April 15, 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.

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

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