ICH guideline
ICH Q5E Annex EWG: Comparability of Advanced Therapy Medicinal Products (ATMPs) Subject to Changes in Their…
ICH guideline · Quality Guidelines · Step 1
Key facts
| ICH code | Q5E Annex EWG |
|---|---|
| Title | Comparability of Advanced Therapy Medicinal Products (ATMPs) Subject to Changes in Their Manufacturing Process |
| Guideline series | Quality Guidelines |
| ICH step | Step 1 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in April 2025, and the Q5E Annex Working Group has been established to develop a final Concept Paper. |
| File | Q5E Annex Work Plan |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q5E Annex Work Plan 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.