ICH guideline
ICH S12: Nonclinical Biodistribution Considerations for Gene Therapy Products
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S12 |
|---|---|
| Title | Nonclinical Biodistribution Considerations for Gene Therapy Products |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in June 2019. The ICH S12 Guideline reached Step 4 of the ICH process on 14 March 2023. The ICH S12 Guideline: Provides harmonised recommendations for the conduct of nonclinical biodistribution (BD) studies in the development of gene therapy (GT) products; Includes… |
| File | S12 Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S12 Step 4 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.