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药监局长:是得罪一个企业,还是得罪整个社会?--亲稳网络舆情监控室
2013-01-11

  “‘查’会很辛苦,甚至会得罪人,但对监管队伍来说,是得罪一个人、一个企业,还是得罪整个社会?”今天,国家食品药品监督管理局局长尹力用这样的反问鼓励药监工作人员加强对检查的重视。

"‘check’Will be very hard,Even to upset people,But for supervision for the team,Is against a person/An enterprise,Or against the society as a whole?"today,State food and drug administration YinLiYong such rhetorical question also encourage staff to strengthen the attention of the inspection.

  在今天召开的2013年全国食品药品监督管理暨党风廉政建设工作会议上,尹力说,要改变长期以来重审批、轻监管的倾向,保证审批的产品安全有效、质量可控。在今后的食品药品监管上,必须妥善处理审、批、查的关系,加快监管方式转变。

Today at the 2013 national food and drug supervision and administration and the party construction of a clean and honest administration work meeting,YinLi said,Want to change for a long time heavy examination and approval/The tendency of light regulation,Ensure that the examination and approval of the product is safe and effective/Quality controlled.In the future on the food and drug administration,Must properly handle the trial/batch/Check relationship,To speed up the supervision mode change.

  尹力表示,审是批的基础,批是在审的基础上依法行政,查是审和批的延续,是当前工作必须加强的重要方面。只有查,才能体现审和批的价值。审、批、查的任何疏漏都会带来风险,都必须承担责任。

YinLi said,Review is the basis of the group,Batch is in the basis of careful administration according to law,Check is a continuation of the trial and batch,Is currently an important aspect of work must be strengthened.Only check,To reflect the value of the trial and batch.trial/batch/Check any omissions will bring risk,Must bear the responsibility.

  最近几年,有关食品药品安全的事件数次发生。尹力认为,之所以会出现这些事件,就是因为风险没有得到控制。在医药产业的整个链条中,有利益就会有风险,如果不能把众多环节中的风险识别出来,风险就会转移到监管者身上。

In recent years,The food and drug safety events happened several times.YinLi think,The reason for causing these events,Because the risk is not under control.In the medicine industry in the whole chain,Have interests will have risk,If you can't put many link risk identified,Risk will be transferred to the regulators body.

  

如何辨别这些风险? How to identify the risk?

  尹力给出的方法是,把产业链转化为责任链,让每个利益环节真正承担起相应的责任。

YinLi method is given,The industrial chain into the chain of responsibility,Let each interests link real assume corresponding responsibility.

  而要把产业链转化为责任链,则要建立健全质量追溯制度;把风险管理的方法融入监管工作中,在法规制度修订、工作程序安排上体现风险管理理念;严格执行监管法规制度,增加企业、从业人员违法成本,建立企业信用等级和从业人员诚信档案,让依法经营成为企业自觉。

And the industry chain into the chain of responsibility,Is to establish and perfect the quality tracking system;The risk management method into the supervision work,In the revised laws and regulations/Job scheduling is reflected on the risk management idea;Strict implementation of the supervision system of laws and regulations,Increase enterprise/Employees illegal cost,Establish enterprise credit rating and practitioners credit files,To manage according to the law to become the enterprise consciously.

  “这是解决我国食品药品安全问题的根本所在,也是全面提升食品药品监管水平的关键。”尹力说,目前国家药监局所监管的餐饮、药品、医疗器械、保健食品、化妆品的经济总量要占GDP的9%左右,这些行业技术革新日新月异,对监管提出了新要求,监管需要找到更有效的方法。

"This is to resolve our country's food and drug safety in the root of the problem,The food and drug supervision and improve the level of the key."YinLi said,At present the country's drug watchdog over food/drug/Medical devices/Health food/Cosmetics economic total amount to about 9% of GDP,These industry technical innovation change with each passing day,For regulatory puts forward new requirements,Supervision need to find more effective method.

  尹力表示,现在社会对监管队伍的期望很高,要求也很高。到下面调研的时候要多看存在的问题,而不是多看成果展示。要把正在做的、想做的、应做的事情告诉社会,取得支持;难以做到,或者是需要一定条件才能做到的事情要取得社会的谅解;对做的不够好的、自己不以为然的事情,要听取各方面的意见。

YinLi said,Now the social supervision team's high expectations,Requirement is high.The research of the time to see problems,Not see results show.To put is doing/Want to do/Should do tell society,Obtains the support;hard,Or need certain conditions to do things to get social understanding;To do is not good/I don't think it's things,To hear the opinions of the concerned.

  据介绍,2012年共吊销药品生产许可证13张、药品经营许可证217张、医疗机构制剂许可证1张、医疗器械经营许可证12张,吊销药品生产质量管理规范证书5张、药品经营质量管理规范证书109张。(记者李松涛)

According to introducing,2012 shall revoke the pharmaceutical production license and zhang/Drug business license 217 copies/Preparation of medical institution license 1 a/Medical equipment business licenses and zhang,Shall revoke the pharmaceutical production quality management standard certificate five tickets/The quality control standard for pharmaceutical business certificate 109 copies.(Reporter LiSongTao)


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