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

17 de December de 2025

Fast-track Examination Requests, including PPH, will be temporarily suspended in Brazil for Telecommunication Cases

By means of Ordinance 17/2025, published on December 16, 2025, the BPTO has announced that fast-track examination routes, including the Patent Prosecution … Fast-track Examination Requests, including PPH, will be temporarily suspended in Brazil for Telecommunication Cases

9 de December de 2025

Fake Software Resellers: A Growing Risk for Users and a New Front in IP Enforcement

For years, the most common form of software piracy involved downloading cracked or unauthorized versions from websites offering them for free. Although … Fake Software Resellers: A Growing Risk for Users and a New Front in IP Enforcement

Kasznar Leonardos

25 de November de 2025

Significant Win for Kasznar Leonardos as Appellate Court Raises Compensation in Software Infringement Case

Kasznar Leonardos is pleased to announce an important victory before the São Paulo Court of Appeals in a software license compliance action … Significant Win for Kasznar Leonardos as Appellate Court Raises Compensation in Software Infringement Case