ICH guideline
ICH S7A: Safety Pharmacology Studies for Human Pharmaceuticals
ICH guideline · Safety Guidelines · Step 5
Key facts
| ICH code | S7A |
|---|---|
| Title | Safety Pharmacology Studies for Human Pharmaceuticals |
| Guideline series | Safety Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was adopted under Step 4 in November 2000. This document provides a definition, general principles and recommendations for safety pharmacology studies. This Guideline generally applies to new chemical entities and biotechnology-derived products for human use. It can be applied to marketed… |
| File | S7A Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- S7A Step 4 Presentation 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.