ICH guideline
ICH M7(R2): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit…
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M7(R2) |
|---|---|
| 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) Guideline reached Step 4 of the ICH process on 3 April 2023. The M7(R2) Guideline is intended to provide guidance for new drug substances and products during their clinical development and subsequent applications for marketing. It also applies to post-approval submissions of marketed products, and to… |
| File | M7(R1) Training Material |
| File type | Video |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- M7(R1) Training Material 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.