Comparison and reflection on the policies, regulations and implementation of conditional drug approval between China and other countries/regions
王心怡 1孙加琳 1全香花 1姜曼 1李静 1沈素
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作者信息
1. 青岛大学附属医院药学部，青岛 266000
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摘要
药品附条件批准是指具有突出治疗价值的临床急需药品在未完成完整临床试验的情况下，通过"先批准后验证"的形式加快批准上市。从20世纪90年代起，美国、加拿大、欧盟、日本、澳大利亚和英国等先后实施药品附条件上市审批。2017年10月，我国开始批准药品附条件上市申请。本文对我国与其他国家/地区的药品附条件上市前条件和要求、上市后监测和监管的情况进行了比较，根据对比结果归纳并探讨了我国药品附条件审批制度可能的优化方向。 Drug conditional approval refers to the accelerated approval and marketing of clinically urgently needed drugs with outstanding therapeutic value through the form of "approval first, verification later" before completing complete clinical trials. Since the 1990s, the United States, Canada, the European Union, Japan, Australia, and the United Kingdom have successively implemented drug conditional approval for marketing. In 2017, the application for conditional approval of drugs was implemented in China. In this paper, the pre-market conditions and requirements, post-market monitoring and supervision of drugs in China are compared with other countries/regions. Based on the comparison results, the possible optimization directions of China′s drug conditional approval system are summarized and explored.
Abstract
Drug conditional approval refers to the accelerated approval and marketing of clinically urgently needed drugs with outstanding therapeutic value through the form of "approval first, verification later" before completing complete clinical trials. Since the 1990s, the United States, Canada, the European Union, Japan, Australia, and the United Kingdom have successively implemented drug conditional approval for marketing. In 2017, the application for conditional approval of drugs was implemented in China. In this paper, the pre-market conditions and requirements, post-market monitoring and supervision of drugs in China are compared with other countries/regions. Based on the comparison results, the possible optimization directions of China′s drug conditional approval system are summarized and explored.
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