Technical Guidelines on Clinical Development of Type-2 Diabetes Mellitus Drugs for Adults
Request Technical Guidelines on Clinical Development of Type-2 Diabetes Mellitus Drugs for Adults
  • 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
Document
Language Source Title Access
ZH Official 成人2型糖尿病药物临床研发技术指导原则 Download
Summary

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.