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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 [...]
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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 [...]
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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 [...]
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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 [...]
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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 [...]
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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 [...]
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ANVISA – Guideline on Remote Inspections
On November 25th, 2021, Anvisa published Guideline No. 54/2021 (version 1) on Remote [...]
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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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ANVISA – The addition to the application of origin should be submitted by electronic system – Sistema Solicita
In order to improve the link between applications for addition to their respective applications [...]
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ANVISA – Process Optimization for importing Cannabis-based products by individuals in Brazil – updated on November 29th
In October 2021, some important rules were published for the process of importing [...]
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ANVISA – Agency accepted in international inspection program
The Brazilian Regulatory Agency (Agência Nacional de Vigilância Sanitária – ANVISA) was [...]
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Whitepaper – Differences between CADIFA (Letter of Suitability of the Active Pharmaceutical Ingredient) – ANVISA and CEP (Certificate of Suitability) – EDQM
In April 2021, the New Regulatory Framework for APIs in Brazil completed one year since its [...]
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