中新网3月15日电 国家食品药品监督管理局今日在其官方网站发布国家基本药物目录(2012年版)相关政策问答。答问指出，2012年版目录分为化学药品和生物制品、中成药、中药饮片三个部分，其中，化学药品和生物制品317种，中成药203种，共计520种。以下是全文：

Beijing, March 15 (xinhua) the state food and drug administration today released on its official website national list of essential medicines(The 2012 version)Relevant policy questions and answers.Answered questions pointed out,2012 version of the directory can be divided into chemical medicines and biological products/Proprietary Chinese medicine/Chinese medicine yinpian three parts,Among them,Chemicals and biological products of 317,203 kinds of proprietary Chinese medicine,A total of 520 species.The following is the full:

　　一、为什么要调整国家基本药物目录？实施国家基本药物目录(2012年版)的意义是什么？ a/Why do you want to adjust the national list of essential medicines?The implementation of the national list of essential medicines(The 2012 version)What is the meaning of?

　　2009年8月，经卫生部、人力资源社会保障部、发展改革委等10部门组成的国家基本药物工作委员会审定，由卫生部发布了2009年版国家基本药物目录(基层部分)(以下简称2009年版目录)。2009年版目录药品的配备使用结合零差率销售政策的实施，对于促进合理用药、减轻群众用药负担、建立基层运行新机制发挥了重要作用。

In August 2009,By the ministry of health/Human resources social security/National development and reform commission and other 10 departments of national essential medicines work committee review and approval,By the ministry of health released the 2009 edition of national basic drugs directory(Basic part of)(Hereinafter referred to as the 2009 version of the directory).2009 version of the directory drugs combined with zero rate of implementation of the sales policy,To promote rational drug use/Ease the burden/Set up grass-roots operation mechanism has played an important role.

　　国家基本药物目录(2012年版)(以下简称2012年版目录)是对2009年版目录的调整和完善。例如，增加了品种数量，优化了目录结构，增加了特殊人群适宜品种和剂型等。这是全面贯彻党的十八大精神的具体实践，将有利于进一步深化医改，巩固基本药物制度；有利于深化公立医院改革，促进医保、医药、医疗“三医”互联互动；有利于保基本、强基层、建机制；有利于常见病、多发病、慢性病特别是重大疾病防治；有利于减轻群众用药负担，满足基本用药；有利于树立正确的导向，促进药品企业优化升级；有利于推动医药科技创新。

National list of essential medicines(The 2012 version)(Hereinafter referred to as the 2012 version of the directory)Is to adjust and perfect the 2009 version of the directory.Such as the,Increase the number of varieties,Optimized the directory structure,Increased the special populations adapted varieties and dosage forms, etc.The concrete practice of fully implement the party's eighteen big spirit,Will be conducive to further deepen the reform,Consolidate the basic drug system;Is conducive to deepening the reform of public hospitals,Promote the health/medicine/medical"3 d"Interconnection and interaction;Is conducive to protect the basic/Strong base/Build mechanism;For common diseases/Frequently-occurring disease/Chronic diseases, especially the major disease prevention and control;To ease the burden,Meet the basic drugs;To set up the correct orientation,Promote upgrading of the pharmaceutical enterprise;Will be conducive to the medical science and technology innovation.

　　二、制定2012年版目录开展了哪些工作？ (2)/For 2012 version of the directory in which to work?

　　根据国务院“十二五”医改规划和2012年医改工作安排，同时按照国家基本药物目录实行动态管理，每3年调整一次的相关规定，2012年初，卫生部着手2012年版目录的制订工作。通过对2009年版目录三年实施情况进行深入调研，总结分析各地药品配备使用情况，对照梳理增补药品，探索规范基本药物剂型、规格的路径和方法，整理积累了大量基础数据。

According to the state council"The 12th five-year"Health planning and health care work in 2012,At the same time in accordance with the national list of essential medicines of dynamic management,The related provisions on adjustment once every three years,At the beginning of 2012,The formulation work of the ministry of health to 2012 version of the directory.Three years through the 2009 version of the directory's conduct in-depth research,Summary analysis around the drug usage,Comparison combing supplement of drugs,To explore basic drug dosage form specification/Specifications of the path and method,Accumulated a large number of basic data.

