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Portugal updates SiNATS: what changes with Decree-Law No. 118/2026?
On 17 June 2026, Decree-Law No. 118/2026 was published in Portugal, establishing a new framework for
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ANVISA – Informative Note No. 1/2026/GGBIO/DIRE2: updated guidance on the evaluation of comparative pharmacokinetic studies for biosimilars
ANVISA published, on June 29, 2026, Informative Note No. 1/2026/SEI/GGBIO/DIRE2, updating guidance
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Law No. 15,440/2026: proof of registration in the country of origin is no longer a legal requirement for registering medicines in Brazil.
In force since June 29, 2026, the new wording of Art. 18 of Law No. 6,360/1976 introduces a relevant
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ANVISA – Proposed revision of RDC No. 166/2017: international harmonization of analytical method validation parameters.
The validation of analytical procedures is an integral part of the registration and post-registratio
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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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