安徽多措并举推动药械监管全过程改革|疯狂做受XXXX国产
中新网合肥11月17日电 (记者 张强)安徽省药品监督管理局局长马旭升17日称,日前印发的《安徽省全面深化药品医疗器械监管改革促进医药产业高质量发展若干措施》(下称《若干措施》),将深化安徽药械监管全过程改革,推动药械创新,加快培育发展新质生产力。
《若干措施》共提出了大力支持药品医疗器械研发创新、全力支持中药传承创新发展等5个方面21条具体改革举措。
《若干措施》提出,安徽将加强药械研发跟踪服务,对安徽省内在研创新药械实行“提前介入、一企一策、全程指导、研审联动”。
同时,提升中药饮片炮制水平,推动具有安徽特色的“徽派中药炮制技术体系”研究和传承;促进中药配方颗粒发展,支持中成药生产企业、中药饮片生产企业通过兼并、重组等方式成为具备中药配方颗粒完整生产能力的法人企业。
根据《若干措施》,在提高药品医疗器械审评审批质效方面,安徽将加强审评审批能力建设,全面提升职业化专业化药品检查员队伍使用和管理效率;完善审批前置服务,对重点园区、重点项目、重大创新产品实施跟踪服务机制;持续优化审评审批流程,深化“高效办成一件事”首创性差异化改革;促进临床急需药械加快上市,实行研检审联动,优先检验检测、注册核查、审评审批。
在提升医药产业合规水平方面,《若干措施》提出,安徽要推动医药产业集聚发展,支持在医药产业有先发优势和产业基础的市、县规划建设高标准特色产业园;提升医药流通新业态监管质效,支持药品流通企业高质量发展;加强医药产业开放合作,促进创新药械联合科研攻关、成果转化和产业协作。(完)
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