The National Medical Products Administration ("NMPA") has recently promulgated the Working Procedures for the Evaluation of Breakthrough Therapy Designation Drugs (for Trial Implementation) (the "Working Procedures"), the Working Procedures for the Evaluation and Approval of the Applications for Marketing-oriented Conditional Approval of Drugs (for Trial Implementation) and the Working Procedures for the Priority Evaluation and Approval of Marketing Authorization (for Trial Implementation), with effect from the date of promulgation.
The Working Procedures contain three aspects of content, namely the scope and conditions of application, working procedures, and working requirements. The Working Procedures clarify that, an applicant shall satisfy two conditions including "being used for prevention and treatment of seriously life-threatening diseases or those seriously affecting the quality of life" when applying for procedures for breakthrough therapy designation ("BTD") drugs during clinical trials. Meanwhile, the Center for Drug Evaluation ("CDE") will terminate the procedures for BTD drugs if finding any of the three circumstances including "new clinical trial data no longer shows obvious clinical advantages compared with existing treatment measures". The Working Procedures also propose that, for the variety incorporated into the procedures for BTD drugs, the applicant, eligible upon assessment, may apply for conditional approval and priority in evaluation and approval when applying for marketing authorization.