A REVIEW ON DRUG APPROVAL PROCESS FOR US, EUROPE AND INDIA
Journal Title: International Journal of Drug Regulatory Affairs - Year 2014, Vol 2, Issue 1
Abstract
Developing a new drug 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, effectiveness 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 India.
Authors and Affiliations
Prajapati Vishal, Goswami Rahulgiri, Makvana Pratik, Badjatya Jitendra Kumar
Keywords
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