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Research Journal of Pharmacy and Technology
Year : 2017, Volume : 10, Issue : 1
First page : ( 286) Last page : ( 292)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2017.00059.2

Regulatory Filing In Us and Eu: A Comparative View

Raji Kamalraj1, Aanandhi Vijey M2,*

1Research Scholar, Department of Pharmaceutical Chemistry, School of Pharmaceutical Sciences, Vels University (VISTAS), Chennai, Tamil Nadu, India

2Department of Pharmaceutical Chemistry, School of Pharmaceutical Sciences, Vels University (VISTAS), Chennai, Tamil Nadu, India

*Corresponding Author E-mail: hodpchemistry@velsuniv.ac.in

Online published on 29 April, 2017.

Abstract

Regulatory Affairs in pharmaceutical industry is dealing with all aspects of government affairs and to fulfill the requirements of Pharma regulatory agency of the concerned nations and deals with obtaining the approval from license, development of a pharmaceutical product to manufacturing, drug approval process and registration of pharmaceutical products for sale and distribution in different regulated markets and for post marketing studies. The pharmaceutical companies must adhere to the legislations that require drugs to be developed, tested, trialed, and manufactured in accordance to the guidelines so that they are safe and patient's well-being is protected. This topic aims at reviewing about the basics of drug regulatory filing in pharmaceutical industry and to gain knowledge about the different aspects of introducing drug product(s) into USFDA/Europe regulated market.

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Keywords

Regulatory Affairs, Filing and USFDA/Europe.

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