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  4月21日电据“海关发布”微信公众号21日消息,国家药监局、海关总署近日发布关于允许进口牛黄试点用于中成药生产有关事项的公告。公告称,对于来自不存在疯牛病疫情禁令国家(地区),且符合我国海关检疫要求和药品质量检验要求的牛黄,允许其试点用于中成药生产。

  公告全文如下:

国家药监局海关总署关于允许进口牛黄试点用于中成药生产有关事项的公告

(2025年第25号)

  为进一步贯彻落实《中共中央国务院关于促进中医药传承创新发展的意见》《国务院办公厅关于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的意见》,扩大境外优质药材资源进口,满足临床用药需求,服务中医药产业高质量发展,依据《中华人民共和国药品管理法》《进口药材管理办法》《进出境中药材检疫监督管理办法》等有关规定,现将允许进口牛黄试点用于中成药生产的有关事项公告如下。

  一、开展牛黄进口使用试点

  对于来自不存在疯牛病疫情禁令国家(地区),且符合我国海关检疫要求和药品质量检验要求的牛黄,允许其试点用于中成药生产。试点时限设定为自本公告发布之日起2年,到期后根据试点工作情况,逐步在全国范围内推进牛黄进口使用相关工作。

  (一)试点区域。为稳妥推进牛黄进口用于中成药生产相关试点工作,结合区域改革发展需求,确定如下试点区域:北京、天津、河北、上海、浙江、江西、山东、湖南、广东、四川、福建、广西等12省(自治区、直辖市)。

  (二)牛黄进口申请人的要求。牛黄进口申请人应当为试点区域内处方含牛黄的中成药品种的药品上市许可持有人。进口的牛黄除进口申请人自用于相关中成药的生产外,同一集团公司试点区域内的控股企业也可使用已进口的牛黄。集团内部应当明确界定各企业在牛黄进口及使用过程中的责任和义务,确保进口的牛黄仅用于集团内部指定企业相关中成药的生产,不得对外销售。

  (三)进口牛黄存放加工要求。进口牛黄应当符合《进出境中药材检疫监督管理办法》有关要求,并在进境动植物检疫许可证列明的企业存放和加工。

  二、牛黄进口通关要求

  (一)进口牛黄应当来自海关总署网站公布的《获得我国检疫准入动植物源性药材种类及输出国家地区名录》中的国家(地区),并来自经海关总署注册登记的境外牛黄生产企业。

  (二)牛黄进口前应当依法办理进境动植物检疫审批手续,取得《中华人民共和国进境动植物检疫许可证》。

  (三)牛黄的进口(含从境外进入海关特殊监管区域)应当从试点区域相应的药品口岸通关,海关负责在境外进入海关特殊监管区域或者保税监管场所进口检疫。试点区域相应的口岸药品监督管理部门负责出具通关单,口岸药品检验机构或者指定的药品检验机构负责进口牛黄的口岸检验,海关在海关特殊监管区域或者保税监管场所进入国内环节验核通关单。企业不得在海关特殊监管区域内开展牛黄制剂的生产加工。

  (四)首次进口牛黄,申请人应当按照《进口药材管理办法》规定向试点区域省级药品监督管理部门报送相关资料,详细说明境外牛黄产地加工的情况,并取得《进口药材批件》。

  (五)进口牛黄的抽样、检验和通关,由各口岸相对应的口岸药品检验机构或者指定的药品检验机构和口岸药品监督管理部门承担。河北省的牛黄进口检验由北京市药品检验研究院承担,由北京市药品监督管理局出具通关单;江西省的牛黄进口检验由上海市食品药品检验研究院承担,由上海市药品监督管理局出具通关单。河北、江西省药品监督管理局负责本辖区牛黄首次进口申请的审批和进口通关后的监管。

  三、药品上市许可持有人相关要求

  (一)使用进口牛黄生产中成药的药品上市许可持有人,应当将药品生产质量管理体系向境外牛黄产地加工(包括但不限于牛黄摘取、阴干、储存等)环节延伸,从源头加强牛黄质量控制,确保牛黄质量安全。

  (二)药品上市许可持有人应当建立进口牛黄的追溯体系,覆盖产地加工、进口、运输、储存、投料等环节,应当制定相应管理制度和存放加工操作规程,投料用于中成药生产的进口牛黄应当专库(或专柜)储存、专人管理、专账记录。

  (三)使用进口牛黄生产中成药的生产企业应当设置单独的生产设备,不得与其他品种共线生产。

  四、监督管理要求

  相关省级药品监督管理部门要加强对牛黄进口及使用进口牛黄生产中成药的监管,督促企业建立完善进口牛黄的追溯体系。

  试点区域省级药品监督管理部门应当将上述要求及时通知本行政区域内相关药品上市许可持有人,并督促做好有关工作,切实加强监督管理。

  原《国家药品监督管理局关于进一步加强牛源性及其相关药品监督管理的公告》(国药监注〔2002〕238号)与本公告不一致的,以本公告为准。

  特此公告。

国家药监局海关总署

2025年4月18日

  南京4月21日电(记者朱晓颖)江苏省知识产权局、江苏省知识产权保护中心(江苏省专利信息服务中心)21日在南京发布《江苏人工智能产业专利白皮书》。《白皮书》公布的数据显示,上海、江苏、浙江三地的人工智能专利申请量占中国的五分之一。

  《白皮书》统计,截至2025年4月9日,全球人工智能专利申请量为4085647件。从全球专利区域分布看,中国专利申请量达1576379件,占全球申请量的38.58%,位居全球首位。

  《白皮书》统计,从中国国内的专利区域分布看,截至2025年4月9日,中国人工智能专利申请主要集中在北京、广东、江苏、浙江、上海,专利申请量分别为314575件、311481件、122462件、106175件、100690件,占总量的60.61%。

  江苏人工智能产业在人工智能硬件平台、人工智能通用技术、人工智能关键技术领域,均有大量专利申请,主要集中在南京、苏州、无锡三市。2024年,江苏省民营企业人工智能产业发明专利申请公开量8581件,居全国第三位;发明专利授权量4458件,居全国第四位;实用新型专利授权量306件,居全国第二位。从海外布局看,江苏人工智能产业海外布局专利共3100件。(完) 学渣坐在学霸的鸡叭上写:的儿童模式与家长控制功能的相关文章 网传南宋古墓出土的高精度心脏模型,是真的吗?的相关文章
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