The pharma regulatory map at a glance
| Lifecycle stage | Japan | United States | European Union | Global |
|---|---|---|---|---|
| Market access law | PMD Act | FD&C Act and 21 CFR | EudraLex Volume 1 | — |
| Development and quality design | PMDA guidelines | FDA guidance | EMA scientific guidelines | ICH Q8, Q9, Q10, Q12 |
| Clinical trials | PMD Act and GCP ordinance | FDA regulations and guidance | CTR 536/2014, EudraLex Volume 10 | ICH guidelines |
| Manufacturing (GMP) | GMP, GQP, GVP ordinances | 21 CFR 210, 211 | EU GMP and Annexes 1, 11, 15 | PIC/S PE 009, ICH Q7 |
| Electronic records | — | 21 CFR Part 11 and 2024 Q&A guidance | EU GMP Annex 11 and Chapter 4 | — |
| Quality standards | Japanese Pharmacopoeia | USP (not covered in this series) | Ph. Eur. (not covered in this series) | — |
| Product information and safety | Package inserts and RMPs, GVP | FDA labeling rules | EMA GVP guidance | — |
| Inspection and enforcement | PMDA and prefectural inspections | Form 483, warning letters | EudraGMDP | PIC/S cooperation |
What changed for pharma in 2025 and 2026
| Date | Change | Region |
|---|---|---|
| 31 Jan 2025 | CTR transition ends; all ongoing EU trials under CTR and CTIS | EU |
| Jul–Oct 2025 | Consultation on revised Chapter 4, Annex 11, and new Annex 22 (AI) | EU |
| 14 Jan 2026 | EMA and FDA publish 10 guiding principles of good AI practice in drug development | EU and US |
| Apr 2026 | JP19 notified; errata June and September 2026 | Japan |
| 15 Jul 2026 | Veterinary GMP leaves EudraLex Volume 4 | EU |
| 24 Sep 2026 | PIC/S PE 009-18 in force (revised Annex 19) | Global |
| Q4 2026 (target) | Final texts for Annex 11, Chapter 4, Annex 22, Annex 15, Chapter 1 | EU |
| Nov 2026 (target) | ICH Q1 consolidated stability guideline Step 4 | Global |
The big theme: AI is moving into GMP rules. The EU’s draft Annex 22 would set requirements for AI and machine learning in manufacturing, EMA and FDA have joint AI principles, and Annex 11 is being rewritten for modern computerized systems. Pharma teams building AI tools now face two questions: whether they may use a source in AI, and whether their own AI use meets emerging GMP expectations.
AI use terms for pharma sources
| Source | AI and RAG use |
|---|---|
| FDA regulations, guidance, 483 summaries, warning letters | Public domain unless noted; individual 483s need privacy review |
| EudraLex and EU GMP | CC BY 4.0 with attribution; keep drafts separate |
| EMA guidelines | Reuse allowed with EMA acknowledged in each copy |
| EudraGMDP | Check required: no bulk terms stated |
| PMDA guidelines | PDL1.0, but crawling and bulk download prohibited |
| Package inserts and RMPs | Copyright of marketing authorization holders |
| ICH guidelines | Use and adapt with ICH copyright acknowledged and changes labeled |
| PIC/S PE 009 | Terms not confirmed on the pages we opened; check before full-text use |
Building a pharma knowledge base
- Organize by lifecycle stage and region, using the map above.
- Tag every file as law, guidance, draft, or database.
- Link ICH texts to their regional implementations.
- Keep EU GMP drafts (Annex 11, Annex 22) in a separate collection until final texts are adopted.
- Version-track the pharmacopoeias and PIC/S (JP19 errata, PE 009-18).
- Review your own AI use against draft Annex 22 and the EMA/FDA AI principles.
How AskDona helps
AskDona checks SOPs, validation records, batch documentation, and dossier sections against 21 CFR 211, EU GMP, and Japanese GMP in one pass, with each requirement cited to its region, layer, and version.
Run a sample three-region GMP check
AskDona shows the evidence; your quality team decides.
Editor’s note. This article is general information, not legal advice. Status and terms summarize the detailed articles linked above, each checked against official or primary pages by October 26, 2026. USP and Ph. Eur. were not part of the source list and are not covered.
FAQ
Is EU GMP Annex 22 on AI in force? No. It was a 2025 draft; a final text is targeted for Q4 2026.
What is the current PIC/S GMP guide? PE 009-18, in force since 24 September 2026.
Can I put ICH guidelines into an AI tool? Yes, with ICH copyright acknowledged and changes labeled. The logo and third-party content are excluded.
Are FDA warning letters final findings? No. They are informal and advisory, and matters may have changed since issue.
References
All pages opened and checked by October 26, 2026. Each linked article lists its own primary sources.
| Source | What it supports |
|---|---|
| EMA: Clinical Trials Regulation | CTR transition dates |
| Commission consultation: Chapter 4, Annex 11, Annex 22 | Consultation dates and scope |
| EMA: Artificial intelligence | EMA/FDA AI principles |
| European Commission: EudraLex Volume 4 | Annex status; veterinary GMP change |
| MFLRC: EU GMP guide revisions 2026–2028 | Q4 2026 targets |
| PIC/S news | PE 009-18 in force |
| ICH Q1 work plan (PDF) | Q1 Step 4 target |
| ICH Q9(R1) (PDF) | ICH copyright terms |
| EMA legal notice | EMA reuse terms |
| FDA Website Policies | Public domain unless noted |