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EU GMP · Annex 22 (draft)
Artificial intelligence in GMP. Consultation draft, not in force.
Instrument: Draft GMP guidance, not in forceApplies to: Pharma manufacturing (EU).
What the signed record shows
The AI output, and the human review decision taken on it, recorded together for a GMP-relevant action.
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: draft Annex 22, EudraLex Volume 4 consultation opened 7 July 2025
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 2025 consultation draft covers, and what is still moving
EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice. Annex 22, Artificial Intelligence, opened for stakeholder consultation by the European Commission on 7 July 2025 and closed on 7 October 2025. It is the first AI-specific GMP annex. Everything below describes the 2025 consultation draft as it was published, and the last row describes what has happened since:
- The 2025 draft did not apply to generative AI or large language models
- As published for consultation, the draft excluded generative AI and LLMs. Anyone citing Annex 22 today as the settled European rule for governing an LLM in a regulated workflow is citing a document that, in that form, did not reach them.
- The 2025 draft did not cover continuously adapting models
- Models that continue to learn in use sat outside it as drafted.
- Critical applications were confined to static, deterministic models
- For critical GMP applications the draft confined use to static models with deterministic output, which placed probabilistic-output models outside that category.
- What it did address: the human review decision as a record
- Within its scope, the draft addressed records of the AI output and of the human review decision taken on it. The pattern it described is that the system proposes and an authorised human disposes.
- What has moved since: the scope is under active reconsideration
- The European Medicines Agency held a multistakeholder workshop on 30 June and 1 July 2026 on expert contributions to the Annex 22 guidance, held in part because consultation responses supported potentially enabling generative AI and large language models, with the agency considering control and mitigation approaches including guardrails. The exclusions above should therefore be read as the 2025 draft position, not as a settled outcome.
Status: consultation draft, not in force, and its scope is still being decided. Nothing here describes a current legal duty, and no record can make anyone compliant with a text that does not exist in final form. Because the treatment of generative models is exactly the part still moving, this page states the 2025 draft position and dates it rather than presenting it as permanent. What holds either way is narrower and older than Annex 22: where a model proposes and a person disposes, the decision and the authority behind it are worth recording as they happen.
Built against the European Commission consultation guideline for Annex 22, and the EMA workshop on expert contributions to Annex 22 guidance development, 30 June and 1 July 2026. Verified 17 August 2026.
