ICH guideline
ICH E2E: Pharmacovigilance Planning
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E2E |
|---|---|
| Title | Pharmacovigilance Planning |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in November 2004. This Guideline is intended to aid in planning pharmacovigilance activities, especially in preparation for the early post-marketing period of a new drug (in this Guideline, the term "drug" denotes chemical entities, biotechnology-derived… |
| File | E2E Concept Paper |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- E2E Concept Paper 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.