　　7月上旬，国家基本药物工作委员会召开全体会议，审议通过了工作方案，并建立健全了部门协调工作机制。随后，卫生部组织了3100余名医药和临床专家，对选入目录的基本药物安全性、有效性和经济性进行了研究论证。同时，充分听取和吸收采纳各方面意见，整个目录制定工作平稳，进展顺利。11月下旬，国家基本药物工作委员会再次召开全体会议，审议通过2012年版目录，并及时向国务院医改领导小组汇报。经各部门会签同意，专门向国务院书面报告了制定情况。

Early July,National essential medicines work committee plenary meeting,Review through the work plan,And to establish and perfect the department coordination mechanism.then,The ministry of health has organized more than 3100 MingYiYao and clinical experts,Included in the basic drugs to directory security/Research demonstrates the effectiveness and efficiency.At the same time,Absorbed fully listen to and adopt the Suggestions of all aspects,Entire directory make work smoothly,Going smoothly.In late November,National essential medicines work committee plenary meeting again,Review through the 2012 version of the directory,And promptly report to the reform of the state council leading group.With the approval of the department agree to sign,Dedicated to the written report of the state council.

　　三、2012年版目录有哪些特点？ three/What are the typical features of 2012 version of the directory?

　　2012年版目录分为化学药品和生物制品、中成药、中药饮片三个部分，其中，化学药品和生物制品317种，中成药203种，共计520种。2012年版目录具有以下特点：一是增加了品种数量，能够更好地服务基层医疗卫生机构，推动各级各类医疗卫生机构全面配备、优先使用基本药物。二是优化了结构，补充抗肿瘤和血液病用药等类别，注重与常见病、多发病特别是重大疾病以及妇女、儿童用药的衔接。三是规范了剂型、规格，初步实现标准化。520种药品涉及剂型850余个、规格1400余个，尽管目录品种数量增加，但与2009年版目录307个品种涉及的剂型780余个、规格2600余个相比，数量明显减少，这对于指导基本药物生产流通、招标采购、合理用药、定价报销、全程监管等将具有重要意义。

2012 version of the directory can be divided into chemical medicines and biological products/Proprietary Chinese medicine/Chinese medicine yinpian three parts,Among them,Chemicals and biological products of 317,203 kinds of proprietary Chinese medicine,A total of 520 species.2012 version of the directory has the following characteristics:Number one is to increase the varieties,To better serve grassroots medical and health institutions,Promote comprehensive equipped with all kinds of medical and health institutions at various levels/Priority in use of basic drugs.Second is to optimize the structure,Supplement the antitumor drugs and diseases of the blood and other categories,Pay attention to and common diseases/Frequently-occurring disease especially major disease, as well as women/Children's drugs.Three is normal dosage forms/specifications,Preliminary realize standardization.520 kinds of pharmaceutical formulations involving more than 850/More than 1400 specifications,Although the directory varieties increase in the number,But with the 2009 version of the directory 307 more than 780 varieties of dosage forms/Compared to more than 2600 specifications,Significantly reduce the number,For the guidance of the basic drug production and circulation/Bidding procurement/The rational use of drugs/Pricing for reimbursement/Constantly monitor and so on will have important meaning.

　　2012年版目录充分注重了与其他政策的有效衔接。一是注重与世界卫生组织基本药物示范目录相衔接，化学药品和生物制品数量与现行世界卫生组织推荐的基本药物数量相近，比较好地代表发展中国家的水平。二是注重与医保(新农合)支付能力衔接，确保了基本药物高比例报销。三是注重与常见病、多发病以及妇女、儿童用药相衔接，并继续坚持中西药并重。四是注重与重大疾病保障用药衔接，目录收录了儿童白血病、终末期肾病、血友病等重大疾病治疗药物，基本满足重大疾病临床基本用药需求。

2012 version of the directory to fully focus on the effective connection with other policies.A notice with the world health organization demonstrate basic drugs directory links up,Chemicals and biological products quantity and the current world health organization recommends similar number of essential medicines,Is better to represent the level of developing countries.Second, pay attention to and health care(New farming and)Ability to pay cohesion,Ensure the basic drugs high percentage reimbursement.3 it is to pay attention to and common diseases/Frequently-occurring disease, as well as women/Children's drugs links up,And continue to insist on equal emphasis on Chinese and western medicine.4 it is to pay attention to and major disease to ensure cohesion,Directory includes children leukemia/End-stage renal disease/Major diseases such as hemophilia treatment drugs,Basic meet the demand of major disease clinical basic drugs.

　　四、2012年版目录怎样适应儿童用药需求？ four/What version of the directory to meet the needs of children's drugs in 2012?

