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

15 de May de 2026

CONAR updates Influencers Guide in line with the new requirements for transparency and protection in the digital environment

The National Council for Advertising Self-Regulation (“CONAR”) released, last Monday (11), the new edition of the Guide to Marketing and Advertising by … CONAR updates Influencers Guide in line with the new requirements for transparency and protection in the digital environment

Ler notícia

11 de May de 2026

Digital ECA: Signs of Practical Enforcement of the New Regulatory Framework

The Digital Statute of the Child and Adolescent (Law No. 15,211/2025 – “Digital ECA”) came into effect in March 2026 and is … Digital ECA: Signs of Practical Enforcement of the New Regulatory Framework

Ler notícia

27 de March de 2026

New Structure of the ANPD and Impacts Brought by the Digital Child and Adolescent Statute

Among the most recent publications related to the Brazilian Data Protection Agency (“ANPD”), the release of Decree No. 12.881/2026 stands out. The Decree approves … New Structure of the ANPD and Impacts Brought by the Digital Child and Adolescent Statute

  • Kasznar Leonardos
    • Ler notícia

    Check out our Social Responsability and Sustainability projects

    Meet our complete team