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</div> <span class="want_line"></span> <div class="want"> <a href="/buyPublish" target="_blank">我要采购</a> <a href="/zt/maoyitong/tradePass.php" target="_blank">我要供应</a> <a href="/zt/companycenter/userservice.html" target="_blank">我要推广 </a> </div> </div> <div style="clear: both"></div> </div> <div class="zy_top zy-top_bottom"> <div class="zhiyao_nav_all contain"> <div class="visibleBox"> <div class="cont_l"> <div class="c_l_top"> <i class="iconfont icon-caidan"></i> 产品分类导航 </div> <div class="c_l_list"> <ul> <li> <span> <a href="/Products/list-htm-catid-4.html"> 原料药</a> </span> <div class="list_list"> <div class="title"> <a href="/Products/list-htm-catid-4.html" target="_blank">原料药</a> </div> <div class="list_list_item"> <a href="/Products/list-htm-catid-5.html"> 维生素类</a> <a href="/Products/list-htm-catid-6.html"> 四环素类</a> <a href="/Products/list-htm-catid-7.html"> 青霉素类</a> <a href="/Products/list-htm-catid-8.html"> 头孢菌素类</a> <a href="/Products/list-htm-catid-9.html"> 激素类</a> <a href="/Products/list-htm-catid-10.html"> 氨基酸及其衍生物</a> <a href="/Products/list-htm-catid-11.html"> 氨基糖苷类</a> <a href="/Products/list-htm-catid-12.html"> 大环内酯类</a> <a href="/Products/list-htm-catid-13.html"> 磺胺类</a> <a href="/Products/list-htm-catid-14.html"> 氯霉素类</a> <a href="/Products/list-htm-catid-15.html"> 林可霉素类</a> <a href="/Products/list-htm-catid-16.html"> 呼吸系统用药</a> <a href="/Products/list-htm-catid-17.html"> 解热镇痛药</a> <a href="/Products/list-htm-catid-18.html"> 消化系统用药</a> <a href="/Products/list-htm-catid-19.html"> 心血管系统用药</a> <a href="/Products/list-htm-catid-20.html"> 中枢神经系统用药</a> <a href="/Products/list-htm-catid-21.html"> 麻醉用药</a> <a href="/Products/list-htm-catid-22.html"> 其他抗感染类</a> <a href="/Products/list-htm-catid-23.html"> 抗寄生虫病药</a> <a href="/Products/list-htm-catid-24.html"> 其他西药原料</a> </div> <div class="list_list_img"> </div> </div> </li> <li> <span> <a href="/Products/list-htm-catid-25.html"> 中间体</a> </span> <div class="list_list"> <div class="title"> <a href="/Products/list-htm-catid-25.html" target="_blank">中间体</a> </div> <div class="list_list_item"> <a href="/Products/list-htm-catid-26.html"> 医药中间体</a> <a href="/Products/list-htm-catid-27.html"> 农药中间体</a> <a href="/Products/list-htm-catid-28.html"> 其他中间体</a> <a href="/Products/list-htm-catid-355.html"> 精细化工</a> </div> <div class="list_list_img"> </div> </div> </li> <li> <span> <a href="/Products/list-htm-catid-29.html"> 