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Artificial Intelligence In European Medicines Regulation

 |  November 21, 2022

By Philip A. Gines, Ralf Herold, Luis Pinheiro & Zaide Frias, European Medicines Agency, Amsterdam.

Artificial intelligence tools are increasingly being applied in the development and use of medicines. Here, we provide a regulatory perspective on such applications.

The ability of artificial intelligence (AI) tools to generate new insights and improve processes could enhance the development and regulation of medicines in areas ranging from preclinical research to pharmacovigilance. Many applications of AI tools have the potential to impact the benefit–risk ratio of medicinal products, and so intersect with the mandate of regulatory agencies such as the European Medicines Agency (EMA) to assure the quality, safety and efficacy of medicines (Supplementary Table 1). For example, an AI tool could be used to predict the relationship between different patient characteristics and a medicine’s safety and efficacy, and thereby help optimize the patient populations in clinical trials accordingly. Other uses could include AI-based classification of individual case safety reports by seriousness, or supporting medicine administration; for example, a digital insulin pump that uses AI as part of its administration, monitoring or feedback control. AI applications, therefore, have great potential for public and animal health.

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