　　儿童用药品种少、剂型单一等问题在国内外普遍存在。2012年版目录充实了儿童专用药品、剂型和规格，包括了所有儿童用的国家免疫规划疫苗。目录中可用于儿童的药品近200种，其中，儿童专用剂型、规格70余个，涵盖颗粒剂、口服溶液剂、混悬液、干混悬剂等适宜剂型，一定程度上可以缓解儿童用药不足的需求。但要看到，从根本上解决儿童用药问题仍将是一项长期复杂的系统工程，涉及生产供应、定价报销、合理使用、质量安全等诸多领域，需要多个部门不断加大支持力度，进一步完善儿童用药政策、加强儿童用药临床综合评价、鼓励研发儿童专用药品、加强儿科临床医师、药师队伍建设等配套政策和措施。

Children less drug varieties/Dosage forms such as single problem is common at home and abroad.2012 version of the directory to enrich the child specific medicines/Types and specifications,Includes all children with national immunization programmes.Directory can be used for children's nearly 200 kinds of drugs,Among them,Formulations for children/More than 70 specifications,Cover the granules/Oral solution/Mixed suspension/Dry suspension agent appropriate dosage forms,To some extent, can reduce children's drugs lack of demand.But want to see,Fundamentally solve the problem of children's drugs will still be a long-term complex systems engineering,Involved in production and supply/Pricing for reimbursement/The rational use of/The quality and safety, and many other fields,Multiple departments need to continue to intensify support,We will further improve the children's drugs policy/Strengthen children's drugs clinical comprehensive evaluation/Encourage r&d child specific medicines/Strengthen the pediatric clinician/Pharmacist team construction and other supporting policies and measures.

　　五、保障易短缺基本药物的供应有哪些措施？ five/Ensure easy supply of the basic drug shortages have what measures?

　　建立以基本药物制度为基础的药品供应保障体系是深化医改的重要内容。在基本药物制度实施过程中，对于各地出现部分基本药物短缺或供应不及时的现象和问题，通过建立基本药物制度监测点，加强对制度实施的全程监测，及时掌握各地药品招标采购和配送供应情况，并会同工业和信息化部等部门联合印发了《关于做好传染病类和急救药品类基本药物供应保障工作的意见》(卫办药政发〔2011〕139号)和《关于对用量小临床必需的基本药物品种实行定点生产试点的实施方案》(工信部联消费〔2012〕512号)，建立了部门协调机制，要求各地通过建立短缺药品信息平台、调整优化医疗机构药品库存、加快研究建立常态化短缺药品储备、试点开展短缺药品定点生产、加强生产供应监测和协调等措施，提高短缺药品供应能力，保障临床需求。

Established on the basis of the basic drug system of drug supply security system is an important content of deepening the reform.In the implementation of the basic drug system,For some basic drug shortages or supply not in time all the phenomena and problems,Through the establishment of the basic drug system monitoring,Strengthen the monitoring in the whole process of the system,Grasps the drug bidding and purchasing and distribution around the supply situation,And, in conjunction with the ministry of industry and information technology departments jointly issued[About infectious disease class and performances category basic drug supply security work](Who do drugs ZhengFa [2011] no. 139)and[About small clinical dosage required basic drug varieties designated production pilot implementation plan](Miit consumption [2012] no. 512),Sector coordination mechanism is established,By establishing a shortage of medicine information platform requirements/Adjusting and optimizing medical institutions and drug stocks/To speed up the shortage of research to establish normalized drug reserves/Carry out drug shortage of fixed-point production pilot/Strengthen the production supply monitoring and coordination and other measures,Improve the shortage of drug supply,Ensure clinical needs.

　　建立基本药物供应保障体系是一个系统工程，是一项长期任务，政策性强，涉及面广。基本药物短缺也是个综合性问题，涉及研发、生产、流通、价格、信息等多环节、多领域、多部门，需要发挥政府主导作用和部门协作优势，进一步明确责任，落实分工，合力保障基本药物质量和供应。同时，还要进一步加强国家药物政策研究，扩大综合效果，鼓励地方结合卫生信息化建设加强探索创新，不断完善基本药物采购供应政策。

Establish a basic drug supply security system is a system engineering,Is a long-term task,The policy is strong,A broader.Shortage of essential drugs is also a comprehensive problem,Involved in research and development/The production/circulation/The price/Information, etc/In various fields/Many departments,Need to play a leading role, and government departments,Further clarify responsibility,To carry out the division of labor,Guarantee quality and supply of basic drugs.At the same time,To further strengthen the national drug policy research,Expand comprehensive effect,Encouraging local combining health informatization construction to strengthen exploration innovation,Constantly improve the basic drug procurement supply policy.

　　六、如何进一步完善基本药物招标采购机制？ six/How to further improve the basic mechanism of drug bidding and purchasing?

