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

[ Vol. 7 , Issue. 2 ]

Author(s):

Mohit, Aakash Deep*, Gaurav Khurana, Jagdeep Kumar and Akshay Monga   Pages 117 - 125 ( 9 )

Abstract:


The product registration in the rest of the World is a challenging task because the regions under it are not harmonized. CIS and Latin American 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, LATAM region, administrative documents.

Affiliation:

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

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