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International Journal of Zoology and Applied Biosciences Research Article
A comparative study of regulatory approaches of asean countries for approval of generic pharmaceutical products
Rajkiran Kolakota, Uriti Sri Venkatesh, Kornu Manjulatha, Adingi Yamini
Year : 2026 | Volume: 11 | Issue: 4 | Pages: 187-191
Received on: 30/04/2026
Revised on: 28/05/2026
Accepted on: 22/06/2026
Published on: 01/07/2026
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Rajkiran Kolakota, Uriti Sri Venkatesh, Kornu Manjulatha, Adingi Yamini( 2026).
A comparative study of regulatory approaches of asean countries for approval of generic pharmaceutical products
. International Journal of Zoology and Applied Biosciences, 11( 4), 187-191.
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Abstract
Generic pharmaceutical products play a crucial role in improving access to affordable medicines, particularly in developing and emerging economies. The Association of Southeast Asian Nations (ASEAN) represents a rapidly expanding pharmaceutical market with diverse regulatory systems governing the approval of generic drugs. Although ASEAN has undertaken several harmonization initiatives, including the ASEAN Common Technical Dossier (ACTD) and ASEAN Common Technical Requirements (ACTR), significant regulatory differences persist among member states. This study aims to compare the regulatory approaches adopted by selected ASEAN countries for the approval of generic pharmaceutical products. A descriptive and comparative analysis was conducted using regulatory guidelines, official publications, and secondary literature from national regulatory authorities, ASEAN bodies, and the World Health Organization (WHO). The findings indicate partial harmonization in dossier format and quality requirements; however, variations remain in bioequivalence requirements, approval timelines, and post-approval regulatory controls. Strengthening regulatory reliance mechanisms and further harmonization could enhance access to generic medicines across the ASEAN region.
Keywords
Generic drugs, ASEAN, Regulatory harmonization, ACTD, Bioequivalence, Drug approval.
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© The Author(s) 2025. This article is published by International Journal of Zoology and Applied Biosciences under the terms of the Creative Commons Attribution 4.0 International License (creativecommons.org), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