　　基本药物制度实施以来，各地通过建立和规范基本药物采购机制，大幅降低了药价，减轻了群众基本用药负担，有效保障了基层药品的质量和供应。

Since the implementation of basic drugs system,Around the procurement mechanism through the establishment and standardize the basic drugs,Greatly reduce the price,Reduce the burden of the masses basic drugs,Effective guarantee the quality of the basic drugs and supplies.

　　随着2012年版目录的实施，各地要按照医改“十二五”规划和《关于巩固完善基本药物制度和基层运行新机制的意见》(国办发〔2013〕14号)要求，继续全面贯彻《建立和规范政府办基层医疗卫生机构基本药物采购机制的指导意见》(国办发〔2010〕56号)，认真做好新一轮基本药物采购工作，坚持以省(区、市)为单位网上集中采购，落实招采合一、量价挂钩、双信封制、集中支付、全程监控等制度。对经多次采购价格基本稳定的基本药物试行国家统一定价；对独家品种试行国家统一定价，也可探索以省(区、市)为单位，根据采购数量、区域配送条件等，直接与生产企业议定采购数量和采购价格；对少数基层必需但用量小、市场供应短缺的基本药物，采取招标定点生产等方式确保供应。鼓励各地进一步探索降低基本药物采购价格、保障供应和质量的有效实现方式和途径。

With the implementation of the 2012 version of the directory,Around to according to the health care reform"The 12th five-year"Planning and[Consolidate the perfect system for basic drugs and grass-roots operation mechanism](Countries do hair [2013] no. 14)requirements,Continue to carry out[Establish and standardize the government grass-roots medical institutions essential medicines procurement guidance mechanism](Countries do hair [2010] no. 56),Serious to do a good job of procurement of a new round of basic drugs,Adhere to province(area/The city)Centralized purchasing online for the unit,To carry out the recruit one/Pegged to the quantity and price/Double envelope system/Centralized payment/The entire system of monitoring, etc.By repeated purchasing prices basically stable, the basic drugs for pricing for national unity;The exclusive varieties trial price of national unity,Also can explore to province(area/The city)For the unit,According to purchasing quantity/Regional distribution condition, etc,Directly with the manufacturers agreed purchase quantity and purchase price;For a few basic essential but the amount is small/Market supply of basic drugs,Take the bidding fixed-point production, ensure supply.Encourage further explore around the lower the price of essential medicines procurement/Guarantee the quality of the supply and effective ways and means.

　　在完善“双信封”制方面，在经济技术标评审中，对药品质量、生产企业的服务和信誉等进行全面审查，将企业通过《药品生产质量管理规范(2010年版)》(GMP)认证作为质量评价的重要指标；在商务标评审中，对竞标价格明显偏低的药品进行综合评估，避免恶性竞争。优先采购达到国际水平的仿制药，激励企业提高基本药物质量。

In the perfect"Double envelope"System in terms of,In the economic and technical standard inspection,The drug quality/Production enterprise to conduct a comprehensive review of service and credibility,The enterprise through the[Drug production quality management norms(The 2010 version)](GMP)Certification as an important index of quality evaluation;In the business in the review,Comprehensive evaluation of bid prices significantly lower drug,Avoid vicious competition.Prior purchasing reached the international level of generic drugs,Motivate enterprises to improve the quality of essential drugs.

　　在供应配送方面，基本药物配送原则上由中标生产企业自行委托药品批发企业进行配送或直接配送，并强调做好偏远、交通不便地区的药品配送服务。充分发挥邮政等物流行业服务网络覆盖面广的优势配送基本药物，各地要在符合有关规定的条件下支持相关企业参与药品配送。

In the aspect of supply and distribution,Basic drug distribution in principle by the production enterprise commissioned by pharmaceutical wholesale enterprises in distribution or distribution directly,And stressed that remote/Inaccessible areas of drug delivery.Postal logistics services such as network into full play the advantages of wide distribution of basic drugs,Around in accord with the relevant provisions of the conditions to support the relevant enterprises to participate in drug distribution.

　　在资金支付方面，要求基本药物采购机构对基层医疗卫生机构基本药物货款统一支付，鼓励通过设立省级基本药物采购周转资金等方式优化付款流程，确保货款及时足额支付。同时，要求省级卫生部门加强对基本药物货款支付情况的监督检查，严厉查处拖延付款行为，并向社会公布。

In terms of money payment,Demand basic drugs procurement agencies to grassroots health institutions basic payment unified payment,Encouraging the establishment of essential medicines at the provincial level through the purchasing process optimization of working capital and other payment,Ensure the timely and full specified amount pay payment for goods.At the same time,Asked the provincial health department to strengthen the supervision and inspection of basic drug payment situation,Delay payment behavior is investigated,And publish to the society.

