中新网9月20日电 国家发改委日前今日在其官方网站上公布《关于印发进一步加强药品安全信用体系建设工作的指导意见》。意见要求，建立健全药品研制环节信用体系建设，并通过“黑名单”、“不良记录”等方式，使“黑牌”药品生产经营企业及个人“一处失信、处处受限”。 

Beijing September 20, the national development and reform commission has announced today in its official website[About print and distribute further strengthen drug safety credit system construction work instruction opinion].Opinion request,Establish and perfect the medicine development link credit system construction,And through the"blacklist"/"Bad record", etc,make"Black card"Pharmaceutical production business enterprise and individual"One place break faith/Everywhere limited". 

　　以下是意见全文：

The following is the full text opinions:

关于进一步加强药品安全信用体系建设工作的指导意见 On further strengthening drug safety credit system construction work instruction opinion

　　药品安全信用建设是社会信用体系建设的重要组成部分，是新时期国家药品领域规划的发展目标，也是促进药品行业科学发展的重要手段。药品安全事关人民群众日常生活和切身利益，事关经济社会健康发展，事关社会和谐稳定。为了充分发挥各级政府、各相关部门在药品安全信用体系建设中的推动、规范、监督和服务作用，进一步规范药品生产经营秩序，完善诚信社会监督机制，营造行业诚信环境，防范药品安全事故发生，提高药品质量安全水平，促进药品安全信用体系建设，保障人民群众用药安全有效，现提出以下指导意见。

Drug safety credit construction of the social credit system is an important part of the construction of,In the new era national pharmaceutical field planning development goals,Also promote drug industry an important means of scientific development.Drug safety main issue related to People's Daily life and vital interests,Is the healthy development of economy and society,Concerning social harmony and stability.In order to give full play to the government at all levels/The relevant departments in drug safety credit system construction of push/standard/Supervision and service function,Further standardize drug production and operation order,Improve the honesty social supervision mechanism,Build industry of the environment of honesty and credibility,To prevent drug safety accidents,Improve the drug quality safety level,Promote drug safety credit system construction,Protecting the people's drug is safe and effective,This paper proposes the following instruction opinion.

　　

一、建立健全药品研制环节信用体系建设 a/Establish and perfect the medicine development link credit system construction

　　加强药品研制环节备案管理与日常监管工作。强化药品研究申办者的主体责任，以药品研制各相关方／参与人员为征信对象，以监管过程中产生的记录为主要内容进行信用管理，提高研制环节的诚信意识和责任意识。在信用信息累积的基础上，逐步完善信用评级，开展信用分类管理，建立守信受益、失信惩戒的激励与制约机制。根据信用评级，适当调整监督检查的方式、力度，建立信用风险预警与通报制度，

Strengthen the drug development link record management and daily supervision work.Strengthen the drug research bid for the main body of the responsibility,With medicines, the relevant party/participate in personnel as the reference object,To regulate the process of record as the main contents of credit management,Improve development link integrity awareness and sense of responsibility.On the basis of accumulated credit information,Gradually perfect credit rating,Carry out credit classification management,Establish and trustworthy benefit/Disciplinary incentive and restriction mechanism.According to the credit rating,Adjust the supervision and inspection of the way/strength,To establish credit risk early warning and reporting system,

　　健全行业准入与退出机制。加强相关信息的公开，并通过“黑名单”、“不良记录”等方式，发挥市场调节与社会监督作用，促进药品研制过程的规范性，保障药品研究结果的可靠性，促进药品研究良性发展，从源头上保证药品的安全、有效和质量可控。

Improve the industry entry and exit mechanism.To strengthen the public of the relevant information,And through the"blacklist"/"Bad record", etc,Bringing into play the use of market regulation and social supervision function,To promote the standardization of the drug development process,Ensure the reliability of the drug research results,Promote the benign development of the drug research,From the source to ensure drug safety/Effective and the quality is controllable.

　　

二、建立健全药品企业产品质量信用管理体系 two/Establish and perfect the medicine enterprise product quality credit management system

　　推动药品企业完善质量管理体系。严格执行《药品生产质量管理规范》，提高生产环境标准，强化企业质量主体责任，认真实施质量受权人制度，加强员工培训，提高员工素质，实现全员、全过程、全方位参与质量管理，建立和落实质量风险管理、供应商审计、持续稳定性考察等质量管理制度，完善药品安全溯源体系。

Promote pharmaceutical enterprise perfect quality management system.Strict implementation of[The quality control standard for pharmaceutical production],Improve the production environment standard,Strengthening the quality of enterprise's main body responsibility,We will conscientiously implement the quality licensees system,To strength the training to the employees,Improve staff quality,Realize the/process/Comprehensive participate in quality management,Establish and implement quality risk management/Supplier audit/Continuous stability investigation and quality management system,Perfect drug safety traceability system.

