Abstract

COMPARATIVE STUDY OF REGULATORY REQUIREMENTS FOR DRUG APPROVAL PROCESS IN UNITED STATE, INDIA AND EUROPE UNION

Priyanka Padole*, Prof. (Dr.) M.A. Channawar, Prof. (Dr.) A. V. Chandewar

Abstract

The approval process for pharmaceutical drugs is important for ensuring safety, effectiveness, and quality of medicines prior to their commercialization. Every country has its own regulatory process based on science, law, and health care needs. This review gives an assessment of the regulatory requirements and the approval process adopted in the USA, EU, and India regulated by USFDA, EMA, and CDSCO respectively. Comparative assessment is made of the requirements for conducting clinical trials, submission of dossiers, pharmacovigilance programs, and review periods. Harmonization efforts are also assessed in the context of ICH and CTD. The USA follows a stringent centralized path through IND, NDA, ANDA, and BLA approvals. The EU operates under centralized, decentralized, mutual recognition, and national approaches coordinated by EMA. India has improved its regulation process through NDCTR 2019 and harmonizing with international practices.

Keywords: USFDA, EMA, CDSCO, CTD, Drug Approval Process, Clinical Trials, Regulatory Affairs, Pharmacovigilance.