REGULATORY STRATEGIES FOR FILING OF NDA IN ICH COUNTRIES (US, EUROPE and JAPAN)
Journal Title: International Journal of Pharmaceutical Development & Technology - Year 2015, Vol 5, Issue 2
Abstract
ABSTRACT Developing new drugs requires great amount of research work in Chemistry, Manufacturing, Controls, preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, efficacy and quality control of a new drug product to serve the public health. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. This article focuses on drug approval process in different countries like USA, Europe and Japan. Keywords: MAA, USFDA, Drug approval process, Clinical Trial.
Authors and Affiliations
Priyanka Gangarapu, P. Jayachandra Reddy, M. Alagu Sundaram, M. Sabareesh, V. Prabhakaran
Keywords
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