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北京将推进儿童用药研究 鼓励药企研发儿童药剂--亲稳舆论引导监测室
2013-01-15

北京将推进儿童用药研究 鼓励药企研发儿童药剂                市药检所工作人员向记者介绍如何鉴别真假中药饮片。 阎彤摄                 The city YaoJianSuo staff introduces to the reporter how to identify true and false Chinese medicine yinpian. YanTong perturbation

  儿童用药缺乏是个在全世界范围普遍存在的难题。记者今天从北京市药监局了解到,今年市药监局将指导儿童用药研究列入了年度重点工作,力争出台相关举措,鼓励企业开展儿童药剂型生产,解决当前儿童用药面临的问题。

The lack of a medicine for children around the world widespread problem.Reporters from the Beijing municipal administration to understand today,This year, the administration's city will guide children's medicine research included in the annual emphases,Strive to publish relevant measures,Encourage enterprises to develop children's drug dosage form production,To solve the current problems of children's medicine.

  北京市药监局有关负责人表示,今年市药监局将启动儿童用药情况调研,掌握本市儿童用药的基本数据;了解标签外用药情况等。此外,市药监局还将深入到北京市的儿童药品生产企业、儿童用药量比较大的医疗机构等相关单位中,共同推动儿童用药研究与生产,推动首儿所、北京儿童医院等儿童专科医院中的院内制剂“转向”药品,力争惠及更多的孩子。

Beijing administration officials said,This year, the administration's city will start children herbs in research,Master the basic data of the medicine for children in this city;Understand label for external use situation, etc.In addition,City administration will also further to the children's pharmaceutical production enterprise/Children is considered in medical institutions and other related units,To promote children's medicine research and production,Promote the first son/Beijing children's hospital and children's hospitals in the hospital preparation"steering"drug,Strive to benefit more children.

  业内人士表示,由于儿童用药人群少、药物开发周期长、利润低、成本高、药物评价难度大,企业研发生产积极性不足,导致专供儿童用药的剂型较少。儿童药品种类、剂型缺乏,医生不得不在现有剂型的基础上自己想办法;孩子在家中则是由家长酌情定用量,有些家长不会看说明书,有些家长看说明书不认真,导致用药比较随意。

The personage inside course of study says,Because children use less people/Drug development cycle is long/Low profit/High cost/Drug evaluation is difficult,Enterprise development is the production of lack of enthusiasm,For children to use less of the dosage form.Children drug kinds/Dosage form the lack of,The doctor had to existing formulations based on your own trying to;The child in the home is set by the parents take into consideration the dosage,Some parents won't read the instruction,Some parents don't read the instructions carefully,Lead to use more casual.

  记者了解到,目前,国家药监局正加紧开展对儿童药物注册申请加快审评、为儿童药物设立药品市场独占期等政策的研究;积极配合药品定价和招标采购等部门研究制定相应支持和引导政策,鼓励药企研发生产适合儿童使用的药物,确保儿童用药安全。

The reporter understands,At present,National administration is stepping up research on children's drug application to speed up the evaluation/Drugs for children set up drug market monopoly phase and policy research;Actively cooperate with drug pricing and bidding procurement departments formulate corresponding policies to support and guide,Encourage medicine enterprise research and development production suitable for children to use drugs,Ensure that children safe drug use.

  另据介绍,今年市药监局还将进一步加强基本药物生产、经营企业和社区卫生服务中心等监督检查,重点强化基本药物电子监管工作,督促企业落实基本药物所有品种扫描上传,提高扫码率和上传数据准确率。落实基本药物质量标准提升工作,对基本药物中标企业实行异地延伸检查,从源头上保障质量安全。强化基本药物品种全覆盖抽验,开展不同区域风险评估和不良反应监测,提高安全保障水平。不断完善药品追溯系统建设,开展药品流通监管码校验试点工作,加强数据传输的监督、查验,确保追溯信息及时、真实、准确。继续加大产业支持力度,充分挖掘“北京市医药创新促进平台”的功能与作用,深入推进“十病十药”等重点项目建设,提高“京药”国际竞争力。进一步完善药品、医疗器械监管风险评估体系,丰富风险评估数据、完善风险评估方法、升级风险评估系统。

The other according to introducing,This year, the administration's city will also further strengthen basic drug production/Business enterprise and community health service center, supervision and inspection,Focus on strengthening basic drug electronic supervision work,Supervise and urge enterprises to essential drugs all varieties scanning upload,Improve and code rate and upload data accuracy.Carry out basic drug quality standard to improve,On the basic drugs enterprises implement different extension inspection,From the source to ensure quality and safety.Strengthen basic drug varieties collected complete coverage,In different regions of risk assessment and adverse reaction monitoring,To improve the level of security.Constantly improve the construction of drug traceability system,Carry out drug circulation supervision code check pilot work,To strengthen the supervision of the data transmission/inspection,Ensure traceability information timely/real/accurate.Continue to increase the industry support,Full mining"Beijing medical innovation to promote the platform"The function and effect,further"Ten disease ten medicine"The construction of key projects, such as,improve"Beijing medicine"The international competitiveness.To further improve drug/Medical equipment regulatory risk assessment system,Rich risk assessment data/Perfect risk assessment method/Upgrade risk assessment system.

  此外,药监部门今年还将推进保健食品电子监管系统的实际应用,搭建并启动化妆品电子监管系统。全面完成药品安全“百千万”工程建设,在巩固街道(乡镇)药品安全社会管理的基础上,探索开展“药品安全放心区”建设,建立药品安全社会化管理长效机制。(记者贾晓宏)

In addition,Also department this year will also promote health food electronic supervision system of practical application,Set up and start cosmetics electronic supervision system.Completely finished drug safety"One billion"Engineering construction,Streets in consolidating(township)Drug safety on the basis of social management,Exploration in"Drug safe area"construction,Establish drug safety socialization management mechanism.(Reporter JiaXiaoHong)



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