Abstract

“CURRENT SCENARIO OF GENERIC DRUG REGULATION AND REGISTRATION PROCESS IN ARGENTINA AND BRAZIL -(LATIN AMERICA) LATAM COUNTRIES”

*Ramya Sree, A. E. Prabahar and N. Rama Rao

ABSTRACT

The study highlighted the “CURRENT SCENARIO OF GENERIC DRUG REGULATION AND REGISTRATION PROCESS IN ARGENTINA AND BRAZIL -(Latin America)LATAM COUNTRIES” and also a brief description about the License Applications and its requirements to fill and submit to the Regulatory Authorities. The requirements to submit to market a Generic drug registration in LATAM are country specific. It was observed that the LATAM region does not have an integrated or consistent procedure for drug registration. Some countries are having tough and stringent rules and regulation, that form obstacles in the path of Generic drug approval process, and some have lax regulations that make plenty of drug registration without a thorough looks over the safety and efficacy, simply bio-equivalency. There are critical differences between countries in the region. Most countries require additional documentation that is not part of Modules 2–5 of the CTD, some of which might also be challenging to obtain. In order to help alleviate some of those difficulties and promote trade between Latin American countries, several regulatory bodies have entered into interchange agreements. As emerging markets capture a greater share of the global pharmaceutical market, LATAM countries are altering and adapting their regulations to compete with the quality expectations of highly regulated markets like the EU and US.

Keywords: Generic, LATAM, ARGENTINA, BRAZIL, US, CTD, EU.