Tool: Timeline Maps · Life Science & Pharma: GxP - AI
Every dated event, from the earliest to the latest expected, with one row per item so you can follow each document from start to finish.
How to read this page
- Each row is one item, A to Z, grouped by authority. An older version and its replacement share a row.
- Time runs left to right, on a real scale, and each year from 2020 is drawn wider. Each marker is one event, coloured by the status after it.
- Solid lines join the steps of one version. Dashed lines lead from an older version to its replacement.
- Dashed diamonds are targets: expected dates, not facts. The red line is today.
- Warning letters have their own group under FDA, closed until you open it. Letters are selected, from a 10-year window. 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.
- Select a row or marker to focus on it and list its steps. Double-click to open the item, or right-click for options. Click empty space or press Esc to clear.
- Filter with the keys: open Status / Category Filters & Settings above the map, then select one or more colours to highlight them and filter the events below. Zoom and the keys are there too. Choices in a group widen the results, and Status and Category narrow each other. Select again to clear.
- Jump around: the bar above the map takes you to the chronological map or the events.
- Prefer text? The list has the same events, with links, and also shows routine checks.
Chronological map
Status / Category Filters & Settings
Markers and lines
- Solid marker: a dated event
- Dashed diamond: a target, expected and not a fact
- Solid line: the steps of one version
- Dashed line: an older version leading to its replacement
Select one or more colours to highlight them and filter the events below. Status applies to each event. Select again to clear.
Status
Category and Sub Category
TitleCategorySub CategoryPurpose
EU · EC / EMA (4)
EC Annex 22 · AIAIAnnexA proposed new EU GMP annex on using AI models in medicine manufacturing. It would be the first EU GMP text written for AI, and is still a draft.
EMA AI reflection paperAIGuidelineEMA's thinking on using AI across a medicine's life, from discovery to after approval. It is a reflection paper, so it is not a binding rule.
EU AI ActAIRegulationThe EU's general law on artificial intelligence, covering all sectors. What it requires depends on the risk of the AI system and the role of the company.
HMA-EMA AI workplanAIGuidanceThe plan for how EU medicines regulators will use and oversee AI up to 2028. It shows direction and creates no duties for companies.
PIC/S · ICH · ISPE (3)
ICH Q9(R1)Quality foundationsGuidelineThe international guideline on quality risk management. It explains how to find, assess and control risks to medicine quality.
ISPE GAMP 5, 2nd ed.CSVIndustry guideThe industry's best-known guide to a risk-based way of validating GxP computerised systems. It is good practice, not law.
ISPE GAMP AI guideAIIndustry guideThe industry's guide to developing and using AI-enabled computerised systems in GxP work. It is good practice, not law.
US · FDA (2)
FDA AI guidance (drugs)AIGuidanceFDA's draft guidance on showing an AI model can be trusted when it supports decisions about a drug's safety, effectiveness or quality.
FDA–EMA AI principlesAIPrinciplesTen high-level principles agreed by FDA and EMA for using AI well across a medicine's life. They are not binding.
Warning letters and close-outs (1)
FDA AI warning letterAIEnforcementAn FDA warning letter to one firm that used AI to write GMP documents without proper review. It shows how FDA applies existing rules to AI.
UK · MHRA (1)
MHRA AI regulation paperAIGuidanceThe UK regulator's paper on how it applies the government's AI principles to medicines and medical devices. It is policy, not a rule.
Other national (1)
NMPA AI opinionsAIGuidanceChina's plan for how regulators will use AI in their own work on medicines, such as review and inspection. It is aimed at regulators, not companies.
Time runs left to right. Each year from 2020 is drawn wider, because that is where most events fall. How to read the timeline · What each Category means
All 26 events
2028
- Target 2 Aug 2028EU AI Act: Annex I (product-embedded, e.g. devices) high-risk obligations applyExpected: Effective · phased
2027
- Target 2 Dec 2027EU AI Act: Annex III high-risk obligations applyExpected: Effective · phased
2026
- Target 31 Dec 2026Annex 22 · AI: Target: final text to European Commission (Q4 2026)Expected: Final text to EC
- 30 Oct 2026FDA AI guidance (drugs): Checked: still draft; no final guidance foundDraft
- 29 Sep 2026Annex 22 · AI: Checked: not yet in EudraLex Vol 4Draft
- 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
- 14 Jan 2026FDA–EMA AI principles: Published jointly by FDA and EMA (non-binding principles)Final
2025
- 7 Oct 2025Annex 22 · AI: Public consultation closedDraft
- 7 Jul 2025Annex 22 · AI: Draft published for public consultationDraft
- ~1 Jul 2025GAMP AI guide: Published (July 2025, month only on ISPE's public page)Industry guide
- 7 Jan 2025FDA AI guidance (drugs): Draft guidance published (comments closed 7 Apr 2025)Draft
2024
- 30 Sep 2024EMA AI reflection paper: Final version publishedFinal
- 9 Sep 2024EMA AI reflection paper: Final version adopted by CHMPFinal
- 1 Aug 2024EU AI Act: Entered into force (obligations phased)Effective · phased
- 30 Apr 2024MHRA AI regulation paper: PublishedFinal
2023
- 31 Dec 2023EMA AI reflection paper: Public consultation closedDraft
- 18 Dec 2023HMA-EMA AI workplan: PublishedFinal
- 19 Jul 2023EMA AI reflection paper: Draft released for public consultationDraft
- 18 Jan 2023ICH Q9(R1): Reached Step 4 (final)Final
2022
- 29 Jul 2022ISPE GAMP 5, 2nd ed.: Second edition published (29 Jul 2022)Industry guide
2021
- 18 Nov 2021ICH Q9(R1): Q9(R1) released for public consultation at Step 2Draft
2005
- 9 Nov 2005ICH Q9(R1): Original Q9 reached Step 4Final