EMA · Life Science & Pharma: GxP - AI
Multi-annual artificial intelligence workplan 2023-2028 (HMA-EMA)
Final AI · Guidance Last verified: not yet · Source last checked 3 Nov 2026
- Issued by
- EMA
- Category
- AI
- Sub Category
- Guidance
- Legal weight
- Guidance & Q&A
- Reuse
- EMA reuse
The plan for how EU medicines regulators will use and oversee AI up to 2028. It shows direction and creates no duties for companies.
How to read this page
- The line under the title explains in plain words what this item is for. The coloured label beside its status gives its Category, its main subject, and Sub Category, the type of document, in the same colours as the maps.
- Status comes from the latest dated event below, and each event links to its source.
- Lifecycle shows the steps so far, then any expected target. Targets are not facts.
- In plain English is our own summary, not the official text. Where we have read the document in detail, a fuller profile follows, with its context, scope, contents and key points.
- Related shows links to other documents. Select Compare to see two side by side.
Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- Published
In plain English
Joint HMA and EMA workplan for artificial intelligence in medicines regulation, 2023 to 2028. It is a plan, not a requirement.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
This workplan from the HMA-EMA Big Data Steering Group, version 1 dated November 2023, sets out how the European medicines regulatory network plans to use and regulate AI to 2028. It is a plan, not a requirement.
Who and what it applies to
Readers following EU regulatory plans on AI.
What it contains
- Guidance, policy and product support
- Consulting on and revising the AI reflection paper, developing lifecycle and domain guidance, preparing for the AI Act, and setting up an observatory.
- Tools and technologies
- Knowledge mining and large language models for internal regulatory use, and analytics capability.
- Collaboration and change management
- International and EU collaboration, and training.
- Experimentation
- Research, and principles for responsible internal AI use.
Key points
- It signals direction, not obligations.
- It includes regulators' own use of AI, not only rules for industry.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Use it to anticipate EU guidance, and check it against the current EMA website.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 18 Dec 2023 | Published | Final | Source for Published |
Related
How other documents connect to this one. Links explained
- Related to EU AI Act· Compare with EU AI Act Unverified link
- Related to EMA AI reflection paper· Compare with EMA AI reflection paper Unverified link
Official source
The official text always prevails over anything on this site.
Source: EMA. Summary adapted from the original.
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