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International Journal of Zoology and Applied Biosciences Research Article
A comparative study of regulatory requirements and procedures of the EU, Canada and India
Rajkiran Kolakota, Uriti Sri Venkatesh, Kornu Manjulatha, Anand Singh
Year : 2026 | Volume: 11 | Issue: 5 | Pages: 56-59
Received on: 25/05/2026
Revised on: 10/06/2026
Accepted on: 12/07/2026
Published on: 01/09/2026
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Rajkiran Kolakota, Uriti Sri Venkatesh, Kornu Manjulatha, Anand Singh( 2026).
A comparative study of regulatory requirements and procedures of the EU, Canada and India
. International Journal of Zoology and Applied Biosciences, 11( 5), 56-59.
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Abstract
The regulatory landscape for pharmaceuticals plays a pivotal role in ensuring quality, safety, and efficacy of medicines. The European Union (EU), Canada, and India are major players with distinct regulatory frameworks. This study conducts a comparative analysis of the regulatory requirements and procedures for pharmaceutical approvals across these jurisdictions. It explores dossier formats, clinical data requirements, bioequivalence standards, timelines, pharmacovigilance obligations, and reliance pathways. The findings highlight differences in harmonization, reliance on international guidelines, timelines, and post-approval obligations, underscoring opportunities for cooperation and convergence. The study concludes with recommendations for regulatory efficiency and public health alignment.
Keywords
Quality, Safety, Pathways, Public health, Canada, India.
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© The Author(s) 2026. 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.
