中新网10月30日电 据国家发展和改革委员会网站消息，2012年9月4日，发展改革委、人民银行等七部委联合印发实施《关于进一步加强药品安全信用体系建设工作的指导意见》。发展改革委有关机构负责人就相关问题回答记者提问，全文如下：

Beijing, oct. 30, according to the national development and reform commission website news,On September 4, 2012,Development and reform commission/The people's bank and other seven ministries jointly issued by implementation[On further strengthening drug safety credit system construction work instruction opinion].Development and reform commission the relevant authorities to the related question answering questions,Full text is as follows:

问：请简单介绍印发《指导意见》的目的与意义。 ask:Please issued by the simple introduction[Guiding opinions]Purpose and meaning.

答： a: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。考虑到诚信缺失是导致药品领域安全问题产生的主要因素之一，且药品安全信用体系建设又是一项复杂的系统性工程，为更加全面、更加系统地推动解决药品安全领域诚信缺失问题，保障人民群众用药安全有效，我们联合印发了《指导意见》。

Drug safety is the vital interests of the people/The healthy development of the economy and social harmony and stability.Considering the lack of trust is lead to drug field safety problems is one of the main factors,And drug safety credit system construction is a complex systematic engineering,For a more comprehensive/More system to promote solve the lack of credibility of drug safety field,Protecting the people's drug is safe and effective,We jointly issued by the[Guiding opinions].

　　同时，药品安全领域也是我国社会信用体系建设的重点领域之一。加强药品安全信用体系建设是贯彻落实十七届六中全会精神和国务院第176次常务会议部署，促进我国社会信用体系建设的重要举措。

At the same time,Drug safety field is also China's social credit system construction of one of the key fields.Strengthen the drug safety credit system construction is the implementation of the 17 at the sixth plenary session of the state council and the 176th executive meeting of the deployment,Promote the construction of social credit system an important measure.

问：《指导意见》是如何与年初颁布的《国家药品安全“十二五”规划》衔接的？ ask:[Guiding opinions]How issued by the early[The national drug safety"1025"planning]Cohesion of?

答： a:《国家药品安全“十二五”规划》提出，“十二五”时期要结合深化医药卫生体制改革，全面提高药品标准，进一步提高药品质量，完善药品监管体系，规范药品研制、生产、流通和使用，落实药品安全责任，加强技术支撑体系建设，提升药品安全保障能力，降低药品安全风险，确保人民群众用药安全。《指导意见》通过加强药品安全信用体系建设，推动解决药品安全领域诚信缺失问题，保障人民群众用药安全有效，与规划的精神是一致的。

[The national drug safety"1025"planning]Put forward,"1025"According to the period of deepening medical health system reform,Improve the drug standards,Further improve the drug quality,Perfect drug supervision system,Standard drugs development/production/Circulation and use,Carry out drug safety responsibility,Strengthening technical supporting system construction,Ascension drug safety guarantee ability,Lower drug safety risk,To ensure that people's medication safety.[Guiding opinions]By strengthening the drug safety credit system construction,Promote solve the lack of credibility of drug safety field,Protecting the people's drug is safe and effective,And the spirit of the planning is consistent.

　　从《指导意见》的具体内容看，可概括为两方面：一方面，从药品安全各环节着手，通过加强信用建设，降低药品研制、生产、流通和使用等环节的信用风险，如“建立健全药品研制环节信用体系建设”、“建立健全药品企业产品质量信用管理体系”、“完善药品流通体系，健全准入退出机制”等；另一方面，从运行机制建设和保障措施着手，推动建立药品安全信用体系，如“加快药品行业信用信息资源整合”、“建立健全信用分类监管机制”等。这些内容都与《国家药品安全“十二五”规划》做到了较好衔接。

from[Guiding opinions]The specific contents of the watch,Can be summarized as two aspects:On the one hand,From the drug safety aspects,By strengthening the construction of credit,Lower drug development/production/Circulation and use the links such as credit risk,if"Establish and perfect the medicine development link credit system construction"/"Establish and perfect the medicine enterprise product quality credit management system"/"Perfect the medicine circulation system,Improve the access exit mechanism", etc;On the other hand,From the operation mechanism construction and security measures to,Promote the establishment of drug safety credit system,if"To speed up the drugs industry credit information resource integration"/"Setting up and perfecting the credit classified supervision mechanism", etc.These content and[The national drug safety"1025"planning]Do a good connection.

问：《指导意见》共提出十三个方面的工作，如何区分这些工作的轻重缓急？ ask:[Guiding opinions]Put forward a total of 13 aspects,How to distinguish between these work priorities?

