Italian AIFA widens simplified medicine-authorisation route

Italy has widened the simplified route used for certain national, mutual-recognition and decentralised marketing-authorisation applications. The procedural change allows more applications to receive an automatically determined supply status and classification without referral to AIFA’s medicines appraisal committee.

The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) published the Update and extension of the criteria for applying the simplified medicine marketing-authorisation procedure (Aggiornamento e ampliamento dei criteri di applicazione della procedura semplificata per l'AIC dei medicinali) on 1 July. The revised criteria were established through Technical-Scientific Director Determination DTS 31/2026 and apply from publication.

AIFA introduced the simplified procedure in June 2023 for qualifying generic and hybrid applications. It was intended to avoid unnecessary duplicate assessment where supply status and classification could be assigned according to established criteria.

The expanded route now also covers qualifying biosimilars, fixed combinations, well-established-use applications, full dossiers, informed-consent applications, traditional herbal medicines and specified line extensions.

Applications remain subject to defined eligibility criteria. AIFA can refer cases requiring further assessment to the Scientific and Economic Committee for Medicines (Commissione scientifica ed economica del farmaco, CSE).

The extension forms part of AIFA’s wider effort to remove routine committee consideration where established rules can determine an administrative outcome. It should shorten the internal route for eligible applications and concentrate CSE review on cases requiring substantive scientific or economic judgement.

Source: Italian Medicines Agency
Link: Aggiornamento e ampliamento dei criteri di applicazione della procedura semplificata per l'AIC dei medicinali(Update and extension of the criteria for applying the simplified medicine marketing-authorisation procedure)
Date: 1 July 2026