ICH guideline
ICH S1A: Need for Carcinogenicity Studies of Pharmaceuticals
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S1A |
|---|---|
| Title | Need for Carcinogenicity Studies of Pharmaceuticals |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 1995. This document provides a consistent definition of the circumstances under which it is necessary to undertake carcinogenicity studies on new drugs. These recommendations take into account the known risk factors as well as the intended indications… |
| File | S1A Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- S1A Guideline 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.