Life Science & Pharma: GxP - AI
Draft EU GMP Annex 22, FDA's draft AI guidance for drugs and biologics, the joint FDA–EMA good AI practice principles, the EU AI Act, and related enforcement.
- Documents
- 11
- Authorities
- European Commission, ICH, FDA, EMA, European Union, ISPE, MHRA, NMPA
- Legal weight
- Law & regulation, GMP guide & annexes, Guidance & Q&A, Industry good practice, Warning letters
- Links on the map
- 3
- Crosswalks
- 2
- Next expected
- Target 31 Dec 2026: Annex 22 · AI
How to read this page
- 1. Scan across to see who issued each document, then down to see how binding it is, from law at the top to industry practice at the bottom.
- 2. Read the card: colour and words show status. Point at it for its full title and a plain explanation.
- Settings: open Status / Category Filters & Settings above the map for zoom, the keys, and Colour by.
- Colour by: switch the cards between Status and Category. In Category mode each Category has one colour, each Sub Category is a shade of it, and a card with two colours belongs to a combined Category.
- Filter with the keys: in the same panel, select one or more colours to highlight their cards and filter the crosswalks, instruments and relations below. Choices in a group widen the results, and Status and Category narrow each other. Counts in titles follow the filter. Select again to clear.
- Jump around: the bar under Latest in this area takes you to the map, crosswalks, instruments and relations.
- 3. Focus on a card: select it to fade everything else and list its links beside the map. Double-click to open the item, or right-click (press and hold on a touch screen) for options to open, compare or clear. Click empty space or press Esc to clear. Select a line to compare two documents.
- 4. Check clause by clause: crosswalks sit just below the map.
- Prefer text? The table and the list of relations give the same information, and work with a keyboard or screen reader.
- Red and green cards at the foot of the map are selected FDA warning letters, not rules. The window is 10 years, reflecting the potential lifecycle of a product. Current FDA data available via the automated system is limited to 2021 onwards. Note that this is dependent upon the FDA and thus may be impacted intermittently and historically regarding the list of related warning/close-out letters. Light green with (closed) means FDA issued a close-out letter.
- Unverified link means the SME Reviewer has not yet confirmed that link.
Start with
The most connected documents in this area, so a good place to begin.
- EMA AI reflection paper Final 2 links. EMA's current thinking on AI and machine learning for human and veterinary medicines, covering principles that apply at any stage of a medicine's lifecycle, from drug discovery to after authorisation.
- HMA-EMA AI workplan Final 2 links. Joint HMA and EMA workplan for artificial intelligence in medicines regulation, 2023 to 2028.
- EU AI Act Effective · phased 1 link. Horizontal EU law on AI systems, applying in phases.
- ICH Q9(R1) Final 1 link. The international guideline on quality risk management.
Latest in this area
The five newest dated changes. All changes in this area · Timeline
- 2 Aug 2026EU AI Act: Article 50 transparency duties apply (Art. 50(2) marking for systems already on the market: 2 Dec 2026, per the Omnibus)Effective · phased
- 27 Jul 2026EU AI Act: Digital Omnibus on AI, Regulation (EU) 2026/1744, in force (published in the Official Journal 24 Jul 2026); defers high-risk obligationsEffective · phased
- 30 Jun 2026Annex 22 · AI: EMA multistakeholder workshop on comments and generative AI (30 Jun–1 Jul)Draft
- 2 Apr 2026FDA AI warning letter: Warning letter 320-26-58 issued (2 Apr 2026)Warning letter
- 2 Apr 2026NMPA AI opinions: Issued by NMPAFinal
All 11 instruments
Weight means how binding the document is. Weight explained
| Instrument | Authority | Weight | Status | Category · Sub Category | Last verified |
|---|---|---|---|---|---|
| FDA AI guidance (drugs) | FDA | Guidance & Q&A | Draft | AI · Guidance | Not yet |
| EU AI Act | European Union | Law & regulation | Effective · phased | AI · Regulation | Not yet |
| Annex 22 · AI | European Commission | GMP guide & annexes | Draft | AI · Annex | Not yet |
| FDA AI warning letter | FDA | Warning letters | Warning letter | AI · Enforcement | Not yet |
| FDA–EMA AI principles | FDA, with EMA | Guidance & Q&A | Final | AI · Principles | Not yet |
| ICH Q9(R1) | ICH | Guidance & Q&A | Final | Quality foundations · Guideline | Not yet |
| MHRA AI regulation paper | MHRA | Guidance & Q&A | Final | AI · Guidance | Not yet |
| NMPA AI opinions | NMPA | Guidance & Q&A | Final | AI · Guidance | Not yet |
| ISPE GAMP 5, 2nd ed. | ISPE | Industry good practice | Industry guide | CSV · Industry guide | Not yet |
| HMA-EMA AI workplan | EMA | Guidance & Q&A | Final | AI · Guidance | Not yet |
| EMA AI reflection paper | EMA | Guidance & Q&A | Final | AI · Guideline | Not yet |
Map
Status / Category Filters & Settings
Lines
- Solid: interprets, implements, complements and other links
- Dashed: replaces or will replace
- Dotted: informs
Cards
- Solid card: the lead authority
- Dashed card: a co-author of a joint publication
Select one or more colours to highlight them and filter the lists on this page. Select again to clear.
