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七部委发文推动解决药品安全领域诚信缺失问题--亲稳网络舆情监测室
2012-10-30

  中新网10月30日电 据国家发展和改革委员会网站消息,发展改革委、人民银行等七部委联合印发了《关于进一步加强药品安全信用体系建设工作的指导意见》。 《指导意见》强调,要完善药品流通体系,健全准入退出机制,加强药品广告监管,规范药品广告发布活动。

Beijing, oct. 30, according to the national development and reform commission website news,Development and reform commission/The people's bank and other seven ministries jointly issued by the[On further strengthening drug safety credit system construction work instruction opinion]. [Guiding opinions]emphasize,To perfect the medicine circulation system,Improve the access exit mechanism,Strengthen the drug advertising supervision,Standard drug advertising publishing activities.

  药品安全事关人民群众切身利益、经济健康发展和社会和谐稳定。多年来,药品安全领域一直存在不同程度的诚信缺失问题,尤其是毒胶囊事件曝光后,社会对药品安全问题的反响十分强烈。 

Drug safety is the vital interests of the people/The healthy development of the economy and social harmony and stability.For many years,Drug safety fields have been there exists different degree of lack of credibility,Especially poison capsule events after exposure,Society for drug safety problem is very strong repercussions. 

  为切实推动解决药品安全领域诚信缺失问题,2012年9月4日,发展改革委、人民银行、工业和信息化部、商务部、卫生部、工商总局和食品药品监管局等七部委联合印发了《关于进一步加强药品安全信用体系建设工作的指导意见》 。

In order to promote solve the lack of credibility of drug safety field,On September 4, 2012,Development and reform commission/People's bank of/Ministry of industry and information/The ministry of commerce/The ministry of health/Administration for industry and commerce and food and drug supervision bureau jointly issued by the other seven ministries and commissions[On further strengthening drug safety credit system construction work instruction opinion] .

  《指导意见》共提出了13个方面的任务和要求:(1)建立健全药品研制环节信用体系建设;(2)建立健全药品企业产品质量信用管理体系;(3)完善药品流通体系,健全准入退出机制;(4)建立科学规范的药品招标采购机制;(5)建立药物临床使用评价制度;(6)加强药品广告监管,规范药品广告发布活动;(7)加快完善药品安全领域信用制度建设;(8)加快药品行业信用信息资源整合;(9)建立健全信用分类监管机制;(10)严格落实药品生产和经营主体责任,加强失信行为的联合惩戒;(11)积极发挥行业协会的推动和自律作用;(12)进一步加强部门之间的协同合作;(13)开展诚信宣传教育,完善社会监督机制。

[Guiding opinions]A total of 13 aspects put forward the tasks and requirements:(1)Establish and perfect the medicine development link credit system construction;(2)Establish and perfect the medicine enterprise product quality credit management system;(3)Perfect the medicine circulation system,Improve the access exit mechanism;(4)To establish a scientific and standardized drug bidding procurement mechanism;(5)Establish drug clinical use evaluation system;(6)Strengthen the drug advertising supervision,Standard drug advertising publishing activities;(7)Speed up improvement of drug safety credit system construction field;(8)To speed up the drugs industry credit information resource integration;(9)Setting up and perfecting the credit classified supervision mechanism;(10)Strictly implement pharmaceutical production and management main body responsibility,Strengthen discreditable behavior of joint discipline;(11)To give full play to the industry association to promote and self-discipline function;(12)To further strengthen the collaboration between departments;(13)In good faith propaganda education,Perfect social supervision mechanism.

  其中,前六个方面对药品安全领域各环节(研发、产品质量、流通、招标采购、临床使用、广告)的信用建设提出了具体要求;后七个方面主要从药品安全信用体系建设的运行机制和保障措施(制度建设、信息资源整合、分类监管、失信联合惩戒、行业自律、部门协同、宣传教育)角度提出要求。

the,The first six aspects of each link drug safety field(r&d/Product quality/circulation/Bidding procurement/Clinical use/advertising)Credit construction puts forward specific requirements;After seven aspects mainly from the drug safety credit system construction operation mechanism and the safeguard measures(System construction/Information resource integration/Classification regulation/Faithless joint disciplinary/self-discipline/Department coordination/Propaganda education)Angle request.


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