Brazil Advances Healthcare Regulation with Public Input on Medicinal Validation

Brazil Advances Healthcare Regulation with Public Input on Medicinal Validation

Brazil, through its Health Regulatory Agency (ANVISA), has notified the World Trade Organization (WTO) about its draft resolution 1245, regarding the validation of bioanalytical methods used in the regulation of industrialized medicines for human use. The draft resolution sets out detailed requirements for the description of bioanalytical methods that quantify drugs in biological matrices, aligning with international standards established by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Stakeholders are called to provide feedback by May 15, 2024. The resolution is a crucial step towards updating Brazil's regulations to incorporate advanced tests for chromatographic and Ligand Binding Assay (LBA) bioanalytical methods. This move, aimed at ensuring the protection of human health and safety, highlights Brazil's commitment to enhancing regulatory standards in line with global best practices.

The draft document is available for download in Portuguese, and comments can be submitted through the provided online form. The draft resolution and comment form reflect ANVISA's dedication to transparency and international collaboration in the regulatory process.

Title of document
Draft resolution 1245, 20 March 2024

Notification: G/TBT/N/BRA/1528

Documents

• 24_02293_00_x.pdf
• CONSULTA+P%C3%9ABLICA+N%C2%BA+1245+DIRE2.pdf
• index.php