24 August 2023

EMA released a draft Reflection Paper on the utilization of Artificial Intelligence

On July 19, 2023, the European Medicines Agency (EMA) released a draft Reflection Paper on the utilization of Artificial Intelligence (AI). Consultations regarding the integration of AI in both human and veterinary medicines are open for discussion. During this consultation period, EMA will host a workshop on AI in the context of medicines, scheduled for November 20-21, 2023. Stakeholders are invited to contribute their valuable comments on this paper until December 31.

The reflection paper outlines EMA’s experience in a rapidly evolving field. It should be reviewed considering relevant laws and regulations. AI and machine learning (ML) tools, if used correctly, can effectively support data acquisition, transformation, analysis, and interpretation of data within the lifecycle of medicinal products. Employing a risk-based approach can aid developers in identifying and manage risks associated with AI and ML tools throughout their lifecycle.

The marketing authorization applicant or MAH is responsible for ensuring that all algorithms, models, datasets, etc. used are fit for purpose and meet ethical, technical, scientific, and regulatory standards.

The document covers the following topics:

·        AI in the lifecycle of medicinal products

·        Regulatory interactions

·        Technical aspects

·        Governance

·        Data protection

·        Integrity aspects

·        Ethical aspects and trustworthy AI


AI has become a hot topic in recent years, thanks in part to the success of ChatGPT and the resulting media coverage. Massive amounts of data are generated on a daily basis presenting potential resources for supporting medicines regulation. In several aspects such as data management, governance, and statistical stringency, currently established regulatory principles, guidelines, and best practices are directly applicable to AI/ML and efforts should be made in all organisations to reciprocally integrate data science competence with the respective fields within medicines development and pharmacovigilance.