Generic Drug Makers Face Regulatory Hurdles Navigating Brazil’s ANVISA and Mexico’s Cofepris in Latin America

Generic drug manufacturers face a complex regulatory landscape in Latin America as they seek to capitalize on the rising global demand for affordable medicines, according to a recent analysis. The report highlights the unique regulatory hurdles in countries like Brazil and Mexico that companies must overcome to succeed in this lucrative market. Specifically, the analysis points to the intricacies of Brazil’s ANVISA and the potential pitfalls of Mexico’s Cofepris, the FDA-equivalent, as examples of the challenges confronting generic drug makers. Companies must navigate these country-specific regulations to gain market access in Latin America. The full analysis can be found at https://www.drugpatentwatch.com/blog/regulatory-challenges-in-the-latin-american-generic-drug-market/.

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Date: April 15, 2025

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Author

Mark Chiang

紐約 NYU Computer Science 碩士 紐澤西 UMDNJ Biomedical Informatics 博士 中研院博士後 台灣大學博士後