ICH guideline
ICH M7(R2) Q&As: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit…
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M7(R2) Q&As |
|---|---|
| Title | Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH M7(R2) Questions and Answers (Q&As) reached Step 4 of the ICH process on 24 May 2022. The M7(R2) Q&A document is intended to provide additional clarification and to promote convergence and improve harmonisation of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the… |
| File | M7(R2) Q&As Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M7(R2) Q&As Step 4 Presentation 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.