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药监局:加强对原料药等产业聚集区域风险防控--亲稳网络舆情监测室
2013-02-07

  中新网2月6日电 据国家食品药品监督管理局网站消息,全国药品安全监管工作电视电话会议2月4日在京召开,研究部署2013年重点工作。国家食品药品监督管理局党组副书记、副局长吴浈指出,各地要加强对区域性风险的防控,重点关注原料药、辅料、中药饮片、中药提取物、药包材等产业聚集区域。

February 6, according to the state food and drug administration website news,The national drug safety supervision work video and telephone conference on February 4, held in Beijing,Study the deployment of the work.State food and drug administration, deputy secretary of the party/Deputy director wu pointed out,The various localities should strengthen the regional risk prevention and control,Focus on API/accessories/Chinese medicine yinpian/Chinese medicine extract/Medicine packaging material industries gathered area.

  会议充分肯定一年来药品安全监管工作取得的新成绩,分析了当前突出存在的药品安全问题和风险,对2013年的药品安全监管重点工作进行了具体部署,提出坚持以保安全为目标,以发现和控制风险为主要内容,以实施药品GMP、GSP为抓手,努力打造一个法规制度完善、保障基础牢固、风险管控高效的药品安全监管体系。

The meeting full affirmation for one year and drug safety supervision work's achievements,Analyzes the current outstanding existing drug safety and risk,2013 years of drug safety supervision work focus on the specific deployment,To put forward in order to protect security as the goal,To find and control risk as the main content,In order to carry out drug GMP/GSP for gripper,To create a perfect laws and regulations/Security firm foundation/Risk control efficient drug safety supervision system.

  吴浈指出,要切实抓好新修订药品GMP、GSP的实施,坚决做到标准不降低,时间不延长,依法严格把关;要加强政策引导和服务指导,认真落实四部委《关于加快实施新修订药品生产质量管理规范促进医药产业升级有关问题的通知》要求,确保及时完成血液制品、疫苗、注射剂等无菌药品生产企业的检查认证工作。同时,要统筹兼顾,谋划新修订药品GSP的贯彻实施,并以此为契机,推动药品流通领域改革。

Wu pointed out that,We need to pay special attention to the new revised drug GMP/GSP implementation,Resolutely do not reduce the standard,Time not prolong,Strictly in accordance with the;To strengthen policy guidance and service instruction,Earnestly implement the four ministries and commissions[On speeding up the implementation of the new revised drug production quality management standard to promote medical industrial upgrading of the relevant questions of the notice]requirements,Ensure timely complete blood products/vaccine/Injection asepsis pharmaceutical production enterprise inspection certification.At the same time,To plan as a whole to,Plan the new revised drug GSP implement,And as the opportunity,Promote the reform of drug circulation field.

  吴浈表示,只有不断完善药品安全监管的制度机制,才能主动适应日益提高的安全监管需求。2013年,要着力开展药品监管制度研究,落实药品安全责任体系,推动建立药品安全链条式管理,探索提高药品安全保障水平的风险管理模式。同时要以建立药品专职检查员队伍为主要目标,以提高现有队伍素质能力为着眼点,不断强化队伍建设。

Wu said,Only by constantly perfect the drug safety supervision system mechanism,To take the initiative to meet the increasing demand of safety management.In 2013,,To strive to carry out drug supervision system research,Carry out drug safety responsibility system,Promote the establishment of drug safety chain management,Explore the drug safety guarantee to improve the level of risk management mode.At the same time to establish the full-time inspector team as the main target,In order to improve the quality of the existing team ability for starting point,Continuously strengthen the team construction.

  吴浈强调,做好药品安全监管工作,应从分析药品安全监管链条中的风险入手,抓住关键环节和突出问题,特别是严重影响药品质量且可能演变为系统性风险的突出问题。各地要加强对区域性风险的防控,重点关注原料药、辅料、中药饮片、中药提取物、药包材等产业聚集区域;要继续加大对国家基本药物、高风险品种、中成药和原料药的监督检查和风险排查,认真履行安全监管职能。

Wu stressed,Completes the drug safety supervision work,We should analyze the supervision over drug safety in the chain of risk,Seize the key link and outstanding problems,Especially the serious influence the quality of drugs and could become systemic risk problems.The various localities should strengthen the regional risk prevention and control,Focus on API/accessories/Chinese medicine yinpian/Chinese medicine extract/Medicine packaging material industries gathered area;Will continue to strengthen the national essential drugs/High-risk varieties/Traditional Chinese medicine and the supervision and inspection of the drug traffic and risk,Earnestly implement the safety supervision function.


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