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外媒:中国药品审批新政落地 提速审批获好评

2017-10-11 16:21:53   

原标题:外媒:中国药品审批新政落地 接受境外数据提速审批获好评

外媒称,中国将允许在新药审批中使用境外临床试验数据,此举很可能使跨国公司能够更快地把产品带到世界第二大医药市场。

据英国《金融时报》网站10月9日报道,中国的药品审批时间可能比欧洲和美国长7年,因为它要求在海外临床试验进入高级阶段后才能在中国开始试验。据咨询公司昆泰中国公司说,去年中国药品市场的销售额为1170亿美元。

中办国办发文称,今后,在某些情况下将允许制药企业使用境外临床试验数据,从而不用在中国开展临床试验。

报道称,此举被认为是跨国制药企业的福利。这些企业希望把更多创新药卖给越来越富裕、但正在与快速增加的慢性病(比如癌症)负担作斗争的中国人。

研究团体科睿唯安公司的李尹(音)说:“这对海外药企的创新药在中国获得批准来说是个积极因素。等待审批的药品长队有望更快解决。”

国家食品药品监督管理总局官员王立丰说,使用境外临床试验数据的一个条件是要显示试验结果适用于东方人。分析人士称,尚未公布满足这一要求的细节,但这很可能意味着试验要包含一定数量的亚洲人或华人。

国家食品药品监督管理总局副局长吴浈9日说,此前的审批制度意味着过去15年约有100种新药在中国获得批准,是发达国家同期获批新药的三分之一。

报道认为,从药物获得中国批准到药物实际进入中国市场,海外企业仍然可能经历漫长的过程。

例如,2016年7月,葛兰素史克公司成为首家获得批准在中国出售人乳头状瘤病毒疫苗的企业,但只是在13个月后,该药物才进入中国市场——到了那时,与之竞争的美国默克公司的一种类似产品也获批了。

9日内地股市的药业股飙升,因为市场预计它们也将受益于这些规定。这些规定是推动制药业创新的整体激励计划的一部分。

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