1Department Of Drug Regulatory Affairs, Amity Institute of Pharmacy, Amity University, Sector-125, Noida (UP), India
2Head of Institute, Institute of Pharmaceutical Technology and Regulatory Affairs, Szeged University, Szeged, Hungary
*Corresponding author Tel.: +91-9205334134; E-mail address: yaminikanti3@gmail.com (S P Yamini Kanti).
Online published on 17 September, 2019.
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.
Drug approval, Clinical Trial, MAA, CDSCO, Centralized procedure, Mutual recognition procedure, Decentralized procedure, National procedure