　　鼓励各地探索基本药物价格合理、保障供应和质量的有效实现方式和途径，突出并确保儿童白血病、终末期肾病和肺癌等重大疾病基本用药供应安全和质量安全，做好基本药物和非基本药物采购工作的衔接。

Encourage exploration of essential medicines around the price is reasonable/Guarantee the quality of the supply and effective ways and means,Highlight and ensure children leukemia/End-stage renal disease and lung cancer and other major disease basic drug supply security and the quality and safety,Prepare basic and non basic drugs procurement work of cohesion.

　　七、医疗卫生机构如何配备使用基本药物？ seven/How is equipped with medical institutions use essential medicines?

　　要根据巩固完善基本药物制度相关部署和要求，加快制定适用于各级各类医疗卫生机构的基本药物使用管理办法，修订完善国家基本药物临床应用指南和处方集，积极推动各级各类医疗机构全面配备和优先使用基本药物，加强基本药物使用的培训、考核和监管。

According to consolidate the deployment and requirements related to improve the system of basic drugs,To speed up the formulation is suitable for all kinds of medical and health institutions at various levels of measures for the administration of basic drug use,Revising perfect national essential drugs clinical guidelines and prescription set,Actively promote comprehensive equipped with all kinds of medical institutions at all levels and the priority in use of basic drugs,Strengthen basic training of drug use/The inspection and supervision.

　　政府办基层医疗卫生机构要全部配备和使用基本药物。乡镇卫生院(中心卫生院)、社区卫生服务机构(中心、站)应当严格按照有关规定，依据自身的功能定位、服务范围、机构规模、服务人口和服务能力水平等不同情况，坚持从目录中合理选择配备和使用基本药物并实行零差率销售。配备使用省级人民政府统一确定的增补药品，要合理控制数量，加强规范管理，并严格执行国家基本药物各项政策。要落实2013年全国卫生工作会议要求，加强医疗机构用药管理，明确二、三级医疗机构基本药物的具体使用金额比例。

Government-run primary care health institutions should all equipped with and using the basic medicine.In towns and townships(Central hospitals)/Community health service institutions(center/standing)Shall be in strict accordance with the relevant provisions,According to its own function orientation/Scope of services/Body size/Different situation, such as population and service ability level,Adhere to choose the allocation and use of essential medicines from the directory and execute zero rate of sales.Equipped with a unity of the people's government at the provincial level are used to determine the supplemental drugs,Reasonable control quantity,Strengthen the standard management,All policies and strict enforcement of national essential drugs.To implement the 2013 national work conference on health requirements,Strengthen the medical management of medical institutions,Clear 2/Tertiary medical establishment of basic drugs used specific amount proportion.

　　鼓励非政府办基层医疗卫生机构使用基本药物。在没有政府办基层机构的乡镇和社区，采取政府购买服务的方式落实基本药物制度，以确保每个乡镇、社区都有实施基本药物制度的基层医疗卫生机构。

Encourage non-government basic-level medical health agency use of essential medicines.In the absence of government grass-roots organizations towns and communities,Take the way of government purchase services to carry out the system of basic drugs,In order to ensure each villages and towns/Communities have implemented the basic drug system of grassroots medical institutions.

　　要积极推广国家基本药物临床应用指南和处方集，规范医务人员用药行为，加强医务人员基本药物知识培训，将其作为医务人员竞聘上岗、执业考核的重要内容。充分利用信息系统对医疗卫生机构和医务人员的用药行为进行监管，特别要强化和发挥药学人员在处方审核或点评等临床药学服务工作中的作用，重点增强基层药学专业技术服务能力，对村卫生室开展静脉给药服务要加强监管和指导。对于专科用药，需在按规定取得相应使用资质或在专科医师指导下使用。同时要与抗菌药物临床应用管理工作紧密结合，推行临床路径管理。

To actively promote the national essential drugs clinical guidelines and prescription set,Regulate the behavior of medical personnel use,Strengthen medical personnel essential medicines knowledge training,As a medical staff hired/An important part of the practice examination.Make full use of the information system of medical and health institutions and medical personnel regulation of drug use,Especially to consolidate and exert pharmaceutical personnel in prescription audit or review the role of clinical pharmacy services,Focus on strengthen grassroots medicine professional and technical service capabilities,Intravenous drug delivery services of village clinics must strengthen the supervision and guidance.For specialist medical,Need to be used in in accordance with the provisions, obtain corresponding qualification or in the used under the guidance of specialists.At the same time to work closely with clinical application of antibacterial drugs management,Implementation of clinical pathway management.

