ICH guideline
ICH M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and…
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M3(R2) |
|---|---|
| Title | Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The recommendations of this revised Guidance further harmonise the nonclinical safety studies to support the various stages of clinical development among the ICH regions. The present Guidance represents the consensus that exists regarding the type and duration of nonclinical safety studies and their timing to support… |
| File | M3(R2) Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M3(R2) 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.