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, Akshay Monga

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs

Volume 7 , Issue 2 , 2020

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Graphical Abstract:


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.

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Article Details

VOLUME: 7
ISSUE: 2
Year: 2020
Page: [117 - 125]
Pages: 9
DOI: 10.2174/2213476X06666191023093840

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