　　要加大宣传力度，引导群众转变用药习惯，促进基本药物临床首选、优先使用，提高安全用药、合理用药水平，做到“医疗机构愿意配、医务人员愿意开、人民群众愿意用”。

Should enhance propaganda,Guide the masses change drug habit,Promote clinical choice of essential medicines/Prior to use,Improve the safe drug use/Rational drug use level,Do it"Medical institutions willing to match/Medical personnel are willing to open/The people are willing to use".

　　八、2012年版目录实施后，能否进一步减轻群众用药负担？ eight/2012 version of the directory after implementation,Can further reduce the medicine burden?

　　2012年版目录品种数量的增加，能够更好地满足群众基本用药需求，有利于进一步巩固基本药物制度实施成效。基本药物以省为单位集中采购会增强集中批量采购的优势，有助于形成合理的基本药物采购价格。随着公立医院改革、取消药品加成政策的不断推进，二级以上医疗机构将逐步全面配备、优先使用基本药物，通过规范处方行为，促进合理用药，增加基本药物的使用数量和销售金额，同时提高基本药物报销比例，由患者自己支付的药品费用将进一步减少。

2012 version of the directory an increase in the number of varieties,Better able to meet the demand of the basic drugs,To further consolidate the basic drug system implementation effect.Basic drug centralized purchasing for the unit with the province can enhance the advantage of concentrated mass purchasing,Helps to form the reasonable basic drug procurement price.Along with the reform of public hospitals/Cancel the drugs addition policy to push,Second class above will gradually equipped with comprehensive medical institutions/Priority in use of basic drugs,Through the standard prescription behavior,To promote the rational use of drugs,The increased use of essential medicines quantity and sales amount,At the same time improve the reimbursement ratio of essential medicines,By patients themselves to pay the cost of drugs will further decrease.

　　九、如何进一步规范地方增补药品？ nine/How to further standardize local supplemental drugs?

　　2009年版目录实施以来，各地都以省为单位增补了一定数量的目录外药品，这对于缓解基层医疗卫生机构用药不足的问题起到了积极作用。但同时也存在着一些不规范的增补现象。2012年版目录将地方增补药品中重合度较高的药品纳入遴选范围，把目录调整与规范药品增补结合起来。各地要结合2012年版目录的实施，在今年上半年通过自查和抽查相结合的方式，组织开展增补药品“回头看”，规范和加强增补药品管理，进一步完善增补药品工作方案并报国家基本药物工作委员会办公室备案。

Since the 2009 version of the directory to implement,All units in the provinces supplemented by a number of directories outside of drugs,To ease the problem of shortage of grassroots medical institutions use has played a positive role.But at the same time it still has some non-standard phenomena of supplement.2012 version of the directory to place supplemented drugs high contact ratio of drugs into the selection range,Combine directory to adjust and regulate drug supplementation.Everywhere want to combine the implementation of the 2012 version of the directory,In the first half of this year, through inspection and spot check,Organizations to carry out the supplemental drugs"To look back",Specification and strengthen the management of supplemental drugs,Further supplemented drugs work plan and submitted to the national essential drugs working committee office for record.

　　要坚持以省为单位统一增补，不得将权限下放到市(地)、县(市、区)或基层医疗卫生机构，并从严控制增补数量，使增补药品控制在合理水平，维护国家基本药物目录的主体地位，实现增补的有序、科学、适度，更好地满足群众基本用药需求。

To adhere to province unified supplement for the unit,The authority may not be down on the city(to)/county(The city/area)Or grassroots medical and health institutions,And supplemented quantity controlled strictly,Supplementation of drug control in reasonable level,The subject status of the national list of essential medicines,Implement additions in order/science/moderate,To better meet the demand of the basic drugs.

　　十、2012年版目录与医改相关政策如何衔接？ ten/2012 version of the directory associated with healthcare reform policy how to join?

