Criteria and regulatory considerations for the conditional approval of innovative antitumor drugs in China: from the perspective of clinical reviewers

[摘要] Before the State Council of the People’s Republic of Chinaissued the “Opinions on the Reform of the Examination and Approval System of Pharmaceutical and MedicalDevices” [1], several problems existed in China’s drug evaluation and approval system. The long approval time andlow efficiency of new drug marketing seriously affectedthe enthusiasm for drug innovation. To this end, thecurrent “Drug Registration Regulation” (DRR) [2] was initiated by the National Medical Products Administrationof China and officially implemented on July 1, 2020. Toencourage clinical value-oriented drug innovation, fourexpedited drug programs were first proposed, includingbreakthrough therapy drugs, conditional approval, priorityreview, and special approval procedures. For drugs listedin the expedited programs, the drug regulatory authorities and professional technical institutions should providepolicy and technical support, prioritize the allocationof communication and review resources, and thereaftershorten the review time as much as possible.

[学科分类] 社会科学、人文和艺术（综合）