Abstract

A COMPARITIVE STUDY OF THE DRUG APPROVAL PROCESS IN USA, INDIA, JAPAN AND EUROPE

Akhilesh Chandra* and Bhumika Kumar

Abstract

Safety and efficacy of a drug product for use in humans is essential before the drug product can be approved for import or manufacturing a new drug. For this every country has its regulatory authority that bears the responsibility of evaluating whether the research data of new drug/product supports the safety and efficacy to serve public health. Regulatory affair department of a company plays a vital role of working in accordance to the rules, regulations and guidelines established by the regulating agencies of different countries. This article aims to compare different aspects of drug approval process in USA, Europe, India and Japan.

Keywords: FDA, EMA, PMDA, CDSCO, MAA, NDA, INDA, ANDA.