ANVISA – New Regulatory Framework for Medical Cannabis

The 1st Public Meeting of the Collegiate Board (DICOL) of 2026, held on January 28, was consolidated

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ANVISA – Highlights from the 3rd Dicol Meeting 2026

The 3rd Public Meeting of the Dicol in 2026 reaffirmed ANVISA’s trajectory towards a more tran

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The Digital Modernization of CADIFA and its Evolution in the Brazilian Regulatory Landscape

Within the scope of the recent digital transformation initiatives led by the Brazilian Health Regula

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INFARMED – Mandatory submission of national pharmacovigilance contact details via the SMUH-ALTER Portal

On 30 October 2025, INFARMED published the Informative Circular No. 125/CD/550.20.001, introducing

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Vita participates in a workshop on the advances and challenges of Advanced Therapies in Brazil

Vita attended the workshop “The Journey of Advanced Therapies in Brazil – Advances, Challenges,

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ANVISA – Atualização da RDC 948/2024

A RDC 948/2024, publicada em dezembro de 2025 como novo marco regulatório para registro de medicame

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ICH M4Q(R2): draft revision open for public consultation

As part of the work initiated in 2021 by the International Council Harmonization (ICH), the revision

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A New Era in Medicines Regulation in the European Union (EU): From the artificial intelligence (AI) Strategy to the First AI Observatory Report

In May 2025, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA – th

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ANVISA – Cadifa Panel Launches!

Anvisa has just launched two extremely useful panels for monitoring the process of Letter of Suitabi

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ANVISA – Publication of the regulation for admissibility of analysis carried out by a Foreign Regulatory Authority (Reliance) in Brazil

In August 2022, ANVISA published the Resolution – RDC No. 741, of August 10, 2022, which provides

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EMA – ICH opens public consultation for international harmonization of real-world evidence terminology

The European Medicines Agency has published for public consultation an ICH Reflection Paper on “Pr

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ANVISA – List of Active Substances for Periodic Benefit-Risk Evaluation Reports (updated on December 20th, 2021)

On December 13th, 2021, ANVISA published the list of Periodic Benefit-Risk Assessment Reports (RPBR)

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