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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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ANVISA – Deadline extension for the implementation of packaging process online control and 100% integrity test
After some deliberations between the regulated sector and the regulatory authority, on December 1st,
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ANVISA – Guideline on Remote Inspections
On November 25th, 2021, Anvisa published Guideline No. 54/2021 (version 1) on Remote Inspections. Du
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EDQM – Notification to CEP holders: Implementation of the European Pharmacopoeia Supplement 10.7
In October 2021, the EDQM (European Directorate for the Quality of Medicines and Healthcare) publish
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ANVISA – Publication of new regulation to expand clinical trials with medicinal products in Brazil
On November 3rd, 2021, ANVISA published the Resolution of the Collegiate Board of Directors –
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