答： a:这十三个方面的工作涵盖了药品安全信用体系建设的各个方面，其中的任何一项工作滞后了，都会对药品安全信用体系建设的成效产生较大的负面影响。因此，这十三个方面的工作都十分重要，需要同步开展，全面推进。与此同时，也要注重结合现实工作基础，把握好工作的重点。药品安全信用体系建设涉及几个关键性问题，也是目前的瓶颈问题，主要有三个：一是信息资源整合问题。这是药品安全信用体系建设的基础性、先导性工作。只有加快信用信息资源整合，建立药品安全失信记录档案，才能为实施信用分类监管和失信联合惩戒提供依据。二是分类监管问题。一方面，对药品企业信用进行科学多维分类，实施分类监管，有助于提高监管效率；另一方面，将动态监管信息纳入药品行业信用信息系统和地方信用信息平台，有助于进一步夯实药品安全领域的信用信息化基础。三是失信联合惩戒问题。失信联合惩戒机制是直接作用于药品安全领域各主体信用行为最有效的制度安排。只有实施失信联合惩戒，有效落实药品生产和经营主体责任，使药品安全领域各主体一处失信、寸步难行，药品安全信用体系建设才能真正取得实效。因此，加强药品安全信用体系建设，既要做到全面推进，又要实现信息资源整合、信用分类监管和失信联合惩戒等方面的重点突破。

The 13 aspect work covers the drug safety credit system all aspects of the construction,Any one job the lag,Can drug safety credit system construction of the effectiveness of produce great negative impact.therefore,The 13 aspects of the work is very important,Need synchronous development,Comprehensively promote.meanwhile,Also want to pay attention to combining the reality basis work,Grasp the focus of the work.Drug safety credit system construction, several key problems involved,Is also the bottleneck problem,There are mainly three:One is the information resource integration problem.This is the drug safety credit system construction of the basic/Pilot work.Only by speeding up the credit information resource integration,Establish drug safety break faith record files,Ability to implement credit classified supervision and provide basis for dishonest joint discipline.The second is classified regulation problem.On the one hand,For pharmaceutical enterprise credit for scientific multidimensional classification,Classified supervision,Help to improve the regulation efficiency;On the other hand,The dynamic regulatory information into the pharmaceutical industry credit information system and local credit information platform,Help further compaction in the field of drug safety credit information base.The third is faithless joint disciplinary problems.Dishonest joint disciplinary mechanism is direct role in various fields of drug safety credit behavior main body the most effective system arrangement.Only the implementation of the faithless joint discipline,Effective implement of pharmaceutical production and management main body responsibility,Make drug safety field each subject at a faithless/stuck,Drug safety credit system construction can we truly achieve the effect.therefore,Strengthen the drug safety credit system construction,Not only to do comprehensive propulsion,And to realize information resources integration/Credit classification regulation and faithless joint discipline of the key breakthrough.

问：如何建立和完善药品生产经营企业信用档案？ ask:How to establish and perfect the medicine production management enterprise credit file?

答： a:短期内，我们将启动该领域的征信工作。在规定诚信记录的标识、存放、保护、检索、留存和处置等规范的基础上，发挥社会性征信机构作用，按照强制性征信、重点征信、引导性征信的不同层次，编制年度征集计划，开发征信空间，初步建立药品生产经营企业信用档案。

In the short term,We will start the field of reference work.In the provisions of the credit record identification/storage/protection/retrieval/Retention and disposal as the basis of standard,Play social agency action,In accordance with the mandatory reference/Key reference/Leading reference of different levels,To prepare yearly solicitation planning,Development reference space,Initially established a drug production management enterprise credit files.

　　从长期看，考虑到药品生产经营企业的信用信息由其在药品安全领域的信用信息和在金融、税务、环保、司法等不同部门和领域的信用信息共同构成，我们要在各部门建立完善行业信用信息记录及数据库，各地方形成统一公共信用信息平台，且实现行业内、地区内公共信用信息互联互通的基础上，推动建立更新及时、覆盖全面的药品生产经营企业信用档案。

In the long run,Considering the pharmaceutical production business enterprise credit information from the field of drug safety credit information and in financial/tax/Environmental protection/The judicial and so on the different departments and fields together constitute the credit information,We want to establish a perfect in every department of trade credit information record and database,The local form a unified public credit information platform,In the industry and realize/In the area of public credit information on the basis of interconnection and interflow,Promote the establishment of updated timely/Comprehensive coverage of drug production management enterprise credit files.

问：失信联合惩戒作为药品安全信用体系建设的重要方面，具体将如何实现？ ask:Dishonest joint discipline as drug safety credit system construction of the important aspect,How to realize the will?

答： a:主要有四个方面的考虑：

There are four main considerations:

　　第一，各部门在现有行政处罚措施的基础上，结合监管对象的失信类别和程度，进一步明确对失信行为的行政处罚措施。在此基础上，由各部门依据药品生产经营企业失信记录，对失信主体实施行政监管性联合惩戒。

The first,Each department in the existing administrative punishment on the basis of the measures,Combined with supervision object faithless category and degree,To further clear discreditable behavior of the administrative punishment.On the basis of,By various departments according to the drug production management enterprise break faith record,To break faith subject to implement administrative supervision sex joint discipline.

　　第二，由药品行业协会对失信会员实施行业性惩戒。

The second,The pharmaceutical industry association member to break faith implementation trade retribution.

　　第三，建立“黑名单”制度，在各级新闻媒体和网站上进行披露和曝光。通过失信信息的广泛传播，使失信的药品生产经营企业受到市场性惩戒(市场交易、融资等)和社会性惩戒(社会谴责等)。

The third,To establish"blacklist"system,At all levels in the news media and website for disclosure and exposure.Through the dishonest information spread widely,That dishonest drug production management enterprise is marketability retribution(Market transaction/financing)And social discipline(Condemnation, etc).

　　第四，对药品安全领域的违法失信行为，由司法部门依法追究民事或刑事责任。

The fourth,In the field of drug safety for illegal discreditable behavior,The judicial department shall be investigated for civil or criminal liability.