3 de setembro de 2019

ANVISA NEWS: Public Consultation on Advanced Therapy Products

From: www.anvisa.gov.br

Are you aware of the Brazilian Public Consultation n. 706?

This is an important public consultation, which deals with a proposal for a new regulation for registration of advanced therapy products in Brazil.

The draft released by the Regulatory Authority (ANVISA), aims to determine minimum requirements for the registration of these products, (and waiver conditions in specific cases), as also to set deadlines for analysis and prioritization, to ensure its quality, safety, and effectiveness.

Anvisa already has a Sectoral Dialogue scheduled to October 8, in Brasilia, to present and discuss the draft, just as it was done last year when the draft (public consultation n. 416) for applicable criteria for clinical studies with advanced therapy products was released (already in force as the RDC n. 260/2018). 

Sectoral Dialogues are meetings - face to face or virtual - generally aimed at specific audiences to validate information and search demands. 

In practice, these are informal meetings that can be held with different segments in the regulatory process under consideration. 

How to participate?

The public consultation was officially published in the Federal Official Gazette (D.O.U.) last August, 28 and will be receiving contributions until October 19. 

It is available (only in Portuguese) on the Anvisa website, and suggestions should be submitted by completing a specific form.

All contributions received are considered public and will be available in the "result" menu of the electronic form, including during the consultation process.

After October 19, Anvisa will analyze the contributions and, if appropriate, promote discussions with those who have expressed interest in the matter, in order to provide further input for technical discussions and deliberation of the new regulation. 

Important: International contributions may also be sent in physical media and addressed to Anvisa / International Affairs Office (AINTE), at the address "SIA, Excerpt 5, Special Area 57, Brasília - DF, CEP 71.205-050, Brazil".