Wednesday , 25 November 2020

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

Jaldu Praveen*, K Sreejan1, 2P. Jaya Chandra Reddy
*1Krishna Teja Pharmacy College, Renigunta Road, Tirupathi.
*2Principal Krishna Teja Pharmacy College, Renigunta Road, Tirupathi.

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. The aim of present research work Understand the requirements of the Regulatory Authorities governing the drugs in USA, European Union and Canada to register generic injectables in these regions. This study helped in 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.  A comparison of regulatory requirements between US, Europe and Canada with respect to Module 1, 2, 3, 4 and 5are also discussed in the study.
Keywords: Regulatory affairs, Injectables, FDA, Drug development

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