　　增强药品生产经营企业诚信意识。健全企业自身信用管理机构，规范企业诚信经营行为，提高企业药品安全生产社会责任，建立药品安全信用风险预警、传递、管控机制和责任追究制度，完善药品质量安全长效管控机制。

Enhance drug production management enterprise integrity awareness.Improve the enterprise's own credit management institution,To standardize enterprise credit management behavior,Improve the drug safety production enterprise social responsibility,Establish drug safety credit risk early warning/transfer/Control mechanism and the accountability system,Perfect quality and safety of drug long-term control mechanism.

　　

三、完善药品流通体系，健全准入退出机制 three/Perfect the medicine circulation system,Improve the access exit mechanism

　　各地区、各部门要结合医药卫生体制改革、城乡建设规划、人口增长与密度和年龄结构变化、药品供应能力等实际，科学合理地布局药品批发零售网点的设置，推动实力强、管理规范、信誉度高的药品流通企业跨区域发展，形成以全国性、区域性骨干企业为主体的遍及城乡的药品流通体系。提高行业准入标准，加强日常监管和考核，建立退出制度，对违反诚信原则、有失信行为记录和违法违规的企业要限期整改，严重的取消经营资格。

regions/Each department according to the medical and health system reform/Urban construction planning/Population growth and density and the age structure change/Drug supply capacity and actual,Scientific and reasonable layout pharmaceutical wholesale and retail network Settings,Promote strength/Management standard/High credibility drugs circulation enterprise trans-regional development,Formation to national/Regional backbone enterprise as the main body of the urban and rural areas throughout the medicine circulation system.Improve the standards for admittance into industries,Strengthen the daily supervision and examination,Establish exit system,In violation of the principle of good faith/A discreditable behavior records and illegal enterprise to rectification within a prescribed time limit,Serious cancel business qualification.

　　

四、建立科学规范的药品招标采购机制 four/To establish a scientific and standardized drug bidding procurement mechanism

　　建立和完善药品行业诚信记录和市场清退制度，对采购过程中提供虚假证明文件，恶意竞标，中标后拒不签定合同，供应质量不达标药品，未按合同规定及时配送供货，向采购机构、医疗机构和个人进行贿赂和变相贿赂的，及时在网上公示并同相关部门实现数据交换，建立失信行为联合惩戒机制。

To establish and perfect the medicine industry credit records and the market system is to repel,In the process of purchasing providing false documents,Malicious bid,After winning the bid refused to sign the contract,Supply quality is not eligible drug,Not according to the contract timely supply and distribution,Procurement agencies to/Medical organizations and individuals to bribes and disguised bribes,Timely in the online public and with relevant departments to realize data exchange,Establish discreditable behavior joint disciplinary mechanism.

　　

五、建立药品临床使用评价制度 five/Establish the clinical use of evaluation system

　　通过研究制定医疗机构临床医生及其从业人员信用评价指标体系，开展医疗机构药品临床应用合理性评估工作，促进临床合理用药。

Through the study and establish a medical institution clinical doctor and its practitioners credit evaluation index system,To carry out medical institutions drug clinical application of rationality assessment work,To facilitate clinical rational drug use.

　　

六、加强药品广告监管，规范药品广告发布活动 six/Strengthen the drug advertising supervision,Standard drug advertising publishing activities

　　完善广告监测体系。加强药品广告监测检查，建立监测预警机制，实施药品广告动态监管，及时发现和制止违法药品广告的发布。完善监管执法联动体系。实施监测、监管、执法联动，各相关部门加强协调配合，及时查处发布违法药品广告的行为，对多次发布严重违法广告的药品生产、经营者采取列入“黑名单”、暂停销售、查办取缔等措施，加大联合公告、联合告诫、联合查处等工作力度。探索建立广告信用监管体系。研究设立广告主、广告经营者、广告发布者的信用评价指标，规范广告发布活动。

Perfect advertising monitoring system.Strengthen the drug advertising monitoring inspection,Establish monitoring early warning mechanism,Implement drug advertising dynamic supervision,Timely find and stop the illegal drug advertisements release.Perfect supervision law enforcement linkage system.Implement monitoring/supervision/Law enforcement linkage,The relevant departments to strengthen coordination and cooperation,And in time by the behavior of illegal drugs advertisement,Of more serious illegal advertisement issued by the pharmaceutical production/Operators to take on"blacklist"/Suspended sales/On investigation measures,Increase the joint announcement/Joint warned/Joint efforts and etc.Explore to establish advertising credit supervision system.The establishment of advertisers/Advertising agents/Advertisement publishers credit evaluation index,Standardize the advertising release activity.

