Our Policies
News

Newsletter

15 de April de 2021

ANVISA opens a Public Consultation to improve the reliance on foreign regulatory authorities’ opinions

ANVISA’s Board of Directors opened a Public Consultation (“PC 1,039/2021”), available to contributions between 04/15/2021 and 06/15/2021, to discuss a proposed regulation to establish criteria for ANVISA to rely on the analysis carried out by equivalent foreign regulatory authorities for the purposes of marketing approval of products, optimizing the current procedures.
The optimized analysis consists of a procedure that uses a regulatory document issued by an equivalent foreign regulatory authority to streamline the efficiency of Anvisa’s assessment, avoiding duplication of efforts.
The proposal establishes that the equivalent foreign regulatory authorities must have the same standard of health protection and must adopt international standards and guidelines similar to those adopted by ANVISA, including good regulatory practices. 
In addition, authorities that are part of a cooperation program or association integrated by ANVISA may be considered equivalent depending on the category of the product or process. In this case, the foreign regulatory authority would be considered equivalent by a decision to be rendered by ANVISA’s Board of Directors and the updated list of the equivalent authorities would be available on ANVISA's website.  
The main goals of the proposal are:
 
(i) increase product availability through predictability and legal certainty to companies,
(ii) savings in time and financial resources and,
(iii) more strategic use of ANVISA’s resources.
Last but not least, the proposal also presents provisions to stress ANVISA’s autonomy despite the reliance within the optimized procedure. 
For more information, please do not hesitate to contact our team via email: regulatorio@kasznarleonardos.com. 
 
Back

Last related news

20 de October de 2025

Brazil enacts the ECA Digital: a landmark law for children’s rights in the Digital Age

Last month, Brazil took a major step toward regulating the digital environment for children and adolescents with the enactment of the ECA … Brazil enacts the ECA Digital: a landmark law for children’s rights in the Digital Age

Ler notícia

17 de October de 2025

New Rules for Clinical Research: Federal Government Bets on Regulation to Boost Innovation and Investment

Brazil, despite being among the top 20 countries in terms of the number of clinical trials, contributes less than 2% of global … New Rules for Clinical Research: Federal Government Bets on Regulation to Boost Innovation and Investment

  • Kasznar Leonardos
    • Ler notícia

    13 de October de 2025

    2025 Nobel Prize in Economics: innovation as an engine of transformation

    The 2025 Nobel Prize in Economic Sciences recognized Joel Mokyr, Philippe Aghion, and Peter Howitt for their theoretical contributions on how innovation … 2025 Nobel Prize in Economics: innovation as an engine of transformation

    Ler notícia

    Check out our Social Responsability and Sustainability projects

    Meet our complete team