生物制品</a> </span> <div class="list_list"> <div class="title"> <a href="/Products/list-htm-catid-29.html" target="_blank">生物制品</a> </div> <div class="list_list_item"> <a href="/Products/list-htm-catid-30.html"> 试剂</a> <a href="/Products/list-htm-catid-63.html"> 生物技术服务</a> <a href="/Products/list-htm-catid-665.html"> 生物制剂</a> </div> <div class="list_list_img"> </div> </div> </li> <li> <span> <a href="/Products/list-htm-catid-75.html"> 天然提取物</a> </span> <div class="list_list"> <div class="title"> <a href="/Products/list-htm-catid-75.html" target="_blank">天然提取物</a> </div> <div class="list_list_item"> <a href="/Products/list-htm-catid-76.html"> 植物提取物</a> <a href="/Products/list-htm-catid-77.html"> 动物提取物</a> <a href="/Products/list-htm-catid-646.html"> 微生物提取物</a> <a href="/Products/list-htm-catid-671.html"> 功能性食品原料</a> <a href="/Products/list-htm-catid-672.html"> 食品、饮料原料</a> <a href="/Products/list-htm-catid-673.html"> 保健品原料</a> <a href="/Products/list-htm-catid-674.html"> 膳食补充剂</a> <a href="/Products/list-htm-catid-675.html"> 中药原料</a> <a href="/Products/list-htm-catid-676.html"> 美容化妆品原料</a> <a href="/Products/list-htm-catid-940.html"> 其他天然提取物</a> </div> <div class="list_list_img"> </div> </div> </li> <li> <span> <a href="/Products/list-htm-catid-78.html"> 药品制剂</a> </span> <div class="list_list"> <div class="title"> <a href="/Products/list-htm-catid-78.html" target="_blank">药品制剂</a> </div> <div class="list_list_item"> <a href="/Products/list-htm-catid-79.html"> 抗肿瘤制剂</a> <a href="/Products/list-htm-catid-80.html"> 抗寄生虫制剂</a> <a href="/Products/list-htm-catid-81.html"> 抗过敏用制剂</a> <a href="/Products/list-htm-catid-82.html"> 抗菌药与抗病毒药制剂</a> <a href="/Products/list-htm-catid-83.html"> 抗结核及麻风制剂</a> <a href="/Products/list-htm-catid-84.html"> 皮肤科制剂</a> <a href="/Products/list-htm-catid-85.html"> 五官科制剂</a> <a href="/Products/list-htm-catid-86.html"> 消化系统制剂</a> <a href="/Products/list-htm-catid-87.html"> 呼吸系统制剂</a> <a href="/Products/list-htm-catid-88.html"> 循环系统制剂</a> <a href="/Products/list-htm-catid-89.html"> 神经系统类制剂</a> <a href="/Products/list-htm-catid-90.html"> 血液系统药制剂</a> <a href="/Products/list-htm-catid-91.html"> 泌尿与生殖系统制剂</a> <a href="/Products/list-htm-catid-93.html"> 调节免疫功能制剂</a> <a href="/Products/list-htm-catid-94.html"> 调节水、电解质及酸碱平衡制剂</a> <a href="/Products/list-htm-catid-95.html"> 维生素、矿物质与氨基酸类制剂</a> <a href="/Products/list-htm-catid-96.html"> 酶类及其它生化制剂</a> <a href="/Products/list-htm-catid-97.html"> 