BRAZIL

On February 16, the National Health Surveillance Agency (ANVISA in Portuguese) published the opening of a public consultation for the revision of the Mercosur Technical Regulation on Clinical Trials with Drugs, Biological Products and Medical Devices. You can access the text by clicking here. 

The deadline to send criticisms and suggestions on the project is from 23/02/2022 to 25/04/2022. These contributions can be sent through an electronic form that will be available on ANVISA’s website when the consultation is enabled on February 23rd. 

The resolution, which is submitted for public consultation, was drafted to update the regulatory framework for the harmonization of clinical trials applicable in MERCOSUR member states, in light of internationally accepted guidelines and reference documents on human research.

It should be noted that this document understands by clinical trial any research conducted with human subjects to verify the safety and/or efficacy of drugs and medical products. Its intention includes discovering or verifying the clinical, pharmacological and or any other pharmacodynamic and/or pharmacokinetic effects of the investigational products, and/or identifying any adverse reactions to the investigational products to study their effect, absorption, distribution, and metabolism.