Breakthrough Therapy Designation (BTD) is one of the four expedited programs for drug registration in China. The document introduces the qualification for applying for BTD and the review process of the applications.
- Local Title:突破性治疗药物审评工作程序(试行)
- Country/Region:Chinese Mainland
- Competent Authority: National Medical Products Administration (NMPA)
- Type:Regulation
- Status:In force
- Release Date:2020-07-08
- Implementation Date:2020-07-08