ICH guideline
ICH M7(R3) Maintenance EWG/IWG: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit…
ICH guideline · Multidisciplinary Guidelines
Key facts
| ICH code | M7(R3) Maintenance EWG/IWG |
|---|---|
| Title | Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk |
| Guideline series | Multidisciplinary Guidelines |
| ICH summary (excerpt) | The ICH M7 Guideline was finalised under Step 4 in June 2014, with a M7(R2) Guideline and Addendum reaching Step 4 of the ICH process in April 2023 and M7(R2) Q&A reaching Step 4 in May 2022. Maintenance ProcessA Maintenance process for the M7 Guideline was set-up to enable the revision and inclusion of new drug… |
| File | Maintenance Procedure for Q3C, Q3D and M7 |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Maintenance Procedure for Q3C, Q3D and M7 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.