Abstract

DOSSIER PREPARATION REQUIREMENTS FOR GENERIC DRUGS OF USA, EUROPE AND INDIA

D. Anantha Lakshmi*, M. V. Nagabhushanam and G. Ramakrishna

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Abstract

The main aim of the topic to review and compare the compile finished pharmaceuticals dossier for three different countries like India (CDSCO), USA (FDA) & Europe (EMA) filing process and different aspects of approval between USFDA (United States Food and Drug Administration), EMA (European Medical Agency), and DCGI (Drug Controller General of India) approval’s for marketing authorization of a drug in US, EUROPE & INDIA, and their role in improving the standard laid down by them. Approval and authorization of drug product in United States, Europe & India are the most crucial ones compare to other countries in the world. Various countries have different guidelines and standard for registration and authorization of generic drugs. The primary purpose of the rules governing medicinal products in US, Europe & India is to safeguarded public health. It is the role of public regulations so that safe and effective medications reach the market.

Keywords: India (CDSCO), USA (FDA) & Europe (EMA) Guidelines, Regulatory Requirements.