Drug approval process in India and Europe

  • S P Yamini Kanti
  • Ildiko Csoka
  • Amrish Chandra
  • Vikesh Kumar Shukla

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.

Keywords: Drug approval, Clinical Trial, MAA, CDSCO, Centralized procedure, Mutual recognition procedure, Decentralized procedure, National procedure

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How to Cite
Kanti, S. P., I. Csoka, A. Chandra, and V. Shukla. “Drug Approval Process in India and Europe”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 1, Mar. 2019, pp. 34-40, doi:https://doi.org/10.22270/ijdra.v7i1.304.