ICH guideline
ICH E19: A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or…
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E19 |
|---|---|
| Title | A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in September 2022. This Guideline is intended to provide internationally harmonised guidance on the use of selective safety data collection - by tailoring the method of safety data collection, it may be possible to carry out clinical trials with greater… |
| File | E19 Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E19 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.