Status
Category and Sub Category
What each Category means · What each link means · What each status means
EU · EC / EMA (5)PIC/S · ICH · ISPE (2)US · FDA (3)UK · MHRA (1)Other national (1)Law & regulation
bindingGMP guide & annexes
binding in the EU via GMP directivesGuidance & Q&A
current thinking, not bindingIndustry good practice
cite onlyWarning letters
selected FDA letters, last 10 years. A flag, not a rule
bindingGMP guide & annexes
binding in the EU via GMP directivesGuidance & Q&A
current thinking, not bindingIndustry good practice
cite onlyWarning letters
selected FDA letters, last 10 years. A flag, not a rule
Crosswalks in this area
A crosswalk matches clauses in one document with clauses on the same topic in another. Open one to see it row by row. "None" means that document has no matching clause, and "Difference" is our own short note, not a legal comparison.
EU GMP Annex 22 (draft) ↔ FDA AI guidance for drugs (draft) 11 topics
Annex 22 · AI compared with FDA AI guidance (drugs). Relationship types after NIST IR 8477 (STRM): equal, intersects, superset, subset, none. Drafted with AI from the official texts. Strength is a placeholder and is hidden until the SME Reviewer has reviewed the mapping. Both are drafts. Annex 22 covers GMP models. FDA covers AI that supports regulatory decisions, so their scopes differ.
| Annex 22 · AI | Topic | FDA AI guidance (drugs) | Relationship | Difference |
|---|---|---|---|---|
| §1 | Scope | II | Intersects | Annex 22 is limited to static, deterministic models in GMP and excludes generative AI. FDA covers models supporting regulatory decisions, and excludes discovery. |
| §3 | Intended use and context of use | IV.A Steps 1–2 | Intersects | Annex 22 requires a description and an SME. FDA frames a question of interest and context of use. |
| §2.3 | Risk basis | IV.A Step 3 | Intersects | Annex 22 uses patient safety, product quality and data integrity. FDA uses model influence and decision consequence. |
| §4 | Metrics and acceptance criteria | IV.A Step 4 | Intersects | Annex 22 adds that criteria should be at least as high as the replaced process. |
| §5, §6 | Test data and independence | IV.A Step 4 | Superset | Annex 22 is more detailed on independence of data and staff. |
| §7 | Test plan, execution and deviations | IV.A Steps 5–7 | Intersects | Both require a plan, deviations recorded and a conclusion. |
| §8 | Explainability | None | No match | Annex 22 has a section on feature attribution. FDA has no matching section. |
| §9 | Confidence scores and thresholds | None | No match | Annex 22 has a section. FDA has no matching section. |
| §10.1–10.4 | Change and monitoring in operation | IV.B | Intersects | Annex 22 lists controls. FDA discusses life cycle maintenance in certain contexts of use. |
| §3.3, §10.5 | Human review | None | No match | Annex 22 addresses human-in-the-loop use directly. |
| None | Early engagement with the regulator | IV.C | No match | FDA-specific section. |
EU GMP Annex 22 (draft) ↔ FDA and EMA good AI practice principles 10 topics
Annex 22 · AI compared with FDA–EMA AI principles. Relationship types after NIST IR 8477 (STRM): equal, intersects, superset, subset, none. Drafted with AI from the official texts. Strength is a placeholder and is hidden until the SME Reviewer has reviewed the mapping. Annex 22 is a draft GMP text. The principles are high-level and non-binding.
| Annex 22 · AI | Topic | FDA–EMA AI principles | Relationship | Difference |
|---|---|---|---|---|
| §2.1 | People and expertise | Principle 5 | Intersects | Annex 22 names the roles. The principle is general. |
| §2.3 | Risk basis | Principle 2 | Intersects | Both apply effort according to risk. |
| §3 | Intended use and context of use | Principle 4 | Superset | Annex 22 is more detailed, including input sample space and subgroups. |
| §4, §7 | Performance assessment | Principle 8 | Intersects | The principle covers the complete system, including human-AI interaction. |
| §5, §6 | Data and data documentation | Principle 6 | Intersects | Annex 22 focuses on test data. The principle covers data provenance and processing more widely. |
| §8 | Explainability | Principle 7 | Intersects | The principle refers to interpretability and explainability in development. |
| §10 | Life cycle and monitoring | Principle 9 | Intersects | Both expect monitoring, including for drift. |
| §3.3, §10.5 | Human oversight | Principle 1 | Intersects | Annex 22 is about operator responsibility. The principle is about human-centric values. |
| None | Adherence to standards | Principle 3 | No match | No matching Annex 22 section. |
| None | Clear information for users and patients | Principle 10 | No match | No matching Annex 22 section. |
Relationship key
- Equal
- The two clauses cover the same ground.
- Intersects
- They overlap, but each covers something the other does not.
- Superset
- The first document's clause covers everything in the second, and more.
- Subset
- The first document's clause covers only part of the second.
- No match
- One document has no matching clause.
Relations on this map
The same links as the lines above, in words. What each link means
- ICH Q9(R1) is the risk basis for EMA AI reflection paper· Compare ICH Q9(R1) and EMA AI reflection paper Unverified link
- HMA-EMA AI workplan is related to EU AI Act· Compare HMA-EMA AI workplan and EU AI Act Unverified link
- HMA-EMA AI workplan is related to EMA AI reflection paper· Compare HMA-EMA AI workplan and EMA AI reflection paper Unverified link