ICH guideline
ICH M7 Sub-group: Risk Assessment and Control of Nitrosamine Impurities
ICH guideline · Multidisciplinary Guidelines · Step 1
Key facts
| ICH code | M7 Sub-group |
|---|---|
| Title | Risk Assessment and Control of Nitrosamine Impurities |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 1 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in June 2024 and the M7 Sub-group has been established to develop an addendum to the M7 Guideline on Assessment and Control of DNA Reactive (mutagenic) Impurities to address safety assessment and establishment of appropriate controls for nitrosamine impurities. |
| File | M7 Sub-group Work Plan |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M7 Sub-group 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.