The National Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM) issued a decision on 23 March 2026 modifying the National Directory of Generic Groups (Répertoire des groupes génériques, RGG). This update – which constitutes a significant shift in regulatory communication – establishes the agency website as the sole legal authority for group notifications. This change replaces the requirement for publication in the Journal officiel de la République française (JO) and ensures that substitution rights take effect the moment the digital entry is live.
The decision has dual implications for market access and expenditure control. First, it eliminates the historical time lag between a regulatory decision and its enforcement. Pharmacists must not initiate substitution within the newly created groups until the digital publication occurs – but they may start immediately thereafter. This streamlined flow allows the Economic Committee for Health Products (Comité économique des produits de santé, CEPS) to apply the Flat-Rate Reimbursement Price (Tarif Forfaitaire de Responsabilité, TFR) without waiting for government printing cycles.
Second, the update expands the scope of reference pricing by adding high-volume molecules to the RGG. These new categories include several oral antidiabetics and anticoagulants – specifically sitagliptin and rivaroxaban – which were previously outside the genericised reimbursement framework. By bringing these therapies into the directory, the regulator enables the immediate application of TFR levels. These data show that such price caps effectively align originator costs with the lowest-priced generic in the group.
The measure applies to all entries posted from 23 March 2026. This administrative acceleration will likely increase the speed of generic erosion for off-patent brands. Manufacturers of established products must now anticipate a more compressed timeline between patent expiry and the imposition of reference pricing. Success in managing these transitions will require real-time monitoring of the ANSM digital portal to mitigate sudden shifts in reimbursement and market uptake.
Source: Agence nationale de sécurité du médicament et des produits de santé
Link: Décision du 23/03/2026 : modification au répertoire des groupes génériques mentionné à l'article R. 5121-5 du code de la santé publique (Decision of 23 March 2026: Modification to the directory of generic groups mentioned in Article R. 5121-5 of the Public Health Code)
Date: 23 March 2026
