ICH guideline
ICH S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S6(R1) |
|---|---|
| Title | Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in July 1997. This document covers the preclinical safety testing requirements for biotechnological products. It addresses the use of animal models of disease, determination of when genotoxicity assays and carcinogenicity studies should be performed, and the… |
| File | S6(R1) Training Material |
| File type | Video |
| File on ich.org | database.ich.org |
At a glance
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- S6(R1) Training Material Files published by ICH
- 1–9 FDA guidance documents based on this guideline
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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.