ICH guideline
ICH Q6(R1) EWG: Revision of the Specifications Guidelines
ICH guideline · Quality Guidelines
Key facts
| ICH code | Q6(R1) EWG |
|---|---|
| Title | Revision of the Specifications Guidelines |
| Guideline series | Quality Guidelines |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in June 2021. Further to the ICH Management Committee’s endorsement of the Q6(R1) Concept Paper in July 2024, the Q6(R1) Guideline aims to update and modernise simultaneously the ICH Q6A and Q6B guidelines by promoting consistency between ICH Q6A and Q6B and establish general… |
| File | Q6(R1) Work Plan |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Q6(R1) 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.