ICH guideline
ICH E23 EWG: Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision…
ICH guideline · Efficacy Guidelines
Key facts
| ICH code | E23 EWG |
|---|---|
| Title | Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a Focus on Effectiveness of Medicines |
| Guideline series | Efficacy Guidelines |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in May 2025, and the E23 Working Group has been established to develop a final Concept Paper. |
| File | E23 Work Plan |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E23 Work Plan Files published by ICH
- None 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.