EU AI Policy Observatory

Published document record

NDSG workplan 2025-2028 (v1.4)

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    Version 1.4. Version 1.4 - July 2025.

    Source: European Medicines Agency. Retrieved 2026-09-10.

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    SHA-256: c4218dcd0f9a55c1e4d04d92be2866e7f36aa3ea451a1d85691d3fcaa44ff52c

Official metadata

Official title
NDSG workplan 2025-2028: Data and AI in medicines regulation
Official reference
Version 1.4
Document type
Work programme
Document date
2025-07-22
Document date kind
Publication
Document-date evidence
European Medicines Agency · EMA NDSG catalogue Previous versions panel: linked 2025-2028 workplan Last updated 22/07/2025; PDF cover identifies Version 1.4, July 2025. — Exact official publication/update fallback for this hosted revision; the cover supplies only an issue month.
Publication date
2025-07-22
Publication-date evidence
European Medicines Agency · EMA NDSG catalogue Previous versions panel: linked 2025-2028 workplan Last updated 22/07/2025; PDF cover identifies Version 1.4, July 2025. — Document-specific hosted-revision publication/update fallback of 22 July 2025 for v1.4; not the lineage's May first publication.
Additional official dates
Version label
Version 1.4 - July 2025
Legal status
Non binding
Legal-status evidence
European Medicines Agency · PDF cover identifies workplan; p.4 Introduction describes advisory-group activities and annual updating; AI workstream lists planned deliverables. — Non-binding institutional work programme, not a legislative act.
Language
en

Research classifications

These are researcher classifications used to organise and analyse the corpus; they are not official EU metadata.

Record level
Version
Version status
Revised
Temporal collection
Contemporary EU AI policy
Relevance class
Direct AI relevance
Policy stage
Coordination
Corpus tier
Directly related
Sectors
  • Health
  • Public administration
  • Research and innovation
Policy membership
  • EU AI policy pathway

Classification evidence

  • Relevance class: Direct AI relevance · European Medicines Agency · PDF pp.17-22: Artificial Intelligence workstream; p.18 overview; p.19 Guidance, policy and product support. — Dedicated substantive AI governance, guidance and tools workstream.
  • Sector tags: Health · European Medicines Agency · PDF p.4 Introduction and pp.18-19 AI overview and guidance: human and veterinary medicines, public and animal health. — AI evaluation and safe use throughout the medicines lifecycle.
  • Sector tags: Public administration · European Medicines Agency · PDF p.20 Tools & technologies; p.21 Collaboration and change management. — AI tools, regulatory staff capacity and network governance for medicines authorities.
  • Sector tags: Research and innovation · European Medicines Agency · PDF p.22 Experimentation: network AI research priorities and experimentation cycles; p.21 academia collaboration. — Explicit AI research priorities, experimentation and collaborative innovation.
  • Provenance tags: Authored by an EU agency or body · European Medicines Agency · PDF cover and p.4 Introduction: Joint HMA/EMA Network Data Steering Group. — Workplan authored by the joint regulatory steering group involving EMA; HMA is a network of national authorities.
  • Provenance tags: Joint institutional · European Medicines Agency · PDF cover credits Joint HMA/EMA Network Data Steering Group. — Explicit joint network authorship, distinct from EMA hosting and publication.
  • Provenance tags: Officially published · European Medicines Agency · EMA NDSG catalogue Previous versions panel: linked 2025-2028 workplan Last updated 22/07/2025; PDF cover identifies Version 1.4, July 2025. — EMA officially distributes this independently citable English workplan version.

Production provenance

Provenance tags
  • Authored by an EU agency or body
  • Joint institutional
  • Officially published
Named bibliographic authors
Institutions and roles

Official sources and identifiers

Previous and next versions

Research assessment

Inclusion rationale
Joint HMA/EMA NDSG institutional workplan with an extensive dedicated AI workstream for the European medicines regulatory network, including AI guidance, regulatory tools and research.
Researcher notes
The cover issue is July 2025 at month precision. The 22 July catalogue last-update date is the document-specific hosted-revision publication fallback, not an established issue or adoption day. The first workplan's March adoption and 7 May first publication do not date this v1.4 manifestation. EMA's official catalogue links v1.4 as the previous version; v2.0 is the first annual revision. Earlier v1.0-v1.3 manifestations have not been recovered and no complete version history or canonical parent is invented. Future deliverables remain plans. Reviewer attribution denotes AI-assisted evidence review.
Review status
verified

Relationships

No additional published relationships touch this record.

Verification

Expanded evidence review
Verified
Reviewed by
Yichen Hao
Evidence review date
2026-09-06T01:28:20Z

The evidence review date is not a separate human sign-off date. Review credit and evidence-review actions

  • Last verified: 2026-09-06T01:28:20Z · Official previous-version PDF: Version 1.4, July 2025; all 37 pages extracted, cover, introduction and AI workstream pp.17-22 checked. 829312 bytes; SHA-256 c4218dcd0f9a55c1e4d04d92be2866e7f36aa3ea451a1d85691d3fcaa44ff52c. Local snapshot work/remaining-three-20260906/ndsg-2025-v1-4.pdf records September retrieval bytes, not historical byte identity. Catalogue last update 22 July 2025 is the version-specific publication fallback; the May first publication belongs to the lineage.
  • Last verified: 2026-09-06T01:28:20Z · EMA NDSG catalogue gives first published 09/03/2026 and links predecessor 2025-2028. Follow-up 6 September 2026: Previous-version download independently identified as Version 1.4, July 2025, last updated 22/07/2025. Current workplan first published 09/03/2026 and revision publication corroborated by page update history. Earlier manifestations remain unrecovered; publication dates are version-specific.

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