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深刻认识药品监管新属性新使命 ——一论贯彻落实全国药品监管工作会议精神

2019-01-16 佚名 中国医药报

刚刚闭幕的全国药品监督管理工作会议对2019年工作进行了部署。会议要求科学准确判断工作形势要求,健全完善监管体制机制,创新监管方式方法,强化风险治理,深化责任落实,提高药品监管的科学化、法治化、国际化、现代化水平,切实保障人民群众用药安全有效。自今日起,本报推出“贯彻全国药监工作会议精神系列谈”栏目,全面学习贯彻会议精神,敬请关注。

刚刚闭幕的全国药品监督管理工作会议对2019年工作进行了部署。会议要求科学准确判断工作形势要求,健全完善监管体制机制,创新监管方式方法,强化风险治理,深化责任落实,提高药品监管的科学化、法治化、国际化、现代化水平,切实保障人民群众用药安全有效。自今日起,本报推出“贯彻全国药监工作会议精神系列谈”栏目,全面学习贯彻会议精神,敬请关注。

一个时代有一个时代的主题,一代人有一代人的使命。

进入新时代,新形势新任务赋予药品监管哪些新属性?药品监管工作在服从大局、服务于大局中如何更好地肩负起新使命?辨方位而正则。全国药品监管工作会议以习近平新时代中国特色社会主义思想为指导,从党和国家事业大局出发,顺应改革发展大势,紧跟时代前进步伐,深刻阐述了药品监管在新时代的新属性、新定位。明确新属性、新定位,对于统一思想、统一行动,站到新起点、开启新征程,肩负新使命、谱写新篇章,意义重大,影响深远。

习近平总书记指出,“药品安全责任重于泰山。保障药品安全是技术问题、管理工作,也是道德问题、民心工程。”“监管工作一定要跟上。”“要下更大力气抓好食品药品安全”。习近平总书记对药品监管工作的一系列重要指示精神,是我们深刻认识、准确把握新时代药品监管新属性、新定位的思想武器,是我们正确履行新时代药品监管新职能、新使命的行动指南。

要深刻认识保障药品安全是严肃的政治问题。政治是具体的。没有脱离政治的业务,也没有脱离业务的政治。药品安全工作做得好不好,人民群众满意不满意,关系到政府公信力,关系到党的执政基础。为此,我们必须把药品监管工作放在党和国家事业的大局中去思考和谋划,从维护以习近平同志为核心的党中央权威的高度、从巩固党的执政根基的高度来认识、看待药品安全问题,切实在药品监管这条战线上为党守土有责、守土负责、守土尽责。

要深刻认识保障药品安全是重大的经济问题。医药行业是关系国计民生、社会稳定和经济发展的新兴战略性产业,被称为“永不衰落的朝阳产业”。中国是全球第二大医药市场和第二大化妆品市场。药品监管直接关系到产业安全、经济安全、国家安全,关系到产品质量、市场供给和民生保障。为此,我们要持续完善监管制度,通过政策引导、有效监管和优化服务,为企业转型升级、经济高质量发展提供更好更大的动力。

要深刻认识保障药品安全是基本的民生问题。药品与每个家庭的生活密切相关,药品安全是人命关天的大事。保障药品安全有效,及时用上新药、好药、便宜药,是群众最关心、最直接、最现实的民生问题。为此,我们要坚持以人民为中心的发展思想,坚守质量安全底线,推动供给质量提升,更好满足人民日益增长的美好生活需要,特别是人民日益增长的健康需要,切实提升人民的获得感和满意度。

要深刻认识保障药品安全是严谨的技术问题。医药产业是技术密集型产业,药监部门是政策性、专业性很强的部门。药品监管既是行政管理,也是专业化的技术管理,需要监管者运用专业知识,在各环节对相对人行为的合法性、合规性、合理性及至伦理符合性进行准确的判断和处置。随着网络化、高科技涉药犯罪行为的增加,对药品监管的专业能力提出了新的更高要求。为此,我们必须走专业化的道路,大力发展监管科学,强化技术支撑,努力做到科学、权威。

明确新属性,履行新使命,“知之愈明,则行之愈笃;行之愈笃,则知之益明”。今年是药品监管事业大有作为的一年,我们要把党的信任和重托牢记心上,把对历史和人民的责任扛在肩上,担当作为,开拓奋进,为谱写新时代药品监管新篇章起好头、定好调。

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    2019-01-18 wwzzly

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CFDA发布《药品境外检查规定》意见稿 强化进口药品监管

8月31日,CFDA官网发布信息,公开征求《药品境外检查规定(征求意见稿)》(以下简称意见稿)意见。有关意见需在9月24日前以电子邮件形式反馈至CFDA。

Pharmacoepidem Dr S:罗格列酮的临床证据和药品监管变化对降糖治疗处方模式的影响

2017年11月,发表在《Pharmacoepidemiol Drug Saf》的一项由韩国科学家进行的研究考察了罗格列酮的临床证据更新和药品监管变化对抗糖尿病治疗处方模式的影响。

中药饮片市场超2700亿元 谁会是下一个巨头?

中药饮片市场规模已经从2011年853.7亿增长至2016年的1956亿元,4年复合增速19%,增速领跑医药工业各子行业

站在新起点上,开拓药品监管新境界

刚刚闭幕的全国药品监督管理工作会议,认真总结去年药品监管工作,深入分析当前药品监管形势,全面部署今年药品监管工作,对于我们进一步统一思想,站在新起点上,开拓药品监管新境界,奋力谱写新时代药品监管事业新篇章,具有重要意义。

药监领导大调整,史上强大药品监管来了

药监领导大调整,史上最强的药品整治风暴来了!

Nature综述——改革三年来:中国药品监管体系的努力与成效

2015年8月18日,国务院发布《关于药品医疗器械审评审批制度的意见》,标志着全方位强制性改革计划的启动。本文将按时间顺序回顾中国政府从2015年至今,在构建更加科学有效的药品监管体系方面所做的努力(见图1)。

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