Published document record
2025 AI Observatory report
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Official PDF — unmodified source copy
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Download PDF — 25 pages (0.62 MB)EMA/67888/2026. Title page identifies this document.
Source: European Medicines Agency. Retrieved 2026-09-10.
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Official metadata
- Official title
- 2025 AI Observatory report
- Official reference
- EMA/67888/2026
- Document type
- Report
- Document date
- 2026-05-12
- Document date kind
- Document issue
- Document-date evidence
- European Medicines Agency · PDF cover: 12 May 2026, EMA/67888/2026. — Exact issue date printed on this version.
- Publication date
- 2026-06-04
- Publication-date evidence
- European Medicines Agency · AI Observatory reports: exact report First published 04/06/2026. — Establishes official publication of this version on 2026-06-04, before the 4 September 2026 cutoff.
- Legal status
- Non binding
- Legal-status evidence
- European Medicines Agency · PDF cover and pp.4-6, executive summary and AI policy/regulatory activities; official AI page, AI Observatory reports. — Non-legislative report, scientific guidance, strategic workplan or consultation text; not an act creating binding law.
- Language
- en
Research classifications
These are researcher classifications used to organise and analyse the corpus; they are not official EU metadata.
- Record level
- Principal
- Version status
- Final
- Temporal collection
- Contemporary EU AI policy
- Relevance class
- Direct AI relevance
- Policy stage
- Agenda setting
- Corpus tier
- Directly related
- Sectors
- Policy membership
Classification evidence
- Relevance class: Direct AI relevance · European Medicines Agency · PDF cover and pp.4-6, executive summary and AI policy/regulatory activities; official AI page, AI Observatory reports. — AI/ML is a substantive regulatory or sectoral subject.
- Sector tags: Health · European Medicines Agency · PDF cover and pp.4-6, executive summary and AI policy/regulatory activities; official AI page, AI Observatory reports. — Addresses medicines or health-insurance AI.
- Provenance tags: Authored by an EU agency or body · European Medicines Agency · PDF cover and pp.4-6, executive summary and AI policy/regulatory activities; official AI page, AI Observatory reports. — Produced within the named EU agency/body; named personal author credits remain separate.
- Provenance tags: Joint institutional · European Medicines Agency · Publication credits: HMA-EMA joint network or EMA and HMA joint publication. — Evidence identifies joint network preparation or publication; HMA is a national-authorities network.
- Provenance tags: Officially published · European Medicines Agency · Official record with linked English document. — Official EU endpoint distributes this independently citable English text.
Production provenance
- Provenance tags
- Named bibliographic authors
- European Medicines Agency · European Medicines Agency · PDF institutional title and imprint.
- Institutions and roles
-
- European Medicines Agency · Author · role evidence · PDF institutional title/imprint and substantive text.
- European Medicines Agency · Official host · role evidence · Official publication record and linked English PDF.
- European Medicines Agency · Publisher · role evidence · Official publication record and linked English PDF.
- Heads of Medicines Agencies · Publisher · role evidence · AI Observatory reports section: EMA and HMA publish annually.
Official sources and identifiers
- Official source · Publisher/host: European Medicines Agency
- Official source · Publisher/host: European Medicines Agency
Research assessment
- Inclusion rationale
- The entire report surveys AI guidance and policy, regulated-product applications, regulator tooling, collaborations, and research priorities for medicines regulation.
- Researcher notes
- 2025 is the activity year. EMA is credited on the cover; EMA and HMA are joint publishers. NDSG's monitoring role does not establish authorship.
- Review status
- verified
Relationships
No additional published relationships touch this record.
Verification
- Expanded evidence review
- Verified
- Reviewed by
- Yichen Hao
- Evidence review date
- 2026-09-05T23:48:11Z
The evidence review date is not a separate human sign-off date. Review credit and evidence-review actions
- Last verified: 2026-09-05T23:48:11Z · PDF cover: 12 May 2026, EMA/67888/2026. Official linked English manifestation reviewed.
- Last verified: 2026-09-05T23:48:11Z · PDF cover and pp.4-6, executive summary and AI policy/regulatory activities; official AI page, AI Observatory reports. English text inspected in web extraction or Node fetch plus pypdf; no retained file snapshot claimed.