The ANSM (the French Medicines Agency) has launched a new platform to support makers of innovative health products.
ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) is the regulatory body for health technologies in France. The Innovation and Orientation Window on Simplified Procedures will enable dialogue and advice between the regulator and “those involved in innovation in the field of drugs and medical devices”.
“Project leaders can contact us in a few clicks for scientific advice or regulatory support, and also ask us for pre-submission meetings and presentations of development portfolios.
“By structuring and simplifying the various activities of the Agency, the Guichet makes it possible to better meet the expectations of the various carriers of innovations (public and private) in terms of support, while respecting ethical obligations.”
It is hoped the platform will lead to earlier, better understanding of the safety (and other) requirements for new innovations.