Guidelines Tracker
The guidelines tracker monitors all relevant ICH, EMA, FDA, PMDA, and other agency guidance documents. Draft guidelines are tracked for comment period deadlines and final implementation dates. Linked products enable impact assessment when guidelines are updated.
| ID | Title | Agency | Category | Version | Status | Date | Linked Products |
|---|---|---|---|---|---|---|---|
| GL-001 | ICH E6(R3) Good Clinical Practice | ICH | GCP | R3 | Final | 2023-05-17 | 18 |
| GL-002 | ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management | ICH | CMC | 1.0 | Final | 2019-11-20 | 22 |
| GL-003 | EMA Guideline on Similar Biological Medicinal Products | EMA | Biologics | Rev.2 | Final | 2022-10-12 | 6 |
| GL-004 | FDA Guidance for Industry: S9 Nonclinical Evaluation for Anticancer Pharmaceuticals | FDA | Nonclinical | Q&A | Final | 2010-03-15 | 8 |
| GL-005 | ICH M4Q(R1) Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality | ICH | CTD | R1 | Final | 2002-09-12 | 30 |
| GL-006 | EMA Guideline on the Investigation of Bioequivalence | EMA | Bioequivalence | Rev.1 | Final | 2010-01-20 | 12 |
| GL-007 | FDA Guidance on Real-World Evidence Framework | FDA | RWE | Draft | Draft | 2025-02-14 | 5 |
| GL-008 | ICH Q13 Continuous Manufacturing of Drug Substances and Drug Products | ICH | Manufacturing | 1.0 | Final | 2022-11-16 | 3 |
| GL-009 | EMA Annex I: Summary of Product Characteristics — Template | EMA | Labeling | 5.0 | Final | 2024-01-15 | 20 |
| GL-010 | FDA 21 CFR Part 11: Electronic Records; Electronic Signatures | FDA | Compliance | Current | Final | 1997-08-20 | 30 |
| GL-011 | PMDA Guidance on Electronic Common Technical Document | PMDA | CTD | 3.0 | Final | 2024-03-01 | 8 |
| GL-012 | ICH E8(R1) General Considerations for Clinical Studies | ICH | Clinical | R1 | Final | 2021-10-12 | 25 |