解热镇痛类制剂</a> <a href="/Products/list-htm-catid-98.html"> 滋补营养药</a> <a href="/Products/list-htm-catid-99.html"> 有关激素类药</a> <a href="/Products/list-htm-catid-100.html"> 内分泌及代谢类制剂</a> <a href="/Products/list-htm-catid-101.html"> 清热解毒制剂</a> <a href="/Products/list-htm-catid-102.html"> 心脑血管类制剂</a> <a href="/Products/list-htm-catid-103.html"> 其它药品制剂</a> </div> <div class="list_list_img"> </div> </div> </li> <li> <span> <a href="/Products/list-htm-catid-104.html"> 药用辅料</a> </span> <div class="list_list"> <div class="title"> <a href="/Products/list-htm-catid-104.html" target="_blank">药用辅料</a> </div> <div class="list_list_item"> <a href="/Products/list-htm-catid-105.html"> 赋形剂</a> <a href="/Products/list-htm-catid-106.html"> 崩解剂</a> <a href="/Products/list-htm-catid-107.html"> 润滑剂</a> <a href="/Products/list-htm-catid-108.html"> 助流剂</a> <a href="/Products/list-htm-catid-109.html"> 包衣材料</a> <a href="/Products/list-htm-catid-110.html"> 增塑剂</a> <a href="/Products/list-htm-catid-111.html"> 肠溶材料</a> <a href="/Products/list-htm-catid-112.html"> 表面活性剂</a> <a href="/Products/list-htm-catid-113.html"> 溶媒</a> <a href="/Products/list-htm-catid-114.html"> 抗氧剂</a> <a href="/Products/list-htm-catid-115.html"> 遮光剂</a> <a href="/Products/list-htm-catid-116.html"> 矫味剂</a> <a href="/Products/list-htm-catid-117.html"> 甜味剂</a> <a href="/Products/list-htm-catid-118.html"> 香精</a> <a href="/Products/list-htm-catid-119.html"> 着色剂</a> <a href="/Products/list-htm-catid-120.html"> 促透剂</a> <a href="/Products/list-htm-catid-121.html"> 助滤剂</a> <a href="/Products/list-htm-catid-122.html"> 澄清剂</a> <a href="/Products/list-htm-catid-123.html"> 防腐剂</a> <a href="/Products/list-htm-catid-124.html"> 稳定剂</a> <a href="/Products/list-htm-catid-125.html"> ＰＨ调节剂</a> <a href="/Products/list-htm-catid-126.html"> 催化剂</a> <a href="/Products/list-htm-catid-127.html"> 其他药用辅料</a> </div> <div class="list_list_img"> </div> </div> </li> <li> <span> <a href="/Products/list-htm-catid-128.html"> 合同外包、定制服务及咨询</a> </span> <div class="list_list"> <div class="title"> <a href="/Products/list-htm-catid-128.html" target="_blank">合同外包、定制服务及咨询</a> </div> <div class="list_list_item"> <a href="/Products/list-htm-catid-129.html"> 合同研发外包</a> <a href="/Products/list-htm-catid-130.html"> 合同生产外包</a> <a href="/Products/list-htm-catid-131.html"> 咨询与服务</a> </div> <div class="list_list_img"> </div> </div> </li> <li> <span> <a href="/Products/list-htm-catid-162.html"> 