The guidelines mainly apply to non-insulin single-API (active pharmaceutical ingredient) chemical drugs and therapeutic biological products for type 2 diabetes mellitus in adult patients, but can also be a reference for insulins or other new therapies. The guidelines do not involve the R&D of drugs for type 1 diabetes mellitus.
- Local Title:成人2型糖尿病药物临床研发技术指导原则
- Country/Region:Chinese Mainland
- Competent Authority: Center for Drug Evaluation (CDE)
- Type:Guideline
- Status:In force
- Release Date:2023-02-21
- Implementation Date:2023-02-21