ICH guideline
ICH Q5A(R2): Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or…
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q5A(R2) |
|---|---|
| Title | Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Q5A Guideline reached Step 4 of the ICH process on 1 November 2023.The revision retains key principles of the original Guideline and provides additional recommendations on the established and complementary approaches to control the potential viral contamination of biotechnology products and describes the… |
| File | Q5A(R2) Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q5A(R2) 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.