• P.Rakesh
• Adilakshmi. Ch
• M.V.Nagabhushanam
• Sk.Sanjuda
• G.Rama Krishna

In order to guarantee that the general population has access to safe and reasonably priced medications, the pharmaceutical sector is essential. Since generic pharmaceuticals are less expensive than branded ones, they must follow stringent legal requirements to ensure their quality, safety, and effectiveness.With an emphasis on the Common Technical Document (CTD) format, this comparative study examines the generic medicine approval procedure and registration requirements in Europe, the USA, and India. The study investigates the regulatory frameworks of the Central Drugs Standard Control Organization (CDSCO), the US Food and Drug Administration (USFDA), and the European Medicines Agency (EMA) in India. The dossier preparation procedure, bioequivalence analyses, filing schedules, and post-approval procedures are important factors. Highlighted are variations in administrative practices, harmonization initiatives under the International Council for Harmonization (ICH), and difficulties unique to each region. In the end, the results hope to improve patient access to reasonably priced healthcare solutions by offering guidance to pharmaceutical companies navigating the global regulatory environment and encouraging streamlined procedures for quicker generic medicine market launch. deadlines for filing and post-approval specifications.

Generic drugs, Common Technical Document (CTD) format, Europe, the USA, and India, European Medicines Agency (EMA), the United States Food and Drug Administration (USFDA), and the Central Drugs Standard Control Organization (CDSCO).

"COMPARATIVE STUDY OF THE GENERIC DRUG APPROVAL PROCEDURE AND REGISTRATION IN EUROPE, THE UNITED STATES, AND INDIA IN COMPLIANCE WITH CTD", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 11, page no.b66-b70, November-2025, Available :http://www.jetir.org/papers/JETIR2511108.pdf

"COMPARATIVE STUDY OF THE GENERIC DRUG APPROVAL PROCEDURE AND REGISTRATION IN EUROPE, THE UNITED STATES, AND INDIA IN COMPLIANCE WITH CTD", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 11, page no. ppb66-b70, November-2025, Available at : http://www.jetir.org/papers/JETIR2511108.pdf