ICH guideline
ICH M14: General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies…
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M14 |
|---|---|
| Title | General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in in June 2021.The ICH M14 Guideline reached Step 4 of the ICH process on 04 September 2025.The M14 Guideline:Provides recommendations for generating real-world evidence (RWE) from real-world data (RWD) for regulatory submissions on post-marketing safety, acknowledging… |
| File | M14 Step 4 presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M14 Step 4 presentation Files published by ICH
- 1–9 FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.