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EMA · Reflection paper on AI
AI across the medicinal product lifecycle. Non-binding.
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Citation: EMA CHMP/CVMP Reflection Paper on the use of AI in the medicinal product lifecycle, September 2024
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What the reflection paper says, and how far it reaches
European Medicines Agency, CHMP and CVMP, Reflection Paper on the use of artificial intelligence in the medicinal product lifecycle, September 2024. Non-binding, and broader in scope than the FDA draft:
- Lifecycle-wide scope, discovery included
- Unlike FDA’s January 2025 draft, which excludes discovery, the reflection paper addresses the lifecycle as a whole. The difference between the two documents is worth knowing before assuming either position applies.
- A human-centric approach
- The paper frames AI use around human responsibility rather than model performance alone.
- Dossier expectations for higher-risk uses
- Where a model carries more weight in a regulatory decision, more is expected in the submission about how it was developed and used.
- Status
- A reflection paper sets out the agency’s current thinking. It is not a binding requirement and should not be described as one.
Non-binding. Cited here because it is the clearest statement that the European position covers discovery, where the current US draft does not, and because that asymmetry is often reported the wrong way round.
Built against the primary text published by the EMA. Verified 17 August 2026.
This is the duty on the business. For what a lawyer in Europe must disclose about using AI in a filing, see Europe: the EU AI Act, the CCBE guides, and what Germany tells its lawyers.