Brasília – Anvisa has updated the rules that determine which medicines and related applications qualify for priority review, revising criteria that critics considered outdated and no longer effective at accelerating regulatory evaluations. The changes, discussed in a public consultation process, aim to refine the priority classification system used in the analysis of marketing authorization, post-registration amendments and clinical research, with the goal of improving regulatory efficiency and alignment with current public health and industrial priorities.
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According to the agency, the revision seeks to address technical and procedural issues that had limited the impact of priority categorization on review times, though stakeholders note the need for ongoing monitoring of implementation. The updated rules could influence how innovative therapies, domestically developed products and strategically important medicines are handled within the review queue, potentially affecting access timelines in Brazil’s health market.
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Source: JOTA