原料药设备</a> </span> <div class="list_list"> <div class="title"> <a href="/Products/list-htm-catid-162.html" target="_blank">原料药设备</a> </div> <div class="list_list_item"> <a href="/Products/list-htm-catid-163.html"> 反应设备</a> <a href="/Products/list-htm-catid-164.html"> 干燥设备</a> <a href="/Products/list-htm-catid-165.html"> 结晶设备</a> <a href="/Products/list-htm-catid-167.html"> 萃取设备</a> <a href="/Products/list-htm-catid-168.html"> 换热器</a> <a href="/Products/list-htm-catid-169.html"> 储存设备</a> <a href="/Products/list-htm-catid-170.html"> 过滤分离</a> <a href="/Products/list-htm-catid-171.html"> 蒸发设备</a> <a href="/Products/list-htm-catid-172.html"> 蒸馏设备</a> <a href="/Products/list-htm-catid-173.html"> 筛分机械</a> <a href="/Products/list-htm-catid-174.html"> 灭菌设备</a> <a href="/Products/list-htm-catid-175.html"> 压滤设备</a> <a href="/Products/list-htm-catid-176.html"> 均质机</a> <a href="/Products/list-htm-catid-177.html"> 其它原料药设备</a> <a href="/Products/list-htm-catid-950.html"> 发酵设备</a> </div> <div class="list_list_img"> </div> </div> </li> <li> <span> <a href="/Products/list-htm-catid-178.html"> 制剂设备</a> </span> <div class="list_list"> <div class="title"> <a href="/Products/list-htm-catid-178.html" target="_blank">制剂设备</a> </div> <div class="list_list_item"> <a href="/Products/list-htm-catid-204.html"> 混合设备</a> <a href="/Products/list-htm-catid-951.html"> 颗粒设备</a> <a href="/Products/list-htm-catid-957.html"> 片剂设备</a> <a href="/Products/list-htm-catid-960.html"> 胶囊剂设备</a> <a href="/Products/list-htm-catid-964.html"> 粉碎设备</a> <a href="/Products/list-htm-catid-969.html"> 液体制剂设备</a> <a 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href="/news/">资讯</a> <label>></label> <a href="javascript:;">徐景和：科学监管助力医药强国建设</a> <label>></label> </div> </div> <div class="newsDetail"> <div class="content flex_between"> <input id="newsId" type="hidden" value="205308"/> <div class="newsDetail_article"> <div class="zixun-contain"> <h1 class="newsDetail_article_title">徐景和：科学监管助力医药强国建设</h1> <div class="newsDetail_article_create flex_between"> <div class="exam_news_createlocal"> 热门推荐： <a href="/news/search-htm-txtSearch-中国药促会-hide_search-4.html">中国药促会</a> <label>,</label> <a href="/news/search-htm-txtSearch-药品监管-hide_search-4.html">药品监管</a> <label>,</label> <a href="/news/search-htm-txtSearch-徐景和-hide_search-4.html">徐景和</a> <label>,</label> </div> <div class="exam_news_createtime" style="display: flex"> <div> 来源：CPHI制药在线</div>   2023-04-14</div> </div> <div class="news-brief"> 3月29日，由中国医药创新促进会主办的第七届中国医药创新与投资大会在苏州启幕，国家药监局党组成员、副局长徐景和出席大会并做重要讲话。 </div> <div class="newsDetail_article_content"> <p> 3月29日，由中国医药创新促进会主办的第七届中国医药创新与投资大会在苏州启幕，国家药监局党组成员、副局长徐景和出席大会并做重要讲话。</p> <p style="text-align: center;"><img alt="徐景和" src="https://cimg.cphi.cn/img_Cphi_cn/news/2023_04/Mimg_2304140614297342.png" style="height:330px; width:500px" /></p> <p> 最新数据显示，中国对全球医药研发管线产品数量的贡献已由2015年的4%跃升至2022年的20%，中国药品市场已占全球药品市场的20.3%，中国医疗器械市场已占全球市场的27.5%，2022年药品制造业营业收入已达到4.2万亿元（其中药品2.9万亿元，医疗器械1.3万亿元），中国已成为全球药品市场增长的重要贡献者。</p> <p> “当前，药品医疗器械审评审批制度改革创新的许多措施和重要成果已载入国家法律法规，以法治方式得以巩固和深化。审评审批制度改革创新坚定不移地向前推进。”徐景和指出，国家药监局新组建五年来，我们更加自觉地将药品监管工作放在党和国家工作大局中来谋划和推动，更加积极地推动药品监管科学研究助力产业创新高质量发展，更加自信地参与国际药品监管交流与合作努力贡献中国智慧和力量。五年来，我们坚持守底线保安全、追高线促发展，努力营造鼓励支持医药产业创新的生态环境，充分释放产业发展活力，为经济社会发展和人民健康生活带来了深远影响。</p> <p> <strong> 监管事业实现大发展、大变革、大进步</strong></p> <p> 2018年国家药监局新组建以来，我们认真贯彻落实党中央国务院重大决策部署，以“四个最严”为根本遵循，以保护和促进公众健康为监管使命，以“创新、质量、效率、体系、能力”为发展主题，以加快实现从制药大国到制药强国跨越为发展目标，以科学化、法治化、国际化、现代化为发展道路，以守底线保安全、追高线促发展为基本任务，加快推进药品监管科学行动计划和智慧监管行动计划，推出了许多创新性举措，推进了许多变革性实践，实现了监管事业的大发展、大变革、大进步。</p> <p> <strong>一是法律法规打造“升级版”。</strong>我们坚持政治引领，坚持问题导向，坚持国际视野，坚持改革创新，坚持科学发展，制修订《药品管理法》《疫 苗管理法》《医疗器械监督管理条例》《化妆品监督管理条例》及其配套规章制度，确定了风险管理、全程管控、科学监管、社会共治的基本原则，建立了药品上市许可持有人制度，改革了临床评价和临床试验管理制度，推出了违法行为处罚到人制度，打造了我国药品监管法律制度的升级版现代版。</p> <p> <strong> 二是审评审批跑出“加速度”。</strong>2015年审评审批制度改革启动时积压问题严重。今天，药品医疗器械已基本实现按法定时限审评审批。2022年，全年批准上市药品1279个，其中创新药18个。国家局批准2500个首次注册的医疗器械产品，其中创新医疗器械55个。五年来，共有106个创新药、192个创新医疗器械上市。仿制药质量和疗效一致性评价取得历史性进步。通过仿制药质量和疗效一致性评价的品种已超过临床常用药品品种的一半，有效实现了国产仿制药与进口原研药的相互替代，为支持国家药品集采工作，为推动健康中国建设作出了重要贡献。目前药品审评技术指导原则达到426个，医疗器械审评技术指导原则达534个，为药械研发创新提供了强有力的支撑。</p> <p> <strong>三是监管科学步入“快车道”。</strong>为进一步提升监管工作的科学性、前瞻性和适应性，2019年4月启动中国药品监管科学行动计划，实施了细胞和基因治疗产品、纳米类创新药械、新型生物材料等两批19个监管科学项目。与高等院校科研机构合作，设立14个监管科学研究基地、认定117家重点实验室。建立人工智能医疗器械和生物材料2个创新协作平台。一批监管新工具、新标准、新方法陆续开发应用，正在助推药品监管能力提升和药品产业创新发展。</p> <p> <strong>四是能力建设开辟“新局面”。</strong>国务院出台了《关于全面加强药品监管能力建设的实施意见》《关于建立职业化专业化药品检查员队伍的意见》。按照强基础、补短板、破瓶颈、促提升，对标国际通行规则的要求，全系统持续加大监管能力建设和职业化专业化检查员队伍建设推进力度。设立长三角和大湾区4个药品医疗器械审评检查分中心。设立国家疫 苗检查中心、特殊药品检查中心。药审中心新增编制160名。药审中心和器审中心推进政府购买服务试点。各省局加强派出机构和队伍建设，监管力量明显增强。</p> <p> <strong>五是疫情防控彰显“高效率”。</strong>新冠肺炎疫情发生后，全系统全力以赴，尽锐出战，建立研审联动、随到随审的超常规运行机制，附条件批准5个新冠病毒疫 苗上市，8个新冠病毒疫 苗经论证紧急使用。批准15个新冠治疗药物上市或增加适应症，批准143个新冠病毒检测试剂上市，在大疫大考中充分展现了广大药监干部的使命担当。累计向153个国家和15个国际组织提供超过22亿剂新冠疫 苗，积极践行中国新冠疫 苗产品作为全球公共产品的庄严承诺。</p> <p> <strong>六是全程监管压实“责任链”。</strong>去年，国务院成立集中打击整治危害药品安全违法犯罪工作领导小组，深入开展药品安全专项整治行动，重拳打击违法违规行为，全面彻查安全风险隐患。