This Guidelines applies to chemicals drugs, preventive biological products, and therapeutic biological products. It specifies the clinical changes after drug approval in China and classifies the changes according to the degree of change and possible effect on the safety and effectiveness in the clinical use of the drug, as well as the degree of risk. The Guidelines also details the submission procedures and technical requirements for different categories of changes.
- Local Title:已上市化学药品和生物制品临床变更技术指导原则
- Country/Region:Chinese Mainland
- Competent Authority: Center for Drug Evaluation (CDE)
- Type:Guideline
- Status:In force
- Release Date:2021-02-10
- Implementation Date:2021-02-10