LIFE SCIENCES | New AIFA’s Guidelines on the Use of Artificial Intelligence in Promotional Materials

On 24 July 2026, the Italian Medicines Agency (AIFA) published new Guidelines aimed at providing pharmaceutical companies with practical guidance on the admissibility and use of artificial intelligence (AI) systems in the preparation and use of promotional materials intended for healthcare professionals. In doing so, AIFA addresses the evolving landscape of promotional communications and provides an initial regulatory framework to tackle the specific issues arising from the use of AI in the pharmaceutical sector.

The guidelines apply both to promotional materials developed with the support of generative AI systems and to promotional materials that directly incorporate AI technologies, such as chatbots, virtual assistants, or other interactive tools designed to provide information on medicinal products to healthcare professionals.

The document clarifies that the use of AI does not constitute an exception to the existing regulatory framework and must fully comply with the applicable legal requirements. Pharmaceutical companies remain under the obligation to file promotional materials with AIFA. Although such materials are not subject to prior review or approval by the Agency, responsibility for ensuring their compliance with the applicable legislation rests exclusively with the marketing authorisation holder (MAH)

The guidelines also reiterate the fundamental principles governing the advertising of medicinal products, including the prohibition of misleading claims, the obligation to ensure the scientific accuracy of the information provided, and the prohibition on including content unrelated to the promotional purpose of the medicinal product.

Newsletter n. 121 – August/September 2026