Brazil: Consultation Open on Criteria for Priority Review

The Public Consultation - CP No. 26 - on proposed new criteria for establishing the priority review for registration of medicines opened on April 20 and comments may be submitted within 30 days.

The proposal would grant priority review according to a points system to products that reach at least 10 points.

The application for prioritization would have to be made electronically and ANVISA would have 75 days to decide on petitions for priority registration, 90 days for post-registration priority, and 45 days for prior consent for clinical research.

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ANVISA - Consulta Pública nº 26, de 11 de abril de 2012