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

25 de August de 2026

Brazilian Patent and Trademark Office and Uruguay’s DNPI Launch Collaborative Patent Application Examination Project

On August 25, 2026, the Brazilian Patent and Trademark Office (INPI) announced the launch of a Collaborative Patent Application Examination Project in … Brazilian Patent and Trademark Office and Uruguay’s DNPI Launch Collaborative Patent Application Examination Project

Ler notícia

19 de August de 2026

Brazilian PTO Publishes 2027–2036 Strategic Plan: What It Means for Users of Brazil’s IP System

Brazil’s National Institute of Industrial Property (INPI) released its new Strategic Plan for 2027–2036 on August 14, 2026. The plan launches a … Brazilian PTO Publishes 2027–2036 Strategic Plan: What It Means for Users of Brazil’s IP System

Ler notícia

14 de August de 2026

INPI and INDECOPI Launch Collaborative Patent Examination Project Focusing on Pharmaceuticals and Biotechnology

On August 11, 2026, the Brazilian Patent and Trademark Office (INPI) announced the launch of the Collaborative Patent Application Examination Project, developed … INPI and INDECOPI Launch Collaborative Patent Examination Project Focusing on Pharmaceuticals and Biotechnology

Ler notícia

Check out our Social Responsability and Sustainability projects

Meet our complete team