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.
Basak S. Pharmaceutical market and regulatory contents for export of pharmaceutical products to Latin American Countries. IOSR J Pharm 2018; 8(4): 60-72.
Sravani M, Kusuma SM, Prabhahar AE, Nadendla RR. Registration of generic drugs in central America and Mexico. Int J Pharm Chem Res 2017; 3(3): 635-50.
Sri SB, Prabahar AE. current scenario of generic drug regulation and registration process in Latin America Countries. Int J Pharm Chem Res 2017; 3(4): 857-78.
Praneetha K, Prakash B, Umasankar K, Alagusundaram M, Jayachandra RP. Study on the regulatory requirements for registration of pharmaceuticals for human use in common wealth of independent states. J Sci 2014; 4(8): 486-504.
Rights & PermissionsPrintExport