A meeting took place on 24 March 2026 that was to discuss the evolving regulatory landscape for Advanced Therapy Medicinal Products (Médicaments de thérapie innovante MTI). The National Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé ANSM) convened the Interface Committee with medicinal product industry representatives (Comité d’interface avec les représentants des industries du médicament CIDIM) to address technical barriers to market entry.
On the agenda was the transition from the hospital exemption (exception hospitalière EH) to formal marketing authorisations. This item addressed the challenge of standardising manufacturing data for custom-made therapies as they move from academic settings to industrial production. The state aims to ensure that these treatments meet rigorous quality thresholds before they reach wider patient populations.
The committee also scheduled discussions on the alignment of national procedures with the European Union Joint Clinical Assessment framework. This measure intended to address the administrative burden caused by overlapping clinical data requirements at the national and European levels. Ensuring that technical dossiers satisfy both sets of criteria remains a priority for the agency to avoid delays in patient access.
These exchanges indicate a shift toward a more centralised and data-heavy evaluation process for innovative therapies. Closer alignment with European Union timelines will determine the speed of national access decisions throughout the remainder of 2026. Success will depend on the ability of manufacturers to ensure that manufacturing protocols are ready for industrial scrutiny at the point of initial clinical submission to avoid regulatory delays.
Source: Agence nationale de sécurité du médicament et des produits de santé
Link: Comité d’interface avec les représentants des industries du médicament - Médicaments de thérapie innovante (Interface Committee with medicinal product industry representatives – Advanced Therapy Medicinal Products)
Date: 24 March 2026
