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肺癌患者国内求医被“判死刑” 赴美治愈可跑步

2016-08-20 04:02:08   中国新闻周刊

幸运的是,张天银符合临床试验的入组条件,进入试验组后,他一直接受治疗,如今已有六七年,他对效果很满意。现在,他不觉得自己是在接受试验,而把这个过程当成一个完整的治疗方案。

审批积压1.7万件

中国新药研发的落后已是不争的事实。根据美国临床试验注册中心的数据,截至2015年10月,全球共有201149项临床试验登记注册,其中有48.53%在美国进行,在中国开展的药物临床试验仅占 9.75%。

以抗肺癌药为例,美国已经开始了第IV代靶向药物的临床试验,而中国还停留在第I代靶向药上。这意味着,一旦患者产生抗药性,在中国治疗的患者将没有其他药品可供选择。

中国新药审批的第一步是批准开展临床试验。2007年发布的《药品注册管理办法》对每个审批环节都做了时间限定,其中,新药临床试验审批的时间不得超过90天,但实际上,来自国家食品药品监督管理总局(以下简称食药监局)的数据显示,2014年,中国1.1类新药、3.1类新药及6类新药申报临床试验的平均审评时间为14个月、28个月和28个月。

而在美国,申报者向美国食品药品监督管理局(以下简称FDA)提出新药临床试验申请后,如果30天内没有收到FDA作出暂停临床研究的决定,便意味着通过审批。

相对于美国“宽进严出”的审批制度,中国刚好相反。申报者必须经过国家和省级药监管理部门的两级审批,获得批件后,才可以进行临床试验。

中国临床试验对申请者的药学研究资料要求更为详细,所有材料要在Ⅰ期临床试验前提交,且在4个月内一次性补齐所有材料。但事实上,对于新药的临床试验而言,许多研究数据难以在Ⅰ期临床前提交。在美国,这些资料都可以随着研究计划的开展而逐步提交。

为了提高FDA的工作效率和药品审评审批质量,美国早在1992年颁布的《处方药申报者付费法案》中便要求:新药申报者可以向FDA交纳一定的申请费、处方药生产场地年费等,并要求FDA必须在限定的时间内,完成审评、审批工作。这项收入可以让FDA聘请更多不同领域的专家和审评人员、更新信息技术设施,极大地缩短审批时间。

拥有9300多名雇员的FDA,是美国联邦政府雇员最多的政府部门之一。但区别于美国的半商业化模式。公开数据显示,2014年,中国食药监局机关行政编制为345人,其中稽查专员仅有10人。虽然食药监局在受理药品注册申请时收取一定的费用,但这些费用全部上缴国库,并不能用于优化审评资源。

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