The European Medicines Agency (EMA) has officially released its final "Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle" following a public consultation period.
This paper explores the potential applications and regulatory considerations for AI across the lifecycle of medicinal products, from drug discovery and clinical trials to post-authorisation activities such as pharmacovigilance.
Notably, the reflection paper highlights important considerations for data quality and representativeness in case of small populations: AI systems, particularly those used in clinical trials and treatment optimisation, must be carefully monitored to avoid biases that could affect minority groups, including children and individuals with rare diseases, that may be underrepresented in training datasets.
The paper encourages early engagement with regulatory bodies to address the potential risks associated with AI, particularly in high-risk patient groups.