IN 289/2024 outlines the criteria for the optimized analysis procedure, which relies on assessments by Equivalent Foreign Regulatory Authorities (AREE) for the registration and post-registration of medicines, biological products, vaccines, and Active Pharmaceutical Ingredient Dossier (CADIFA).
With this optimized process, 28 CADIFAs have already been approved, with an almost 90% reduction in approval time, taking an average of just 20 days and no deficiency letters.
The Normative Instruction brings more celerity on Anvisa’s approval of registration processes of medicines and APIs in Brazil, keeping the quality, safety and efficacy of medicines.
The document is now also available in English version to enhance access for international stakeholders.
