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EMA · Reflection paper on AI
AI across the medicinal product lifecycle. Non-binding.
Instrument: Reflection paper, nonbindingApplies to: Medicinal product development and lifecycle (EU).
What the signed record shows
The human decisions taken on AI output across the lifecycle, recorded as they were made.
The proof is a signed, tamper-evident record. Anyone can check it, free, without an account, and nothing has to leave the building to make it. Evidence, not a promise.
Citation: EMA CHMP/CVMP Reflection Paper on the use of AI in the medicinal product lifecycle, September 2024
What to do about it
Keep the evidence this asks for, as the work happens.
A consequential AI-proposed action is checked against the human authority in force at that moment, and the decision leaves a signed record that a third party can verify independently, offline, without Regulayer. It runs inside your own environment and nothing has to leave it.
Life sciences: how the control worksOr verify a real record, free →
Part of the Regulayer proof catalogue: 143 laws and standards, one sealed engine. This page is a product description, not legal advice.
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.
