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Law No. 15,471/2026 – Ensceis: Brazil’s new legal framework for the Health Economic-Industrial Complex and its implications for the pharmaceutical sector
On July 20, 2026, Law No. 15,471/2026 was enacted, establishing the National Health Strategy for B
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In the development and delivery of regulatory solutions, technical excellence is inseparable from th
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EFPIA | WifOR study: every €1 invested in innovative medicines returns €5.67 to Europe
In June 2026, the European Federation of Pharmaceutical Industries and Associations (EFPIA) publishe
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ANVISA – IN No. 451/2026
On June 15, 2026, Normative Instruction (IN) No. 451/2026 was published in the Diário Oficial da Un
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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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