ICH guideline
ICH S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for…
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S2(R1) |
|---|---|
| Title | Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 2011. It replaces and combines the ICH S2A and S2B Guidelines. The S2A Guideline on Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals was finalised under Step 4 in July 1995. This document provided specific guidance… |
| File | S2(R1) Step 4 Presentation (PPT) |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S2(R1) Step 4 Presentation (PPT) 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.