ICH guideline
ICH Q4B(R1): Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q4B(R1) |
|---|---|
| Title | Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in June 2024. This document describes a process for the evaluation and recommendation by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions… |
| File | Maintenance of Q4B |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- Maintenance of Q4B Files published by ICH
- None FDA guidance documents based on this guideline
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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.