ICH guideline
ICH E2C(R2): Periodic Benefit-Risk Evaluation Report
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E2C(R2) |
|---|---|
| Title | Periodic Benefit-Risk Evaluation Report |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 1996. This document gives guidance on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed. The Guideline is intended to ensure that the worldwide safety experience… |
| File | E2C(R2) Training Material |
| File type | Video |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- E2C(R2) Training Material 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.