Drug approval process in India and Europe
Journal Title: International Journal of Drug Regulatory Affairs - Year 2019, Vol 7, Issue 1
Abstract
Every time a new drug is developed it requires a great amount of research work in manufacturing, Pre- clinical Science, Controls, Chemistry & Clinical trials. Regulatory agencies have Drug Reviewers who has the responsibility of checking that whether the data supports the Safety, Effectiveness and Quality control of a New Drug product to serve the public health. Every country has its own Regulatory agency which is responsible for regulating all the Rules and Regulations and forms the guidelines for regulating the Manufacturing, Processing and Marketing of the Drugs. This Article focuses on Drug Approval Process in Europe and India.
Authors and Affiliations
S P Yamini Kanti, Ildiko Csoka, Amrish Chandra, Vikesh Kumar Shukla
Keywords
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- EP ID EP495760
- DOI 10.22270/ijdra.v7i1.304
- Views 109
- Downloads 0
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