EMA Draft Paper: AI for Safer Medicine

The EMA has released a draft reflection paper on the use of artificial intelligence (AI) and machine learning (ML) to facilitate the safe and effective development, regulation, and use of medicines. 

AI and ML tools can assist in data acquisition, transformation, analysis, and interpretation. They might replace or refine animal models during preclinical development, aid in patient selection for clinical trials based on disease characteristics, facilitate data recording and analysis for regulatory submission.

However, this wide-ranging application introduces challenges such as understanding algorithm design, addressing possible biases, mitigating technical failures, and considering the broader implications on healthcare and AI adoption. The paper emphasizes a human-centric approach, adherence to existing legal requirements, ethical considerations, and respect for fundamental rights in all AI and ML deployments for medicines.

If AI/ML systems are expected to impact the benefit-risk balance of a medicine during development, evaluation, or monitoring, EMA advises to seek early regulatory guidance through established methods. 

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