ICH guideline
ICH M3(R2) Q&As (R2): Questions & Answers: Guidance on Nonclinical Safety Studies for the Conduct of Human…
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M3(R2) Q&As (R2) |
|---|---|
| Title | Questions & Answers: 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 complexity of the M3(R2) Guidance, its broader scope, and numerous changes in recommendations from the M3(R1) Guidance have generated questions that impact its successful implementation. To clarify the key issues of this document, the Steering Committee has endorsed the establishment of a M3(R2) Implementation… |
| File | M3(R2) Q&As (R2) Concept Paper |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M3(R2) Q&As (R2) Concept Paper 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.