ICH guideline
ICH S13 EWG: Nonclinical Safety Studies for Oligonucleotide-based Therapeutics
ICH guideline · Safety Guidelines
Key facts
| ICH code | S13 EWG |
|---|---|
| Title | Nonclinical Safety Studies for Oligonucleotide-based Therapeutics |
| Guideline series | Safety Guidelines |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in June 2023, and an Expert Working Group (EWG) has been established to develop a final Concept Paper. |
| File | S13 Work Plan |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S13 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.