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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Whitepaper: Medicinal Cannabis Products – Regulatory differences between Brazilian and Mexican Legislations

We have published our new Whitepaper that describes the main differences between Mexican and [...]

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ANVISA – Update of the Guideline 20/2019 on topical and transdermal products

ANVISA published the second version of Guideline 20/2019, which provides guidance on quality [...]

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Whitepaper: Diffferences between CTD Brazil and UE: a look at CMC requirements

Our daily lives at Vita are full of discussions about technical and regulatory differences in [...]

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ANVISA – Public Consultation for Revision of RDC 47/2009, which establishes the rules for drug package leaflet

On December 2020, ANVISA published the Public Consultation for Revision of DRC Nº 47 of [...]

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