Active Pharmaceutical Ingredients
In 2020, Anvisa published a new framework for Active Pharmaceutical ingredients (APIs). Since then, Anvisa has issued the Letter of Suitability of the Active Pharmaceutical Ingredient (CADIFA, in Portuguese) for APIs used in the manufacture of new, innovative, generic, and similar medicinal products, in accordance with RDC 359/2020.
Supporting Materials
Normative
- RDC 359/2020 - This Resolution institutes the Active Pharmaceutical Ingredient Dossier (DIFA) and the Letter of Suitability of the Active Pharmaceutical Ingredient (CADIFA)
- IN 289/2024 - Establishes the optimized analysis procedure where reviews conducted by Equivalent Foreign Regulatory Authority (AREE) are used to analyze the letter of suitability of the active pharmaceutical ingredient (CADIFA)
Guidance
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