ICH guideline
ICH S5(R4): Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human…
ICH guideline · Safety Guidelines
Key facts
| ICH code | S5(R4) |
|---|---|
| Title | Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals |
| Guideline series | Safety Guidelines |
| ICH summary (excerpt) | In March 2019, the ICH Management Committee approved the establishment of a maintenance procedure for the S5 Guideline on Detection of Toxicity to Reproductions for Human Pharmaceuticals. The maintenance procedure (attached on this accordion) aimed to facilitate proper implementation of novel testing paradigms and… |
| File | Maintenance Procedure for S5 Annexes 1 & 2 |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Maintenance Procedure for S5 Annexes 1 & 2 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.