The Guidelines is used to guide the hazard assessment, classification, and limit establishment of genotoxic impurities in drugs, so as to control the potential carcinogenic risk of genotoxic impurities in drugs. The Guidelines provides a reference for formulating and revising drug standards and the reevaluating the safety of the drugs approved with marketing authorization.
- Local Title:9306 遗传毒性杂质控制指导原则
- Country/Region:Chinese Mainland
- Competent Authority: Chinese Pharmacopoeia Commission
- Type:Guideline
- Status:In force
- Release Date:2020-07-02
- Implementation Date:2020-12-30