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中国仿制药正步入国际主流市场 一致性评价成闯关关键

2016-12-23 10:33:02   

近日,由国家食品药品监督管理总局和广西壮族自治区人民政府共同主办的第四届中国—东盟药品合作发展高峰论坛暨西太平洋地区草药协调论坛在南宁举办。本届论坛以“提升仿制药质量”为主题,共同探讨药品监管的国际发展之路,谋求打造中国药品监管部门与东盟以及一带一路国家的监管合作平台。

作为全球重要的医药市场,中国是最大的仿制药生产国,仿制药成为拉动全球药品销售增长的主要力量。但是,目前我国仿制药发展面临着“一致性评价”、质量参差不齐等多重难题。与会代表认为,应不断提高药品科研能力,全面提高仿制药质量,为我国药品进军国际市场打下更加坚实的基础。

中国仿制药逐渐得到国际认可

国家食品药品监督管理总局副局长吴浈称,经过长期努力,中国仿制药产业逐渐得到国际认可,目前已有超过300个原料药和40个制剂获准在美国上市销售,25个原料药和17个制剂获得世界卫生组织预认证,中国制造的仿制药正在逐渐步入国际主流医药市场。

“仿制药不是原研药的山寨产品,而是原研药的复制品,与原研药在规格、剂型、用法、用量、质量可控性和疗效方面一模一样,可以完全替代原研药。”吴浈说,世界各国都鼓励和发展仿制药,通过有效、安全、廉价的仿制药,降低药品价格,提高药物可及性。

与会代表一致认为,与原研药相比,仿制药的研发时间大大缩短,经济投入大大降低,因此价格也低于原研药。仿制药具有降低医疗支出、提升医疗服务水平、提高药品可及性和可负担性等重要的经济和社会效益,为解决患者因经济困难而无法用药治疗的窘迫局面提供了新的途径。

中国制药产业基本处于“仿制为主、仿创结合”的阶段。早在2007年,在修订《药品注册管理办法》时,我国药品监管部门就要求,凡是国内市场有原研药的,仿制药必须与原研药进行对比,否则不予批准。目前,我国可生产全球2000多种化学原料药中的1600多种,化学药品制剂4500多个品种,疫苗年产量超过10亿个剂量单位。

国家食品药品监督管理总局数据统计显示,在制药工业领域,我国至2015年共有制药企业5065家,流通销售企业46.6万家,医药工业总产值2.8万亿元。吴浈说,中国拥有强大而齐全的生产能力,在保证本国人民用药需求的同时,也可以为东盟等国家人民的健康提供支持。

一致性评价成仿制药发展瓶颈

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