Brasília – Brazil’s National Health Surveillance Agency (Anvisa) is inviting industry, academia and public institutions to submit contributions by 19 November 2025 to the regional consultation on the draft guideline ICH M4Q(R2), which updates the “Quality” section of the Common Technical Document (CTD). The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is revising Modules 2.3 and 3 to strengthen global convergence in regulatory standards.

The updated proposal expands applicability to both synthetic and biological products, reinforces concepts such as the Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQA), introduces the framework of Core Quality Information (CQI), and enhances lifecycle management provisions. Anvisa encourages broad participation to ensure alignment with international best practices and to support the competitiveness of Brazil’s pharmaceutical sector.

Source: Anvisa