中新网8月15日电 国家食品药品监管局日前发布《药品安全“黑名单”管理规定(试行)》(以下简称《规定》)，对于因严重违反药品、医疗器械管理法律、法规、规章受到行政处罚的生产经营者及其责任人员的有关信息，将通过政务网站公布，接受社会监督，并实施重点监管。该规定自2012年10月1日起施行。

Beijing, aug. 15 national food and drug supervision bureau released《Drug safety“blacklist”Management regulations(trial)》(Hereinafter referred to as《provisions》)，For a serious breach of drugs、Medical equipment management law、regulations、Rules are subjected to administrative penalty production operator and its responsible persons of relevant information，Will through the government website，Accept social supervision，And the emphasis on the supervision on the implementation。Since 2012 the provisions on October 1,。

　　建立药品安全“黑名单”，是国家食品药品监管局一项积极探索，旨在进一步加强药品和医疗器械安全监督管理，推进诚信体系建设，完善行业禁入和退出机制，督促生产经营者全面履行质量安全责任，增强全社会监督合力，震慑违法行为。

Establish drug safety“blacklist”，Is the national food and drug supervision bureau a positive exploration，Aim to further strengthen drugs and medical devices safety supervision and management，Promote the construction of credit system，Perfect industry stands and exit mechanism，Supervise the production operators to perform comprehensive quality safety responsibility，Enhance the whole society supervision and force，Deter illegal behavior。

　　《规定》明确，符合下列情形之一、受到行政处罚的严重违法生产经营者，应当纳入药品安全“黑名单”：一是生产销售假药、劣药被撤销药品批准证明文件或者被吊销《药品生产许可证》、《药品经营许可证》或《医疗机构制剂许可证》的；二是未取得医疗器械产品注册证书生产医疗器械，或者生产不符合国家标准、行业标准的医疗器械情节严重，或者其他生产、销售不符合法定要求医疗器械造成严重后果，被吊销医疗器械产品注册证书、《医疗器械生产企业许可证》、《医疗器械经营企业许可证》的；三是在申请相关行政许可过程中隐瞒有关情况、提供虚假材料的；四是提供虚假的证明、文件资料样品或者采取其他欺骗、贿赂等不正当手段，取得相关行政许可、批准证明文件或者其他资格的；五是在行政处罚案件查办过程中，伪造或者故意破坏现场，转移、隐匿、伪造或者销毁有关证据资料，以及拒绝、逃避监督检查或者拒绝提供有关情况和资料，擅自动用查封扣押物品的；六是因药品、医疗器械违法犯罪行为受到刑事处罚的；七是其他因违反法定条件、要求生产销售药品、医疗器械，导致发生重大质量安全事件的，或者具有主观故意、情节恶劣、危害严重的药品、医疗器械违法行为。

《provisions》clear，Meet the following circumstances、The administrative punishment by the serious illegal production operators，Shall be incorporated in the drug safety“blacklist”：Is a production and sales of counterfeit drugs、Inferior drugs revoked drug approval documents or be revoked《Pharmaceutical production license》、《Pharmaceutical trading license》or《Preparation of medical institution license》of；The second is without obtaining a product registration certificate for a medical device production medical equipment，Or production does not conform to the state standards、Industry standard of medical devices if the circumstances are serious，Or other production、Sales are not comply with statutory requirements medical equipment cause serious consequence，Be revoked product registration certificate for a medical device、《Medical device manufacturing enterprise license》、《Medical equipment management enterprise licence》of；Three is the administrative licensing application related in the process of the hide、Provides false materials；Four is to provide false proof、The sample documents or by other fraudulent、Bribery and unfair means，Obtain the relevant administrative licensing、Approval documents or other qualified；Five is in the administrative punishment cases in the process of investigation，Forged or intentionally destroy the scene，transfer、hidden、Forge or destroy evidence material，And refused to、Escape supervision and inspection or refuses to provide relevant information and material，The use of detained without authorization of the item；Six for drug、Medical equipment by the illegal crime criminal punishment；Seven other for violation of legal conditions、Request the production and sales of medicine、Medical devices，Causing a major quality and safety of the event，Or has the subjective intent、Plot bad、Harm serious drug、Medical equipment illegal behavior。