　　基本药物的理念是世界卫生组织在1977年首次提出的，我国从1979年开始引入“基本药物”的概念。2009年，深化医改将建立基本药物制度作为五项重点改革任务之一，明确了基本药物是适应基本医疗卫生需求，剂型适宜，价格合理，能够保障供应，公众可公平获得的药品。政府举办的基层医疗卫生机构全部配备和使用基本药物，其他各类医疗机构也都必须按规定使用基本药物。国家基本药物制度是对基本药物的遴选、生产、流通、使用、定价、报销、监测评价等环节实施有效管理的制度，与公共卫生、医疗服务、医疗保障体系相衔接。

The concept of essential medicines was first proposed in 1977 by the world health organization,Introduced our country since 1979"Essential medicines"The concept of.In 2009,,Deepening the reform is to set up the basic drug system, as one of the five key reform tasks,Has been clear about the basic drugs is the needs of adapt to basic medical and health care,Dosage form suitable for,The price is reasonable,Able to supply,The public can be equitable access to medicines.The government at the grassroots medical institutions all equipped with and using the basic medicine,Other kinds of medical institutions also must be in accordance with the use of essential medicines.National system for basic drugs is the selection of essential drugs/The production/circulation/use/pricing/reimbursement/Monitoring and evaluation, implementation of effective management system,And public health/Medical services/Links up the medical security system.

　　基本药物制度启动实施以来，国家基本药物目录发挥了基础和龙头的作用。2011年，基本药物制度初步建立，实现了政府办基层医疗卫生机构的全覆盖，形成了“有目录有制度”的格局，并带动了基层管理体制、补偿机制、人事分配、药品供应、价格机制等方面的综合改革，初步建立了维护公益性、调动积极性、保障可持续的基层医疗卫生机构运行新机制。

The basic drug system since its launch,National list of essential medicines based and played a leading role.In 2011,,The basic drug system preliminary established,Realizing a complete coverage of the government-run primary medical and health institutions,To form the"Directory system"The pattern of the,And drive the basic management system/Compensation mechanism/The personnel allocation/Drug supply/The comprehensive reform of the price mechanism, etc,Maintain the public welfare have been established/To mobilize enthusiasm/Ensure sustainable grassroots health institutions operation mechanism.

　　目前，医改已进入深水区，巩固完善基本药物制度和基层运行新机制正处于关键阶段，面临着新的机遇和挑战。要按照“十二五”医改规划部署，以2012年版目录实施为契机，围绕提高基本药物的可及性、安全性、有效性、合理性、可负担性等目标，进一步规范采购配送、完善定价报销等政策，扩大基本药物使用范围，统筹推进基层综合改革，增强基本药物制度惠民效果，并与健全全民基本医保、公立医院改革整体推进、协同发展，实现医保、医药、医疗“三医”互联互动，合力解决群众看病难、看病贵、看好病的问题。

At present,Healthcare reform has entered the deep waters,Consolidate the perfect system for basic drugs and grass-roots operation mechanism is at a critical stage,Faced with new opportunities and challenges.According to"The 12th five-year"Health care reform plan deployment,Version of the directory is carried out in 2012 as an opportunity,Improve the accessibility of basic drugs/security/The effectiveness/The rationality/Affordable, etc,Further standardize procurement and distribution/Improve the pricing policy for reimbursement, etc,Greater use of essential medicines,Promote the comprehensive reform of the overall planning,Strengthen the basic drug system huimin effect,And improve the universal basic health care/Public hospital reform comprehensively/Collaborative development,Implement health care/medicine/medical"3 d"Interconnection and interaction,Joint effort to solve the medical treatment/See a doctor expensive/Optimistic about the disease problems.

　　十一、进一步加强基本药物的质量监管，有哪些具体措施？ eleven/To further enhance the quality of essential drugs,What are the specific measures?

　　国家对基本药物实行全品种覆盖抽查检验。加大重点品种的监督抽验力度。对基本药物定期进行质量抽检，并向社会及时公布抽检结果。优先提高基本药物及高风险药品的质量；全面提高仿制药质量。开展药品安全风险分析和评价，重点加强基本药物、中药注射剂、高风险药品的安全性评价。落实药品生产质量管理规范，加强对高风险品种生产的监管。严格实施药品经营管理规范，探索建立药品经营许可分类、分级的管理模式。推进国家药品电子监管系统建设，完善覆盖全品种、全过程、可追溯的药品电子监管体系。整合信息资源，统一信息标准，提高共享水平，逐步实现国家药品电子监管系统与有关部门以及企业信息化系统对接。建立农村药品监督网。加强和完善基本药物不良反应监测，建立健全药品安全预警和应急处置机制，完善药品召回管理制度，保证用药安全。

