ICH guideline
ICH S5(R3): Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human…
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S5(R3) |
|---|---|
| Title | Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Steering Committee in March 2015 and the ICH S5(R3) Guideline on Detection of Toxicity to Reproductions for Human Pharmaceuticals reached Step 4 of the ICH Process in February 2020. This third revision of the ICH S5 Guideline incorporates experience gained with the testing of… |
| File | S5(R3) Step 4 Audio Presentation |
| File type | PowerPoint |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- S5(R3) Step 4 Audio 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.