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Comparison of Basic Regulatory Requirements for Generic Drug Products Registration in CIS and Latin American Countries

Author(s):

Mohit, Aakash Deep*, Gaurav Khurana, Jagdeep Kumar and Akshay Monga   Pages 1 - 9 ( 9 )

Abstract:


The product registration in Rest of the World is a challenging task because the regions under it are not harmonized. CIS and Latin America regions come under semi-regulated market. These regions have somewhat harmonized their regulatory organization. The significance of an emerging market is increasing globally. It is important for pharmaceutical companies to be up-to-date with the latest regulatory development. Both the regions follow their regional checklist for Drug Product Registration. Latin America includes a group of countries like Brazil, Guatemala and Peru etc, Whereas CIS includes Russia, Ukraine, Uzbekistan, Armenia and Tajikistan etc. Keywords: Generic Drug, Latin American regions, Regulatory requirements, Product Registration.

Keywords:

Generic Drug, Latin American regions, Regulatory requirements, Product Registration

Affiliation:

Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, India Rhydburg Pharmaceuticals Ltd., New Delhi-110009, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, India Rhydburg Pharmaceuticals Ltd., New Delhi-110009, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, India Rhydburg Pharmaceuticals Ltd., New Delhi-110009, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, India Rhydburg Pharmaceuticals Ltd., New Delhi-110009, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021, India Rhydburg Pharmaceuticals Ltd., New Delhi-110009



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