Abstract

MARKETING AUTHORIZATION OF PHARMACEUTICALS IN UNITED STATES (US), EUROPEAN UNION (EU) AND INDIA

Imran A. W. Sheikh*, Neha V. Ramteke, Jayprakash N. Gayakwad, Rutuja A. Dhore, Nishant D. Andelkar, Dr. Ajay G. Pise

ABSTRACT

Marketing authorization is a regulatory process that ensures pharmaceutical products meet standards of safety, efficacy, and quality before market entry. This article compares the marketing authorization procedures in the United States, European Union, and India. The United States follows IND and NDA/ANDA pathways regulated by the FDA, while the European Union provides centralized, decentralized, mutual recognition, and national procedures coordinated by the EMA. In India, approvals are granted by CDSCO/DCGI under the Drugs and Cosmetics Act, 1940, based on clinical and non-clinical data submission. Despite differences in regulatory frameworks, all regions require CTD/eCTD dossier submission and emphasize clinical evaluation and post-marketing surveillance. Understanding these procedures helps in developing effective global regulatory strategies and facilitating timely drug approvals across major markets.

Keywords: Marketing Authorization, Investigational New Drug, New Drug Application, Centralized Procedure, Decentralized Procedure, Mutual Recognition Procedure, Drug and Cosmetics act 1940, Clinical Trails, Drug Development, USFDA, EMA, CDSCO.