All Brazil articles
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JournalAddressing the challenges of implementing the common technical document in Brazil
The common technical document (CTD) is the standard format for regulatory dossiers. It was developed in early 2000 for use in Europe, the United States (US) and Japan, and is currently accepted in several other regions such as Australia, Canada, India, South Africa, Switzerland and, since August 2019, Brazil, with the publication of Guide N°24/2019 from the Brazilian Health Regulatory Agency (Anvisa).
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JournalThe transition period of the new API framework in Brazil is coming to an end
The new active pharmaceutical ingredients regulatory framework in Brazil begins August 2023
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InterviewBuilding best regulatory practices in Brazil
Gustavo Mendes Lima Santos, General Manager of Medicines and Biological Products at ANVISA, explains how the agency has aligned with best practices of others across the world, and discusses important updates to legislation in Brazil.