Addressing the challenges of implementing the common technical document in Brazil

By Jane Cristina da Cruz Barcelos, Juliana Schwarz Rocha, Vanessa Rodrigues Marques, Beatriz Gama Pompeu, Ana Paula Iacuzio Avella and Gustavo Mendes Lima Santos2025-01-10T08:52:00

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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