ICH guideline
ICH E2B(R3) Q&As: Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety…
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E2B(R3) Q&As |
|---|---|
| Title | Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | In July 2013, the ICH Steering Committee endorsed the establishment of the IWG on E2B(R3) to assist with the implementation of the E2B(R3) Implementation Guide (published in July 2013) and help facilitate transition from E2B(R2) to E2B(R3). Included in its tasks is support for the use of constrained ISO IDMP… |
| File | E2B(R3) Concept Paper |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E2B(R3) Concept Paper Files published by ICH
- None 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.