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How To Winning the ANVISA Drug Registration Race
This podcast, Episode [32], introduced with the "DDReg Knowledge capsule" greeting, provides a deep dive into the complexities of pharmaceutical registration in Brazil. It explores the central role of ANVISA (National Health Surveillance Agency) and the specific regulatory pathways designed to accelerate market entry, such as Priority Review and the Reliance and Expedited Pathway. The discussion covers critical technical requirements, including the use of the Common Technical Document (CTD) format for dossiers and the shift toward completely paperless filing via Datavisa. Furthermore, the…
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