4月1日开始，北京市药品安全“黑名单”管理规定实施细则（试行）将正式实施。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，将通过市药品监督管理局官方网站曝光，接受社会监督，并实施重点监管。

On April 1st,The drug safety of Beijing"The blacklist"Management regulations, implementing rules(On a trial basis)Will be officially implemented.Due to a serious violation of drugs/Medical equipment management law/Laws and regulations/Regulations and administrative penalties by operators and responsible for the production of relevant information,Will be sent to you by city drug administration official website exposure,Accept social supervision,And implementation of key regulatory.

　　据了解，细则出台旨在加强药品和医疗器械安全监督管理，规范北京市药品安全“黑名单”管理工作。“黑名单”公布事项主要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责任人员的姓名、职务、身份证号码（隐去后四位号码）、违法事由、行政处罚决定等。有关行政处罚决定生效后十五日内，市民可以在北京市药监局政务网站查询药品安全“黑名单”。

We have learned,Detailed measures to strengthen medicines and medical equipment safety supervision and management,Specification of Beijing drug safety"The blacklist"Management work."The blacklist"The name of the published items mainly include illegal producers or operators/Business address/The names of the legal representative or person in charge and responsible/position/Id card number(After to four number)/The illegal reason/The decision on administrative punishment, etc.Effect on the administrative penalty decision within 15 days after,Citizens can in Beijing drug administration government affairs website and drug safety"The blacklist".

　　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。今后在申办药品、医疗器械相关行政许可事项时，申请人应作出未聘用已纳入药品安全“黑名单”人员或不具有行业禁入情形的书面承诺。市药监局将对照“药品安全‘黑名单’专栏”中的信息进行审查，对申请人具有行业禁入情形的不予受理或者不予许可。此外，药品安全“黑名单”专栏公布的违法生产经营者还将被记入监管档案，并采取增加检查和抽验频次、责令每季度报告质量管理情况等措施，实施重点监管。

Released the expiry of the time limit,"Drug safety‘The blacklist’column"The information in the turn to"Drug safety‘The blacklist’The database",Query for the society.In bidding for the drugs in the future/Medical equipment related to administrative licensing items,The applicant should not hire has been incorporated in the drug safety"The blacklist"Personnel or does not have trade no-go situation written commitment.The city food and drug administration will compare"Drug safety‘The blacklist’column"The information in the review,About the applicant's industry stands situation that will not be accepted or not to grant permission.In addition,Drug safety"The blacklist"Illegal production operators also released by the column will be credited to regulatory file,And to increase inspection and sample frequency/Shall be ordered to quarterly reports, quality management measures,Implement key regulatory.

　　北京市药监局表示，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，发现有违法行为的，可向市药监局投诉举报中心举报。 （记者张然）

Beijing municipal food and drug administration said,Encouraging social organizations or individuals to included in the drug safety"The blacklist"Supervise the units and individuals,Found to have illegal behavior,Can complain to the food and drug administration report reporting center. (The reporter Zhang Ran)