This Guidelines applies to supplemental applications (including those in the drug clinical trial period) reviewed and approved by the national drug regulatory authorities.
- Local Title:化学药品变更受理审查指南(试行)
- 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