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AIFA begins review of long-running monitoring registries to decide on revision or closure

🇮🇹 AIFA · Thu 29 Oct 2026

Italy's medicines agency is checking whether registries active for several years still serve their original purpose, with closures to be announced on its website.

The Italian Medicines Agency (AIFA) has started a review of the monitoring registries that have been active for several years. The agency published the announcement on 29 October 2026.

According to AIFA, the exercise forms part of the ongoing update of its Registry System and sits within a wider evolution of that system under a new regulatory framework. The stated aims are effectiveness, sustainability and the ability to support the agency's monitoring and evaluation of medicines.

The review will test whether long-standing registries still meet the purposes for which they were set up, or whether they can be revised or closed. AIFA says it will weigh the evidence gathered over the years, the characteristics of the diseases and medicines concerned, and changes in the regulatory context. Factors named include the length of monitoring, how the medicine is used and any regulatory procedures under way, among others.

AIFA presents rationalisation as a way to simplify monitoring and cut the burden of completing registry forms, keeping data collection focused where it is most useful. It describes the registries as tools that support prescribing appropriateness, check reimbursement conditions and gather information on how therapies are used in clinical practice.

Decisions to close registries will be communicated through the agency's website. The source does not name specific registries, give a timetable or set out how many are in scope.

What it means for your team

  • Marketing authorisation holders with products tied to long-running AIFA registries should check which of their monitoring registries may be affected, though no list has been published.
  • Watch the AIFA website, where closure decisions will be announced, and plan for possible changes to reimbursement-linked data collection.
  • Ongoing regulatory procedures for a product are among the factors AIFA will consider, so teams may wish to keep their registry status aligned with any open Italian procedures.
  • Clinical and market-access teams could see a lighter form-filling workload if registries are closed or streamlined, but no outcomes have been announced.

Official source: AIFA ↗

Article written by VigiEye from the official source (AIFA). AI-assisted; check the source before acting.

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