The publication of the reflection paper on the use of artificial intelligence (AI) in the medicinal product lifecycle is now available, following public consultation and extensive feedback from stakeholders, including regulatory bodies and organizations. The paper outlines key principles for the safe and effective application of AI and machine learning (ML) throughout the stages of medicine development, from discovery to post-authorization. It stresses that while AI can improve many aspects of this lifecycle, it is crucial that its use does not undermine trust in regulatory decisions or patient safety.

The paper aligns with EU legal requirements concerning AI, data protection, and medicines regulation. A multistakeholder public workshop on AI occurred on November 5, 2024 and discussed future steps related to the paper and the possibility of additional guidance. This reflection paper was developed by the Methodology Working Party of the Committee for Medicinal Products for Human Use (CHMP), with contributions from the Big Data Steering Group. It has been adopted by both the CHMP and the Committee for Veterinary Medicinal Products (CVMP), as part of the ongoing efforts to strengthen data-driven regulation across the European Medicines Regulatory Network.1

Read more here.

References

  1. Artificial intelligence | European Medicines Agency (EMA). (n.d.). European Medicines Agency (EMA). https://www.ema.europa.eu/en/about-us/how-we-work/big-data/artificial-intelligence#ai-in-medicinal-product-lifecycle-reflection-paper-68368

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