　　

七、加快完善药品安全领域信用制度建设 seven/Speed up improvement of drug safety credit system construction field

　　抓紧研究制定药品安全领域信用制度规范。通过药品安全信用征集制度、信用评价制度、信用披露制度、信用分类监管制度的制定和实施，建立药品企业信用档案，做到真实、准确、可追溯，并规定诚信记录的标识、存放、保护、检索、留存和处置等行业规范。根据药品安全信用评价结果的差别确定不同的监管力度，充分发挥药品安全信用差异对药品企业的奖惩功能，切实提高药品安全信用监管水平，保障人民群众用药安全有效。

To study and establish drug safety credit system specification field.Through the drug safety credit solicitation system/Credit evaluation system/Credit disclosure system/Credit classified supervision system of formulation and implementation,Establish the enterprise credit files,Do real/accurate/The traceability,And provisions of the credit record identification/storage/protection/retrieval/Retention and disposal of the industry standard.According to the drug safety credit evaluation result differences determine different supervision dynamics,Give full play to the drug safety credit differences on pharmaceutical enterprise the rewards and punishment function,In order to improve drug safety credit supervision level,Protecting the people's drug is safe and effective.

　　

八、加快药品行业信用信息资源整合 eight/To speed up the drugs industry credit information resource integration

　　在各部门行业信息管理系统的基础上，完善药品行业信用信息记录，建立药品生产经营企业信用信息档案。各地区要对本地区各部门、药品行业等领域的信用信息进行整合，形成统一平台，实现对药品行业等领域失信行为的协同监管。依托现有国家电子政务网络资源，逐步建立完善部门间与地区间公共信用信息的互通和共享，以确保信用数据全面、及时、准确、公正，促进药品行业信用信息的应用和服务。

In every department industry on the basis of information management system,Perfect drug industry credit information record,Establish drug production management enterprise credit information archives.The governments of all regions shall this area departments/Pharmaceutical industry, and other fields of credit information integration,Form a unified platform,Realize the drug industry, and other fields of discreditable behavior coordinated supervision.Depending on the current national e-government network resources,Gradually establish a perfect between departments and regional public credit information communication and sharing,To ensure that the overall credit data/timely/accurate/justice,To promote the pharmaceutical industry credit information applications and services.

　　

九、建立健全信用分类监管机制 nine/Setting up and perfecting the credit classified supervision mechanism

　　以药品企业静态登记信息和动态监管信息为基础，按照守法诚信度、行业风险度、区域重要度和动态警示度指标体系，对药品企业信用实现科学多维分类，建立守信企业激励机制、警示企业预警机制、失信企业惩戒机制、严重失信企业淘汰机制。对进入被吊销营业执照或取消药品生产许可证的药品企业数据库和一人有限公司数据库的企业及其法定代表人在全国范围内锁定，使“黑牌”药品生产经营企业及个人“一处失信、处处受限”。

Medicine enterprise static registration information and dynamic regulatory information as the foundation,According to the law-abiding integrity/Industry risk level/Regional important degree and dynamic warning degree index system,For pharmaceutical enterprise credit to realize scientific multidimensional classification,Establish and trustworthy enterprise incentive mechanism/Warning enterprise early warning mechanism/Break faith enterprise disciplinary mechanism/Serious break faith enterprise selection mechanism.To enter the business license is revoked or cancelled pharmaceutical production license drug enterprise database and one co., LTD. Database of enterprise and its legal representative in the nationwide lock,make"Black card"Pharmaceutical production business enterprise and individual"One place break faith/Everywhere limited".

