AIFA issues AI guidelines for pharmaceutical promotional materials

On 24 July 2026 the Italian Medicines Agency (AIFA), through its Office for Information on Medicines and Advertising (UIMVP), released experimental guidance on the use of artificial‑intelligence systems in drug promotional materials aimed at healthcare professionals. The guidelines cover content generated by generative AI models as well as interactive tools such as chat‑bots and virtual assistants, and require a continuous human‑in‑the‑loop check. Every AI‑generated output must be compared with the product’s Summary of Characteristics and authorised bibliographic sources, and the marketing‑authorisation holder and its scientific service remain fully responsible for compliance.

The document aligns the AI‑use rules with Italy’s Legislative Decree 219/2006, the EU AI Act (Regulation 2024/1689), and the GDPR (Regulation 2016/679). Companies must submit promotional material to AIFA at least ten days before dissemination, and the agency can prohibit or suspend any material that does not meet the regulatory standards.