　　同时，生产销售假药及生产销售劣药情节严重、受到十年内不得从事药品生产、经营活动处罚的责任人员，也应当纳入药品安全“黑名单”。

At the same time，The production and sales of fake and inferior drugs if the circumstances are serious production and sales、By ten years shall not be engaged in pharmaceutical production、Business activities of the responsible punishment，Also shall be incorporated in the drug safety“blacklist”。

　　《规定》要求省级以上食品药品监管部门在其政务网站主页的醒目位置设置“药品安全‘黑名单’专栏”，并由专人管理、及时更新。国家食品药品监管局将其查办的重大行政处罚案件涉及的生产经营者、责任人员在“药品安全‘黑名单’专栏”中予以公布。公布事项包括违法生产经营者的名称、营业地址、法定代表人或者负责人以及本规定第七条第二款规定的责任人员的姓名、职务、身份证号码(隐去部分号码)、违法事由、行政处罚决定、公布起止日期等信息。公布期限届满，“药品安全‘黑名单’专栏”中的信息转入“药品安全‘黑名单’数据库”，供社会查询。

《provisions》For food and drug supervision departments at or above the provincial level in its government website homepage the conspicuous“Drug safety‘blacklist’column”，And designate personnel management、update。State food and drug supervision bureau will the investigation of major administrative punishment cases involving production operators、Responsible in“Drug safety‘blacklist’column”Shall be promulgated by the。Published matters including illegal production operator's name、Business address、The legal representative or person in charge and the provisions of paragraph 2 of article 7 of the responsibility of the personnel's name、position、Id card number(Implicit to part number)、Illegal reasons、The decision on administrative penalty、Published information such as ending date。Announced the expiry of the time limit，“Drug safety‘blacklist’column”Information into the“Drug safety‘blacklist’database”，For social inquires。

　　《规定》指出，食品药品监管部门在办理药品、医疗器械相关行政许可事项时，应当对照“药品安全‘黑名单’专栏”中的信息进行审查。对“药品安全‘黑名单’专栏”中公布的违法生产经营者，食品药品监管部门应当记入监管档案，并采取增加检查和抽验频次、责令定期报告质量管理情况等措施，实施重点监管。食品药品监管人员违反该规定，滥用职权、徇私舞弊、玩忽职守的，由监察机关或者任免机关依法对其主要负责人、直接负责的主管人员和其他直接责任人员给予处分。

《provisions》Points out that，The food and drug supervision department in deal with drugs、Medical equipment related to the administrative licensing items，Shall control“Drug safety‘blacklist’column”Using the information in the review。to“Drug safety‘blacklist’column”Published in the illegal production operators，The food and drug supervision department supervision shall be recorded in the archives，And take increase inspection and sample frequency、Regular report shall be ordered to quality management measures, etc，Implement the emphasis on the supervision on the。The food and drug supervision personnel who violate the rules，Abuse of power、Engaging in malpractices for personal gain、derelict，By the supervisory organ or the appointment and removal of the authorities according to law over the main person in charge、Persons who are directly in charge and other directly liable persons shall be punished。

　　国家食品药品监管局鼓励社会组织或者个人对列入药品安全‘黑名单’的单位和个人进行监督。各省(区、市)食品药品监管部门可以结合本地实际，制定药品安全“黑名单”管理规定实施细则。

State food and drug supervision bureau encourage social organizations or individuals listed in the drug safety‘blacklist’Units and individuals to supervision。provinces(area、city)The food and drug supervision department can combine local actual，Make drug safety“blacklist”The detailed rules for the implementation of management regulations。