期刊文献+
共找到1篇文章
< 1 >
每页显示 20 50 100
Criteria and regulatory considerations for the conditional approval of innovative antitumor drugs in China:from the perspective of clinical reviewers
1
作者 Limin Zou Yueli Qi +7 位作者 Yongling Jiang Ling Tang Yu Du Boyuan Zhao yanzhe sun Meiyi Xiang Jun Ma Zhimin Yang 《Cancer Communications》 SCIE 2023年第2期171-176,共6页
1 BACKGROUND Before the State Council of the People’s Republic of China issued the“Opinions on the Reform of the Examination and Approval System of Pharmaceutical and Medical Devices”[1],several problems existed in... 1 BACKGROUND Before the State Council of the People’s Republic of China issued the“Opinions on the Reform of the Examination and Approval System of Pharmaceutical and Medical Devices”[1],several problems existed in China’s drug evaluation and approval system.The long approval time and low efficiency of new drug marketing seriously affected the enthusiasm for drug innovation.To this end,the current“Drug Registration Regulation”(DRR)[2]was initiated by the National Medical Products Administration of China and officially implemented on July 1,2020.To encourage clinical value-oriented drug innovation,four expedited drug programs were first proposed,including breakthrough therapy drugs,conditional approval,priority review,and special approval procedures.For drugs listed in the expedited programs,the drug regulatory authorities and professional technical institutions should provide policy and technical support,prioritize the allocation of communication and review resources,and thereafter shorten the review time as much as possible. 展开更多
关键词 APPROVAL DRUGS BREAKTHROUGH
原文传递
上一页 1 下一页 到第
使用帮助 返回顶部