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

(E-pub Ahead of Print)

Author(s): Mohit, Aakash Deep*, Gaurav Khurana, Jagdeep Kumar, Akshay Monga.

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

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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

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Article Details

(E-pub Ahead of Print)
DOI: 10.2174/2213476X06666191023093840

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