Artificial Intelligence (AI) is rapidly becoming an integral part of scientific communication and information processes within the pharmaceutical sector. But what rules should be followed when AI is used in the development of promotional materials?
On 24 July 2026, the Italian Medicines Agency (AIFA) published its Guidance on the Use of Artificial Intelligence Systems in Promotional Materials, providing companies with practical recommendations for the responsible and compliant use of these technologies.
The Guidance clarifies that AI may be used as a supporting tool in the development of promotional materials, but it does not replace the company’s responsibility or the need for scientific and regulatory oversight. Content generated through AI systems must therefore undergo thorough review and remain consistent with the authorised product information. In particular, information must be based on reliable, pre-selected scientific and regulatory sources, with the Summary of Product Characteristics (SmPC) retaining its role as the primary reference document.
One of the key aspects of the AIFA Guidance is the principle of Human-in-the-Loop, whereby human involvement remains an integral part of the process. AI-generated outputs must therefore be reviewed, validated and approved by appropriately qualified personnel before being disseminated. The aim is to prevent the use of generative AI tools from resulting in the inclusion of unauthorised information, alterations to the meaning of approved data, or an unbalanced representation of the medicinal product’s efficacy and safety profile.
AIFA also highlights the importance of transparency in the use of AI and the ability to reconstruct the process through which promotional materials have been generated and reviewed. The use of these technologies should therefore be appropriately integrated into company processes and quality management systems, with adequate documentation of review and validation activities.
The AIFA Guidance represents a further step towards the structured use of Artificial Intelligence in the pharmaceutical sector. AI can offer significant opportunities in terms of efficiency, support for content development and process optimisation. However, its use must be supported by appropriate expertise, human oversight and robust control measures. For pharmaceutical companies, it is therefore essential not only to understand the potential of AI tools, but also to establish clear procedures and criteria governing their use within regulatory and quality processes.
Bio Chem Srl continuously monitors regulatory and legislative developments in the sector, providing its partners with up-to-date information and supporting companies in addressing the emerging challenges of scientific communication.
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