Tool: Regulation Maps
Each regulatory area has its own interactive map. A map shows who issued each document, how binding it is, where it stands today and how it connects to the others. Clause-by-clause crosswalks sit below each map.
How to read this page
- Choose an area below, then open its map.
- Each map places documents by authority (across) and legal weight (down), with lines for the links between them. A button colours the cards by Status or Category, and the colour keys filter the page.
- Each area page also has a table of every document, its crosswalks, and the latest changes.
- A document can sit in more than one area, so the counts can overlap.
Available now
Life Science & Pharma: GxP - CSV & Data Integrity
Part 11, Annex 11 and its revision, Chapter 4, and data integrity guidance from FDA, MHRA and PIC/S, ICH Q9(R1), GAMP 5 and FDA warning letters.
- Documents
- 53
- Links
- 46
- Crosswalks
- 5
- Next expected
- Target 31 Dec 2026
- 5 Draft
- 21 Final
- 7 In force
- 1 Superseded
- 2 Industry guide
- 11 Warning letter
- 6 Warning letter (closed)
Crosswalks: EU GMP Annex 11 (2011) ↔ Annex 11 revision (draft); EU GMP Chapter 4 (2011) ↔ Chapter 4 revision (draft); FDA data integrity Q&A ↔ MHRA GxP data integrity guidance; 21 CFR Part 11 ↔ EU GMP Annex 11 (2011); 21 CFR 211.68 ↔ EU GMP Annex 11 (2011).
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
- Links
- 3
- Crosswalks
- 2
- Next expected
- Target 31 Dec 2026
- 2 Draft
- 6 Final
- 1 Effective · phased
- 1 Industry guide
- 1 Warning letter
Crosswalks: EU GMP Annex 22 (draft) ↔ FDA AI guidance for drugs (draft); EU GMP Annex 22 (draft) ↔ FDA and EMA good AI practice principles.
Coverage by authority
How many documents each authority has in each area, including joint publications.
| Authority | Life Science & Pharma: GxP - CSV & Data Integrity | Life Science & Pharma: GxP - AI |
|---|---|---|
| European Commission | 8 | 1 |
| PIC/S | 4 | 0 |
| ICH | 3 | 1 |
| FDA | 28 | 3 |
| EMA | 4 | 3 |
| MHRA | 1 | 1 |
| European Union | 0 | 1 |
| ISPE | 2 | 1 |
| Health Canada | 1 | 0 |
| PMDA | 2 | 0 |
| NMPA | 0 | 1 |
Planned areas
Not built yet, so they have no map.
- Medical Devices: GxP - CSV & Data Integrity: Software validation and quality system rules for medical devices. Not built yet.
- Medical Devices: GxP - AI: AI and machine learning in medical devices. Not built yet.