　　

十、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 ten/Strictly implement pharmaceutical production and management main body responsibility,Strengthen discreditable behavior of joint discipline

　　在实现行业内、地区内信用信息互联互通的基础上，加快建立药品安全失信记录档案。对人民群众日常生活造成危害、对药品行业健康发展和社会稳定构成影响的药品生产和经营主体的失信行为，不仅要在各级新闻媒体和网站上进行披露和曝光，还要将失信主体列为日常监督、重点监测或抽查的重点，并撤销其已有荣誉称号，依法在行政许可、资质等级评定、评优评先、享受政府补贴、投资项目核准，以及信贷投放等方面予以惩戒，同时实施法律、法规、规章规定的其他限制措施。

In the industry in realization/Area credit information on the basis of interconnection and interflow,To speed up the establishment of drug safety break faith record files.The People's Daily life to cause damage/Pharmaceutical industry to the healthy development and social stability to constitute the influence of drug production and management main body discreditable behavior,At all levels should not only in news media and website for disclosure and exposure,And he will break faith subject as daily supervision/The focus of the key monitoring or selective examination,And revoke its existing honorary title,In accordance with the administrative licensing in/Qualification rating/PingXian assessment/Enjoy government subsidies/Investment projects approved,And credit availability, etc to retribution,At the same time the implementation of legal/regulations/The provisions of rules formulated by the other restrictions.

　　

十一、积极发挥行业协会的推动和自律作用 eleven/To give full play to the industry association to promote and self-discipline function

　　发挥行业协会在企业和政府之间的桥梁纽带作用。指导和鼓励行业协会制定和执行行规行约，支持行业协会承担行业统计、信息服务等行业管理基础性工作，完善医药行业运行监测网络和指标体系，强化行业信息统计和信息发布。引导行业协会加强调查研究，反映行业情况和企业诉求，帮助企业解决实际困难。抓紧出台《药品流通企业诚信经营准则》的行业标准，鼓励行业协会推进诚信体系建设，培育企业质量信用意识，加强行业自律规则的建设。积极开展行业培训，促进企业交流与合作。

Play in industry association between enterprises and government of Bridges.Guide and encourage industry association HangYao guild regulations formulated and implemented,Support industry association bear industry statistics/Information service industry management basic work,Perfect pharmaceutical industry operational monitoring network and index system,Strengthen industrial information statistics and information release.Guide the industry association strengthen investigation and study,Reflect the industry situation and enterprise appeals,Helping the enterprise to solve practical difficulties.Grasp on[Drugs circulation enterprise credit management standards]Industry standard,Encourage industry association promote the construction of credit system,Cultivating enterprise quality credit consciousness,Strengthening the construction of the self-discipline rules.Actively carry out training industry,Promote enterprise exchanges and cooperation.

　　

十二、进一步加强部门之间的协同合作 twelve/To further strengthen the collaboration between departments

　　药品安全是重大民生问题，需要全社会各方面的广泛参与和积极配合。各有关部门要明确各自的工作职责和要求，各司其职，各负其责，密切配合，通力协作，结合各部门的实际，扎扎实实地抓好落实工作。尤其是在信用信息的归集开放、信用信息系统的共建共享等方面，一定要增强大局意识，破除本位观念。在宣传教育、法规制定、执法检查等方面，一定要相互协调，联手行动，提高工作的效率和成效，加快推动药品安全信用体系建设。

Drug safety is significant livelihood of the people question,Need the whole social various aspects widely participation and actively cooperate with.All relevant departments to clarify their respective responsibilities and requirements,Do their own work,individual,Closely cooperate with,together,Combined with the actual departments,One step at a time to pay special attention to carry out the work.Especially in the credit information collection and opening up/Credit information system of sharing, etc,Must strengthen the general situation consciousness,Break standard concept.In the propaganda education/rules/Law enforcement inspection, etc,Must coordinate with each other,To action,Improve work efficiency and effectiveness,To speed up the promote drug safety credit system construction.

　　

十三、开展诚信宣传教育，完善社会监督机制 13/In good faith propaganda education,Perfect social supervision mechanism

　　加强药品行业诚信和职业道德教育。积极开展以“诚信至上，以质取胜”为主题的药品安全诚信承诺活动，广泛开展“诚信经营示范创建”活动，树立一批遵纪守法、诚实守信、管理规范、服务到位，能够积极履行社会责任，自觉接受社会监督的诚信经营典型。公开服务公约、服务项目和投诉举报电话，自觉接受政府、社会和舆论的监督，认真对待公众投诉，做到及时处理与反馈。

Strengthen the drug industry integrity and professional ethics education.Actively carry out to"The good faith is supreme,Quality win"As the theme of the drug safety integrity commitment activities,extensively"The good faith management demonstration to create"activities,Set up a batch of the law/Honest and trustworthy/Management standard/Service in place,To enhance its social responsibility,Consciously accept the supervision of social good faith management typical.Public service convention/Service projects and complaints to report telephone,Consciously accept the government/Social and public opinion supervision,Public complaints seriously,Be a timely treatment and feedback.