TY - JOUR AU - S P Yamini Kanti AU - Ildiko Csoka AU - Amrish Chandra AU - Vikesh Kumar Shukla PY - 2019/03/16 Y2 - 2024/03/29 TI - Drug approval process in India and Europe JF - International Journal of Drug Regulatory Affairs JA - Int J Drug Reg Affairs VL - 7 IS - 1 SE - Review DO - 10.22270/ijdra.v7i1.304 UR - https://ijdra.com/index.php/journal/article/view/304 AB - 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. ER -