Italy AIFA News

First AIFA Institutional Mission to Japan

AIFA President Robert Nisticò led the first-ever institutional mission to Japan, accompanied by Board Advisor Emanuele Monti and Dr. Armando Magrelli from the International Relations Office. The delegation held bilateral meetings with the Japanese Ministry of Health and PMDA (Pharmaceuticals and Medical Devices Agency) under President Yasuhiro Fujiwara, discussing shared regulatory challenges including research and innovation, longevity and chronic disease management, polypharmacy in elderly patients, AI in regulatory affairs, and healthcare system sustainability. Both nations, sharing universal healthcare systems, identified this mission as a foundation for future cooperation and best-practice exchange between Italian and Japanese pharmaceutical regulators.

AIFA Approves AIFA Ascolta and AIFA Incontra Stakeholder Engagement Regulations

AIFA has definitively approved and published in the Gazzetta Ufficiale the regulations for two new stakeholder engagement initiatives: AIFA Ascolta, a structured dialogue space for patient associations, networks, and federations focused on improving pharmaceutical access and health protection; and AIFA Incontra, a privileged dialogue channel between the Agency and institutional, scientific, industrial, and civic stakeholders in the pharmaceutical and health sectors. Both initiatives include a Transparency Register that will make meeting objectives, participants, final reports, and related documentation publicly available on the Agency's website. Meetings under both programs will typically be scheduled on a quarterly basis.

Precision Medicine: Tailored Therapies Replace One-Size-Fits-All Care

AIFA published a dossier on April 17, 2026, examining the clinical and economic impact of precision medicine and pharmacogenomics in Italy's National Health Service. The document highlights that 68% of Italians over 65 receive at least five different drug prescriptions and 28.5% take ten or more medications, increasing risks of drug interactions and adverse reactions. AIFA President Robert Nisticò emphasized that precision medicine should be a right for all patients, not a luxury, and positioned pharmacogenomics as a bridge between genetic knowledge and daily clinical practice.