their effectiveness and explore innovative approaches to address the evolving regulatory landscape in the digital era.
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2. Hudiyono RF, Safitri D. Analisis Program Pengembangan Usaha Mikro, Kecil, dan Menengah (UMKM) oleh PT Lima Pondasi Bersama. J Administrasi Bisnis Terapan. 2022;4(2):1. DOI: 10.7454/jabt.v4i2.1026
3. Rabbany MB. Supervision of Medicinal Products by BPOM Consumer Protection Legal Perspective (ED/DEG Tainted Syrup Drug Case). Riwayat Edu J Hist Humanit. 2023;6(4):2293-301. DOI: 10.24815/jr.v6i4.34569
4. Mahardhika IN, Widanti NPT, Widnyani IAPS, Bidul IAS. Evaluasi Kebijakan Pemerintah Terhadap Pengembangan Usaha Mikro, Kecil, dan Menengah (UMKM) di Kabupaten Badung. ECo-Buss. 2024;7(2):1229-39. DOI: 10.32877/eb.v7i2.1720
5. Wahyudi AS, Yulivan I, Rahman A. The Role of Micro, Small, and Medium Enterprises (MSMEs) in Supporting Indonesia’s Economic Resilience. J Pertahanan. 2024;10(2):297-307. DOI: 10.33172/jp.v10i2.19519
6. Wulandari R, Kenyowulan P, Juwitaningsih M, Jaffar AK. Analyzing the Impact of the Business Licensing Ease Policy for Drug and Food MSME Business Actors: a Case Study in East Kalimantan Province from 2018 to 2023. J-3P J Pembangunan Pemberdayaan Pemerintahan. 2023;8(2):150-67. DOI: 10.33701/j-3p.v8i2.3760
7. De Mattos CS, Pellegrini G, Hagelaar G, Dolfsma W. Systematic literature review on technological transformation in SMEs: a transformation encompassing technology assimilation and business model innovation. Manag Rev Q. 2023;1-39. DOI: 10.1007/s11301-023-00327-7; PMCID: PMC9950710
8. Telukdarie A, Dube T, Matjuta P, Philbin S. The opportunities and challenges of digitalization for SME's. Proced Comp Sci. 2023;217:689-98. DOI: 10.1016/j.procs.2022.12.265
9. Lukas EN, Hasudungan A. The Impact of the Digital Divide on MSMEs’ Productivity in Indonesia. Int Res J Bus Stud. 2024;16(3):241-52. DOI: 10.21632/irjbs.16.3.241-252
10. Gusenbauer M, Haddaway NR. Which academic search systems are suitable for systematic reviews or meta-analyses? Evaluating retrieval qualities of Google Scholar, PubMed, and 26 other resources. Res Synth Methods. 2020;11(2):181-217. DOI: 10.1002/jrsm.1378; PMCID: PMC7079055; PMID: 31614060
11. Badan Pengawas Obat dan Makanan Republik Indonesia. Peraturan Badan Pengawas Obat dan Makanan Nomor 22 Tahun 2020 tentang Organisasi dan Tata Kerja Unit Pelaksana Teknis di Lingkungan Badan Pengawas Obat dan Makanan. Jakarta: Badan Pengawas Obat dan Makanan Republik Indonesia; 2020. Available from: https://jdih.pom.go.id/download/flip/1187/22/2020
12. Putri RA. Development of Digital Registration Information System in Kelurahan to Improve Administration Efficiency and Transparency. Inf Technol Syst. 2024;1(2):92-9. DOI: 10.58777/its.v1i2.198
13. Rosyidiana RN, Narsa IM. Micro, small, and medium-sized enterprises (MSMEs) during the post-pandemic economic recovery period: digitalization, literation, innovation, and its impact on financial performance. Cogent Bus Manag. 2024;11(1):2342488. DOI: 10.1080/23311975.2024.2342488
14. Feng K, Miranda AV, Obnial JC, Ebhodaghe ID, Lucero-Prisno III DE. Drug regulatory harmonization in the Association of Southeast Asian Nations: Is it time for an ASEAN medicines agency? A policy review. Clin Epidemiol Glob Health. 2024;28:101649. DOI: 10.1016/j.cegh.2024.101649
15. Lestari TRP. Keamanan Pangan Sebagai Salah Satu Upaya Perlindungan Hak Masyarakat Sebagai Konsumen. Aspirasi J Masalah Masalah Sosial. 2020;11(1):57-72. DOI: 10.46807/aspirasi.v11i1.1523
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Authors
1.
Kashuri M, Ikrar T. The Strategic Role of the Indonesian FDA in Empowering Micro, Small, and Medium Enterprises in the Drug and Food Sectors: A Review. Borneo J Pharm [Internet]. 2025Mar.1 [cited 2025Mar.27];8(1):1-14. Available from: https://journal.umpr.ac.id/index.php/bjop/article/view/8432
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