Agence Nationale de Sécurité du Médicament (ANSM) is Franceís national regulatory authority overseeing medicines and clinical trials.
ANSM evaluates trial applications, monitors safety reporting, and enforces compliance with EU regulations. Sponsors must submit dossiers and safety updates according to ANSM requirements. Regulatory expectations influence study design and reporting practices. Coordination with ANSM is critical for successful multinational research operations.