ICH guideline
ICH S9 Q&As: Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S9 Q&As |
|---|---|
| Title | Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The document was adopted under Step 4 in June 2018. Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the S9 Guideline on nonclinical evaluation for anticancer pharmaceuticals have resulted in the need for some clarification. The Questions and Answers… |
| File | S9 Q&As Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S9 Q&As Step 4 Presentation 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.