ICH guideline
ICH E21 EWG: Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials
ICH guideline · Efficacy Guidelines · Step 3
Key facts
| ICH code | E21 EWG |
|---|---|
| Title | Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 3 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in May 2022. Further to the ICH Management Committee’s endorsement of the E21 Concept Paper in June 2023 the E21 Guideline seeks to provide a globally accepted framework and best practices to enable inclusion and/or retention of pregnant and breast-feeding individuals in… |
| File | E21 Step 2 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E21 Step 2 Presentation 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.