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药品审批新政落地 中国药企创新春天来了

2017-10-11 10:32:57   

药品审批新政落地

我国药企创新春天来了

缺医少药是中国老百姓面临的严峻事实。以抗癌新药为例,中国患者往往需要等待超过5年,才能用上国外新疗法。如今,这一局面将会得到有效扭转。

中国医药行业迎来重大利好政策。10月8日,中共中央办公厅和国务院办公厅联合印发《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》(以下简称《意见》)。这是继2015年8月《国务院关于改革药品医疗器械审评审批制度的意见》之后,又一个深化药品医疗器械审评审批制度改革的纲领性文件,对我国医药产业创新发展具有里程碑意义。

“作为医药创新企业我们倍感鼓舞,庆幸赶上了中国医药创新最好的时代。”贝达药业股份有限公司董事长兼CEO丁列明在接受科技日报记者采访时说。

丁列明表示,《意见》大力推进药品监管制度改革,有望进一步加快新药上市流程,满足中国广大老百姓的用药需求。

临床试验

机构资格由认定改为备案

“《意见》的核心就是鼓励创新,着力点在于解决公众的用药问题,让公众能用得上新药,用得上好药,当医生在给患者治病的过程当中能够有更多的选择。”9日,国家食品药品监督管理总局就《意见》相关情况举行发布会,该局副局长吴浈在会上说。

长期以来,药物审批的滞缓冗长,已很大程度制约药物创新,业界一直呼吁改革。

对此,国家食品药品监督管理总局药品、化妆品注册司司长王立丰表示,临床试验机构的资源相对紧缺,是制约我们药品创新发展的一个深层次问题。

“此次改革第一项就是将临床试验机构资格认定改为备案制,这是我们临床试验改革的一项重要内容。”王立丰说,大家都知道,药物研发最重要的一个环节就是临床试验,耗时时间长,投入成本高。当前,我国二级以上的医疗机构已经超过1万家,三级以上的医疗机构有2000多家,但是现在能够做药物临床试验的机构通过认定的只有600多家,特别是能够承担Ⅰ期临床试验的机构仅有100多家,某种程度上成为医药创新的瓶颈。

王立丰认为,目前临床试验机构的认定不能满足创新的需求,特别是现在临床机构还承担着大量的医疗任务,所以在临床机构里面如果能够分割出一些来承担药物临床试验,就显得尤为重要。临床试验机构由认定改成备案,这样可以减少环节,提高效率。

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