Monday , 28 September 2020

An Evaluation and Comparative Study of Regulatory of Regulatory Requirements for Registration of Generic injectables in USA, European Union and Canada

D.S. Naveen Kumar*1, J. Praveen Kumar2
*1Krishna Teja Pharmacy College, Tirupati
2Associate professor, Krishna Teja Pharmacy College, Tirupati 

A B S T R A C T
Regulatory affairs professionals are key players in drug development to approve and through life cycle management of a drug. They are the primary communications link between the company and agencies such as FDA, MHRA, TGA etc., and they are responsible for keeping up the increasing scope and complexity of regulations both domestic and international. In the pharmaceutical industry, regulatory affairs professionals have expertise in the legal and regulatory environments, as well as in clinical research protocols. The present investigation helped to understanding the regulatory requirements relating to approval of applications for marketing the generic injectables in US, EU and Canada. In US and Canada, there is only one procedure however in Europe, there are four procedures viz Centralized Procedure, Decentralized Procedure, Mutual Recognition Procedure and National Procedure. And also explain the comparison of regulatory requirements between US, Europe and Canada with respect to Module 1, 2, 3, 4 and 5.

Keywords: Regulatory affairs, Pharmaceutical industry, Marketing, Generic injectable, Clinical research

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