国家药监局出台药品、医疗器械和化妆品主体责任落实规定，强化企业全生命周期质量安全管理责任落实，推进企业质量管理体系持续合规。以问题为导向，改革完善监督检查、产品抽验、网络监测运行机制，强化监管工作的主动性、针对性和靶向性。聚焦问题、聚焦产品、聚焦企业、聚焦处置，全面开展风险会商和隐患排查，药品安全形势持续稳中向好。</p> <p> <strong>七是国际合作谱写“新篇章”。</strong>持续加强与世界卫生组织（WHO）、国际药品监管机构联盟（ICMRA）、国际人用药品注册技术协调会（ICH）、国际医疗器械监管者论坛（IMDRF）和全球医疗器械法规协调会（GHWP）的交流与合作。再次当选ICH管委会成员。启动加入药品检查合作机制（PIC/S）预申请程序，积极参与国际化妆品监管合作组织（ICCR）相关工作。</p> <p><strong> 加快从制药大国向制药强国跨越</strong></p> <p> 党的二十大提出了中国式现代化的重大命题。如果说，新时代新征程是定位，现代化是定势，中国式则是定力。中国式现代化体现了中华民族的自立自强、展示了中华民族的智慧力量，激发了中华民族的创造伟力，描绘了中华民族的灿烂前景。党的二十大强调，要强化药品安全监管；深化医药卫生体制改革，促进医保、医疗、医药协同发展和治理；促进中医药传承创新发展。这为我国药品监管事业发展指明了前进方向。当前，我国正处于从制药大国向制约强国跨越、从仿制为主向创新引领跨越、从高速增长向高质量发展跨越、药品监管从工业时代向信息时代跨越的重要阶段。前进道路上会有许许多多的挑战，但中国药品监管事业已站在新的起跑线上。</p> <p> 今年的全国药品监管会议上提出了推进中国式药品监管现代化的重大课题，对未来成长与进步，我们将始终保持战略清醒、战略自信和战略坚定。新时代新征程上，我们将全面贯彻落实习近平新时代中国特色社会主义思想，坚持“讲政治、强监管、保安全、促发展、惠民生”，坚持人民至上，保持战略定力，深化改革创新，推进科学发展，努力提升制度创造力、全球竞争力和公众信赖力，努力让广大人民群众和广大医药产业有更多的获得感，让广大的监管者有更多的成就感。</p> <p> 今天，人们追问的是，哪些国家是制药强国？我们离制药强国到底还有多远距离？如何才能早日实现制药强国的伟大梦想？综合分析，作为制药强国，至少应当具备五个条件。</p> <p> <strong>一要打造显著的制度优势。</strong>制度优势是一个国家的最大优势，制度竞争是国家间最根本的竞争。多年的改革创新启示我们，制度是生产力的第四要素，是生产力的幂指数。纵观世界，没有哪个制药强国不高度重视法律制度对于药品创新生态环境的精心塑造。法治具有固根本、稳预期、利长远的重要作用。我们要精心打造理念现代、价值和谐、制度完备、机制健全的现代法治，以良好的制度链，催生优秀的创新链、造就强大的产业链。</p> <p> <strong> 二要培育优秀的产业群体。</strong>翻开世界药品、医疗器械百强企业榜单，这些优秀的企业无不在产业规模、研发投入、产品创新上占据显著优势。产业群体决定了一个国家的药品综合实力和国际竞争力。我们必须打造一批具有国际竞争力的创新型领军医药企业，这是制药强国的鲜明标志。</p> <p> <strong>三要拥有卓越的创新能力。</strong>当前，全球科技创新进入空前密集活跃期，深刻影响着国家前途命运和人民生活福祉。生物医药领域是目前国际上争夺技术创新高地的竞争最激烈的领域。习近平总书记多次强调，惟创新者进、惟创新者强、惟创新者胜。拥有卓越的创新能力是实现产业自立自强的前提。</p> <p> <strong>四要建立完善的监管体系。</strong>拥有强大监管体系和监管能力是医药产业具有全球竞争优势的基础。哪个国家的监管体系完善，哪个国家的药品就更容易获得国际的认可。只要强大的监管机构才能有效保护和促进公众健康。</p> <p> <strong>五要拥有重大的国际影响。</strong>当前，全球药品领域正在积极推进监管趋同、监管协调和监管信赖，而拥有足够的监管能力是参与推进并发挥作用的重要前提。作为制药强国，应当在全球医药产业发展和药品监管制度创新中拥有更大的力量，为保护和促进全球公众健康贡献更多的智慧。</p> <p> 第七届中国医药创新与投资大会的成功召开，不仅说明中国药促会有强大的感召力，同时也说明中国药品产业有强大的生命力。真诚希望中国医药创新与投资大会更好发挥桥梁纽带作用，精耕细作，打造精品，为推动医药创新成果及时高效转化、推进制药强国建设发挥积极的促进作用。真诚希望社会各界关心药监支持药监，共同为推进中国式药品监管现代化，保护和促进公众健康贡献更多的智慧和力量。</p> </div> <div class="newsDetail_article_others"> <div class="yuanchuang"> <label>版权所有，未经允许，不得转载。</label> </div> </div> </div> <div class="xiangguantuijian" style="margin-top: 30px;border-bottom: none;"> <div class="xiangguantuijian_title"> <div class="tuijian_title_left"> <div class="tuijian_title_type"></div> <div class="tuijian_title_text">相关文章</div> </div> </div> <div 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