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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 August

Established under Law No. 13,098/2015, Brazil’s National Health Surveillance Day is observed o

On July 20, 2026, ANVISA published the 1st edition of the Questions & Answers (Q&A) document

In its original format, the panel displayed three variables per entry: active ingredient, regulatory

On July 20, 2026, Law No. 15,471/2026 was enacted, establishing the National Health Strategy for B

In the development and delivery of regulatory solutions, technical excellence is inseparable from th

In June 2026, the European Federation of Pharmaceutical Industries and Associations (EFPIA) publishe

On June 15, 2026, Normative Instruction (IN) No. 451/2026 was published in the Diário Oficial da Un

On 17 June 2026, Decree-Law No. 118/2026 was published in Portugal, establishing a new framework for

ANVISA published, on June 29, 2026, Informative Note No. 1/2026/SEI/GGBIO/DIRE2, updating guidance

In force since June 26, 2026, the new wording of Art. 18 of Law No. 6,360/1976 introduces a relevant

The validation of analytical procedures is an integral part of the registration and post-registratio