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武汉市食品药品监督管理局 关于支持食品药品产业创新发展的若干措施

2017-09-05 07:17:01   中国青年网

为支持我市食品药品(含医疗器械、化妆品,下同)产业创新发展,深入推进“放管服”改革,引领企业主动适应经济发展新常态,充分释放市场活力和发展动能,促进食品药品监管部门以严格的专业监管和优质的高效服务维护食品药品产业健康发展,让人民群众不断增强获得感和幸福感。现提出关于支持食品药品产业创新发展的若干措施:

一、搭建创新产品申报政策咨询和技术服务平台

为我市食品药品生产企业优化创新产品检验检测流程,积极参与企业产品标准制定。鼓励药品生产企业积极开展仿制药质量和疗效的一致性评价工作,市药品医疗器械检验所为我市药品生产企业免费提供仿制药的复核检验,并联合国内外高校、科研院所和药品生产企业,建立仿制药一致性评价技术与标准研究平台。

二、进一步下放行政审批事项

市局负责的 14类 58项(不含省局委托的5类18项)行政审批,做到应下尽下,能放尽放,力争在2017年10月前下放50%以上;以许可申请人需求为导向,不断提升“马上办、网上办、一次办” 联动服务能力,向社会公开《“马上办、网上办、一次办”事项清单》,主动接受社会监督。

三、进一步放宽行政审批条件,拓展“绿色通道”促进宽进快审

对食品生产企业QS证换发SC证、许可证延续及迁址、新增品种以外的变更事项,不再进行现场核查;保健食品生产企业同时生产普通食品,中药生产企业同时生产保健食品的,其生产工艺和质量安全符合相关要求的,可以共用生产线。从事食品药品生产的同一企业集团内部或者同一法人代表的不同企业位于同一注册地址的,在具备检验资质、检验条件的前提下可以共用检验资源。

四、进一步改进行政审批方式,积极探索“多证合一”

对同一申请人要求在同一地点办理药品经营(零售)、食品(含特殊食品)销售、医疗器械经营等多个许可或者备案事项的,合并核发一个许可证;将药品零售环节的经营质量管理规范认证与许可证 “合二为一”并在许可证(副本)上注明,将药品经营质量管理规范认证纳入日常监管项目,不再单独组织药品零售环节GSP认证。持有许可证的小餐饮经营户可以不经许可销售依法购进的少量预包装食品。

五、扶持医疗机构特色制剂创新发展,放行非药用单方中药材及其加工品销售

对于本市医疗机构依法获得制剂文号的特色制剂,可申请在本市医疗机构之间调剂使用,促进医院临床用药研发,实现资源共享;零售药店可以不增加中药饮片的经营范围而销售药食同源的以及滋补类的单方中药材及其加工品。

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