Brasília – Anvisa announced the approval of the guiding document for the development of the future ICH M18 guideline, which will define international standards for the validation of analytical procedures. The document was endorsed during the latest meeting of the International Council for Harmonisation (ICH), where Anvisa serves as a regulatory member and co-leads the M18 Expert Working Group. According to the agency, the material establishes the foundational concepts and scope that will inform the drafting of the new harmonized guideline.

The initiative reinforces Brazil’s growing role in global regulatory harmonization and strengthens alignment with international best practices in pharmaceutical quality. Anvisa highlighted that its leadership in the M18 process supports industry predictability, enhances reliance opportunities and contributes to regulatory convergence across jurisdictions participating in the ICH framework.

Source: Anvisa