The Agence nationale de sécurité du médicament et des produits de santé (ANSM) updated its support framework for healthcare innovation on 19 December 2025. The policy paper, titled Guichet Innovation et Orientation (GIO)(Innovation and Orientation Desk), details a dedicated service designed to provide scientific, technical, and regulatory assistance to researchers and small-to-medium enterprises.
Christelle Ratignier-Carboneil, Directrice générale of the ANSM, oversaw the release of revised templates for briefing books – essential documents used to provide the scientific evidence required for experimental medicines and medical devices. Previously, the support process relied on more informal interactions. The updated measures now mandate a standardised submission path via the demarches-simplifiees.fr platform, ensuring that project developers can identify potential scientific or regulatory issues early in the development cycle.
The desk provides various levels of support, including protocol assistance and pre-submission meetings. These sessions allow developers to address up to six specific scientific questions regarding quality, pre-clinical data, or clinical development within a 90-minute consultation. This guidance is particularly critical for products targeting unmet medical needs or rare diseases, where standard clinical trial designs may not be feasible.
By providing early scientific advice, the agency ensures that the data being generated are robust enough to support future requests for accès précoce (early access). This proactive approach aims to bridge the gap between initial research and clinical application, ensuring that innovative treatments meet safety and quality standards before reaching patients.
The implementation of these standardised models will streamline the evaluation of breakthrough therapies. Developers are now expected to provide more precise scientific justifications for their development programmes, which will lead to higher-quality submissions and more predictable regulatory outcomes for novel health products.
Source: Agence nationale de sécurité du médicament et des produits de santé (ANSM)
Link: Innovation and Orientation Desk
Date: 19 December 2025