Comparative Study of Regulatory Requirement and Approval Process for Drugs in India, US and Europe
Abstract
This review conducts a comparative analysis of drug approval for new and generic medicines across three jurisdictions: United States (US FDA), India (CDSCO), and the European Union (EMA) framed as a three-stage process (application, review, approval) and focusing on regulatory pathways, statutory timelines, documentation requirements, and application costs; it also compares review timelines and application costs across the three agencies. Primary data were gathered from official regulatory documents, guidelines, fee schedules, and the FDA, CDSCO (India), and EMA (current through mid-2025) agencies' websites. Secondary market data were procured from authoritative industry reports. Systematic search and cross verification of primary sources, taking into consideration the US Code of Federal Regulations (Titles 21 and 42), New Drugs and Clinical Trials Rules of India 2019, applicable rules, and Directives of the EU and procedural manuals of each agency. All jurisdictions, operationally, follow a three-stage approval process. The US FDA has high application costs, a 10-month standard review time, and many expedited pathways. India's CDSCO has low application costs, a prescribed 90-day review with a deemed-approval mechanism, and frequent waivers of local trials. The EMA's centralised procedure has an average lead time of 277 days and provides significant fee reductions to small companies and orphan drugs. All three use the eCTD for submissions, but the administrative details and form requirements differ.
Conclusion: Jurisdictional strategies are reflective of distinct priorities: the priority of the US for rigorous evaluation in high-value markets, the incentives of Europe for specialised therapies, and the priority of India on efficiency and cost-effectiveness are essential for drug development across the globe.
Keywords:
drug approval, regulatory science, US FDA, CDSCO, European Medicines Agency, review timelines, marketing authorisation
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References
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Shirole SA, Ali SS. Comparative Study of Regulatory Requirement and Approval Process for Drugs in India, US and Europe. Int J Drug Reg Affairs [Internet]. 2026Sep.15 [cited 2026Sep.17];14(3):1-17. Available from: https://www.ijdra.com/index.php/journal/article/view/805
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