EU AI Policy Observatory

Published document record

NDSG workplan 2026-2028 (v2.0)

PDF source copies

These PDFs are hosted here for continued access. Each is labelled as an unmodified official PDF or a converted reading copy. They are saved copies, not a live statement of the latest law or institutional endorsement. Official source links remain below.

  • Official PDF — unmodified source copy

    If the PDF does not display in your browser, Open PDF in a new tab or download it below. Both use the copy hosted on this site.

    Download PDF — 36 pages (0.61 MB)

    Version 2.0. Version 2.0 - February 2026.

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

    Copy provenance and reuse

    Unmodified source PDF. Source attribution and original notices are retained; see the source reuse terms. Source reuse terms. The database metadata licence does not replace these terms.

    SHA-256: 9a71bb191807f899f1a63867c4a30aec366b35d15bf1189413ea4f2ff793b101

Official metadata

Official title
NDSG workplan 2026-2028: Data and AI in medicines regulation
Official reference
Version 2.0
Document type
Work programme
Document date
2026-03-09
Document date kind
Publication
Document-date evidence
European Medicines Agency · EMA NDSG catalogue Workplan section: 2026-2028 workplan First published 09/03/2026; page update history records publication of the revised workplan that day. — Exact official publication/update fallback for this hosted revision; the cover supplies only an issue month.
Publication date
2026-03-09
Publication-date evidence
European Medicines Agency · EMA NDSG catalogue Workplan section: 2026-2028 workplan First published 09/03/2026; page update history records publication of the revised workplan that day. — Official publication of the v2.0 workplan on 9 March 2026, before the fixed cutoff.
Additional official dates
  • Cover issue: 2026-02 (month) · European Medicines Agency · PDF cover: VERSION 2.0, February 2026.
  • Institutional adoption: 2026-02 (month) · European Medicines Agency · PDF p.4 Introduction explicitly states that the current workplan was adopted by NDSG in February 2026; no exact adoption day established.
Version label
Version 2.0 - February 2026
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.17-21: 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 and Innovation; 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.20 Tools and Innovation: AI research priorities, tools development and innovation; p.21 sandbox simulation hackathon. — 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 Workplan section: 2026-2028 workplan First published 09/03/2026; page update history records publication of the revised workplan that day. — 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 and NDSG adoption are February 2026 at month precision. The 11 February meeting endorsed the plan in principle pending written adoption; it does not establish a final adoption day. 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 · 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.
  • Last verified: 2026-09-06T01:28:20Z · Prior review (5 September 2026, before this admission): Cover and pp.4-6 reviewed; Version 2.0, February 2026. Pending only because canonical predecessor endpoint is missing. Follow-up 6 September 2026: Full 36-page v2.0 inspected; cover February 2026 and p.4 adoption month/first annual revision verified; AI pp.17-21 checked. New retrieval 2026-09-06T01:12:53.554849+00:00, 640017 bytes, SHA-256 9a71bb191807f899f1a63867c4a30aec366b35d15bf1189413ea4f2ff793b101; local snapshot work/remaining-three-20260906/ndsg-2026-v2-0.pdf. The prior predecessor hold is resolved by admitting v1.4 and the evidenced revision edge.

Return to the Corpus