European Medicine Regulation and Artificial Intelligence: Drug innovation in perspective

Artificial Intelligence (AI) tools promise significant benefits in various fields and aspects of human lives. Innovative development and more efficient use of medicinal products is a promising field for the application of AI tools. European Medicine Agency (EMA) early recognized the dynamic role of AI in various fields such as: in preclinical evidence generation such as pharmacodynamics, or in clinical evidence generation, such as identifying the relationship between patient characteristics and drug efficacy, or in pharmacovigilance through AI-based screening of real-world data for adverse events, and other applications. However, the use of AI tools poses also various regulatory challenges. In a recently published comment in Nature Reviews Drug Discovery, Hines et al., discuss the key initiatives of the European Medicine Regulatory Network (EMRN), the basic four principles that will guide the AI tools regulatory framework, as well as the key points in the EU perspective on AI. Ultimately, as it is discussed in the article, the key aim is to build a EU roadmap for regulation of AI for medicines, including regulatory frameworks that ensure the protection of participants in trials and patients treated in routine care, and incorporate regulations related to AI algorithm explainability, interpretability, performance, validity, ethical aspects, and reliability among others.
You can find the article here.