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

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

Volume: 7 Issue: 2

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

Affiliation:

• Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani 127021,India

Keywords: Generic drug, latin American regions, regulatory requirements, product registration, LATAM region, administrative documents.

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.

Cite this article as:

Mohit , Deep Aakash *, Khurana Gaurav , Kumar Jagdeep and Monga Akshay, Comparison of Basic Regulatory Requirements for Generic Drug Products Registration in CIS and Latin American Countries, Applied Clinical Research, Clinical Trials and Regulatory Affairs 2020; 7 (2) . https://dx.doi.org/10.2174/2213476X06666191023093840