Copyright (c) 2026 B. Anjitha Jasmine, A. Eshwar
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Comparative Study of Dossier Submission Requirements for Anda in India Versus EMA
Corresponding Author(s) : B. Anjitha Jasmine
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 14 No. 2 (2026): 2026 Volume -14 - Issue 2
Abstract
This study compares the dossier submission requirements for Abbreviated New Drug Applications (ANDAs) in India and the European Medicines Agency (EMA) framework. Both regulatory authorities follow the Common Technical Document (CTD) format established by the International Council for Harmonisation (ICH); however, regional variations persist in administrative, technical, and procedural requirements.
In India, the Central Drugs Standard Control Organization (CDSCO) oversees ANDA submissions under the New Drugs and Clinical Trials Rules (NDCTR, 2019), emphasizing Zone IVb stability data, local bioequivalence studies, and API source verification. In contrast, the EMA mandates electronic CTD (eCTD) submissions, standardized review timelines, and publication of European Public Assessment Reports (EPARs) for transparency.
Despite structural similarities, key differences exist in dossier evaluation models, digital maturity, and reliance practices. India’s system remains flexible and locally adaptive, whereas the EMA’s framework demonstrates greater procedural standardization. The study concludes that enhanced regulatory convergence, digitalization, and mutual recognition mechanisms could streamline generic drug approvals globally.