The state shall implement a basic drug varieties all cover random inspection.Strengthen the key varieties of proper supervision.Sampling observation of quality of essential medicines on a regular basis,And release the sampling results in a timely manner to the society.Give priority to improve the quality of essential drugs and high-risk drugs;Comprehensively improve the quality of generic drugs.In drug safety risk analysis and evaluation,We will focus on developing essential drugs/Traditional Chinese medicine injections/High-risk drug safety evaluation.Implementation of pharmaceutical production quality management norms,To strengthen the supervision of high-risk varieties production.Strict implementation of the pharmaceutical management specification,To establish drug business license categories/Hierarchical management mode.Promoting the construction of national drug electronic monitoring system,Complete coverage of all varieties/The whole process/The traceability of the pharmaceutical electronic supervision system.Integration of information resources,Unified information standards,Improve the level of Shared,Gradually achieve national drug electronic monitoring system docking with the relevant departments and the enterprise information system.The establishment of rural drug JianDuWang.To strengthen and improve the basic adverse drug reaction monitoring,To establish and perfect drug safety early warning and emergency response mechanism,Perfecting the drug recall management system,Ensure the safety of drug use.

　　十二、如何进一步完善药物政策，提高基本药物可及性、安全性和有效性，促进优质企业可持续发展？ twelve/How to further improve the drug policy,Improve the basic drug accessibility/Safety and effectiveness,The sustainable development of enterprises with high quality?

　　国家药物政策是国家医药卫生政策的重要组成部分，是科学发展观在医药卫生领域的具体实践，是促进国家药物研发、生产、流通和使用的指导性纲领。世界卫生组织1975年提出本国药物政策应涵盖基本药物遴选、药品可负担性、药品筹资机制、药品供应系统、药品监管和质量保证、药物合理使用、人力资源、监测评估和研究等9个方面。其中，基本药物制度是国家药物政策的核心部分。国家药物政策应确保药品首先是基本药物的可获得性、质量安全、合理使用和医药产业的可持续发展。

National drug policy is an important part of national medicine and health care policy,Is the concrete practice of the scientific concept of development in the field of medicine and health care,Is to promote national drug research and development/The production/The circulation and use of instructional programs.The world health organization (who) 1975 national drug policy should include the basic drug selection/Affordable pharmaceuticals/Drug financing mechanisms/Drug supply system/Drug regulatory and quality assurance/Drug rational use of/The human resources/In nine aspects such as the monitoring and evaluation and research.Among them,The basic drug system is a core part of national drug policy.National drug policy should ensure that medicines first is the availability of essential drugs/The quality and safety/Reasonable use and the sustainable development of the pharmaceutical industry.

　　药品领域政策链条长，涉及部门多。为此，我们将通过开展相关研究和定期发布药物政策白皮书等形式，在药物政策领域逐步建立起规范化、制度化的工作机制，形成上下一致、统一协调的国家药物政策。通过完善国家药物政策以及提升药品质量标准等措施，进一步提高基本药物的可及性、安全性、有效性和使用的合理性、支付的可负担性，促进优质企业可持续发展。

Medicine policy chain length,More involved department.To do this,We will carry out relevant research and regularly released drug policy white paper forms,Gradually establish the standardization in the field of drug policy/The working mechanisms of institutionalization,To form a cohesive/Coordinated national drug policy.Through improve the national drug policy and improve drug quality standard,To further improve the accessibility of basic drugs/security/The validity and the rationality of the use/Pay it affordable,The sustainable development of enterprises with high quality.

　　十三、如何保证2012年版目录顺利实施？ thirteen/How to ensure the smooth implementation in 2012 version of the directory?

　　各地要统一认识，落实分工，加强部门之间的沟通协调，认真组织做好2012年版目录实施工作，及时总结基本药物制度实施的成效和经验，进一步深化、细化基本药物制度相关政策措施。坚持正确的舆论导向，积极做好宣传与引导，采取通俗易懂、生动形象的方式，广泛宣传实施基本药物制度的目标、意义和主要措施，争取社会各界和广大群众的理解、支持和参与，提高全民对基本药物的认知度和信赖度，增强群众信心，为巩固完善基本药物制度营造良好的舆论环境。

Around to unified understanding,To carry out the division of labor,Strengthen communication and coordination between departments,Organization to do a good job of 2012 version of the directory to implement in earnest,Timely summary of achievements and experience on the implementation of the basic drug system,Further deepen/Refine the basic drug system related policies and measures.Insist the right opinion,Completes the propaganda and guidance,Take easy to understand/Vivid image of the way,Wide publicity and implementation of basic drugs system goals/Significance and major measures,Strive for the social from all walks of life and the understanding of the broad masses/Support and participate in,Improve the recognition and trust of essential medicines,Enhance the confidence,To consolidate improve the basic drug system create a good public opinion environment.