ABSTRACT

The drug registration process to acquire marketing authorizations for medicines in Latin American countries is highly country specific despite of various regional harmonization activities. Organizations must short out an effective worldwide strategy to get into the environment of pharmaceutical industry in Latin America so that complex and vivid requests from reviewer's can be solved without delaying local product launches. In this study four LATAM countries (Brazil, Chile, Bolivia and Honduras) were selected based on the increasing number of populations, prevalence of disease, increasing pharmaceutical imports and rise in economic growth. Study the Post Covid generic drug product registration guidelines and identify the change between Before Covid and Post Covid. There is regional "CTD-like" application for Brazil and Chile. For Bolivia and Honduras countries has its own requirements regarding to drug registration. The one major post covid change in the ANVISA (Brazil regulatory authority) the change is in GMP. ANVISA provides TEMPORARY GMP for the company after covid for the Medicine or health product usedin cases of serious health risk intended for the control, diagnosis, prevention or treatment to meet the health needs caused by the new Corona Virus Keywords: Generic Drug, Latin American regions, Regulatory requirements, Product Registration, Regulatory Body, Common Technical Document (CTD), Corona Virus
Publication date: 01/04/2024

https://ijbpas.com/pdf/2024/April/MS_IJBPAS_2024_7809.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.4.7809