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RDC 997/2025: Understanding the Resolution’s Impact and Developments in ANVISA’s Application Review
In November 2025, ANVISA published Resolution RDC No. 997, of November 7, 2025, which governs [...]
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ANVISA approves pilot project for optimized quality review based on the REQ
On September 2, 2026, ANVISA’s Board of Directors approved, during its 16th Public [...]
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Vita Participates: ANVISA Seminar on the New Regulatory Framework for Herbal Medicines
On August 28, Vita attended the seminar hosted by ANVISA in Brasília on the new regulatory [...]
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ANVISA publishes IN 467/2026: List of qualified impurities and their respective limits in accordance with RDC No. 964, from February 20, 2025.
On August 26, 2026, ANVISA published Normative Instruction (IN) No. 467/2026, amending IN No. [...]
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ANVISA updates Q&A on relative bioavailability/bioequivalence studies (Resolution RDC No. 742/2022)
On August 24, 2026, ANVISA published the 6th edition of its Questions and Answers document on [...]
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ANVISA opens to contributions for the review of the regulatory framework for biological products
On August 20, 2026, Brazil’s Health Regulatory Agency (ANVISA) opened a technical [...]
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ANVISA releases priority queues for GMP certification applications
Brazil’s Health Regulatory Agency (ANVISA) has begun publishing queues of Good [...]
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ANVISA – new application form for GMP certification for advanced therapy medicinal products
On August 14, 2026, Brazil’s Health Regulatory Agency (ANVISA) released the new Good [...]
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ANVISA updates guidance on Periodic Benefit-Risk Evaluation Reports (PBRER)
A new schedule for preparing Periodic Benefit-Risk Evaluation Reports (PBRER) took effect on [...]
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Health surveillance: the network that follows every stage of Brazilians’ day
Established under Law No. 13,098/2015, Brazil’s National Health Surveillance Day is [...]
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ANVISA – Questions & Answers on the Sanitary Authorization of Cannabis Products: RDC No. 1,015/2026
On July 20, 2026, ANVISA published the 1st edition of the Questions & Answers (Q&A) [...]
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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, [...]
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