ANVISA updates the Active Ingredient Registration Panel (Painel de Princípios Ativos em Registro): expanded data, greater depth for regulatory intelligence

In its original format, the panel displayed three variables per entry: active ingredient, regulatory category, and number of pending processes. The updated version introduces two additional dimensions: pharmaceutical form and concentration. The interface has also been redesigned for improved usability.

The practical implications for companies operating in the Brazilian market are substantial. The panel now enables:

  1. more granular identification of submitted formulations — distinguishing, for example, between different dosage forms or strength ranges of the same active ingredient;
  2. deeper assessment of competitive density by product profile, rather than by active ingredient alone;
  3. more informed decisions on prioritization requests, based on the actual volume and profile of pending submissions for a given molecule and form; and
  4. validation or recalibration of submission strategies for products in prospecting or development.

The panel covers all registration categories: new medicines, generics, similars, specific medicines, herbal medicines, biologics, biosimilars, radiopharmaceuticals, and advanced therapy products. Clone medicines (RDC No. 954/2024) are not included.

Those classified as Innovators are grouped in the New Medicines category.

No official notice has been published by ANVISA regarding this update. The changes are accessible directly through the panel.

Access the panel


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