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关于认真贯彻落实《中华人民共和国人口与计划生育法》的意见

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关于认真贯彻落实《中华人民共和国人口与计划生育法》的意见

国家计划生育委员会


关于认真贯彻落实《中华人民共和国人口与计划生育法》的意见

2002年1月11日
国家计生委

           
  《中华人民共和国人口与计划生育法》(以下简称《人口与计划生育法》)经第九届全国人大常委会第二十五次会议审议通过,中华人民共和国主席江泽民颁布第63号令予以公布,于2002年9月1日起施行。现就做好《人口与计划生育法》的贯彻落实工作提出如下意见。
  一、充分认识《人口与计划生育法》颁布实施的重大意义
  《人口与计划生育法》是人口与计划生育工作领域的一部基本法律。它首次以国家法律的形式确立了计划生育基本国策的地位,将具有中国特色综合治理人口问题的成功经验上升为国家的法律制度,把国家推行计划生育的基本方针、政策、制度、措施用法律形式固定下来,为进一步做好人口与计划生育工作,综合治理人口问题,为地方人口与计划生育立法提供了法律依据。它的颁布实施是我国人口与计划生育事业发展史上一个重要的里程碑,是做好人口与计划生育工作最根本的保障和最有力的推动,对于加快人口与计划生育法制建设,全面提高人口与计划生育工作的管理和服务水平,促进人口与经济、社会、资源、环境协调发展和可持续发展必将产生重大而深远的影响。
  《人口与计划生育法》的颁布实施顺应了我国建立社会主义市场经济体制、加强社会主义民主法制建设的客观要求,通过依法规范国家机关及其工作人员人口与计划生育工作的行政行为,明确规定公民实行计划生育的权利和义务,为构建以《宪法》为依据、以《人口与计划生育法》为基本法律、以行政法规、地方法规为主体、以部门规章和地方政府规章相配套的具有中国特色的人口与计划生育法制体系框架奠定了坚实基础,为依法治理人口与计划生育,稳定低生育水平,维护、实现和发展广大群众计划生育、生殖保健的合法权益开辟了广阔的道路。
  《人口与计划生育法》的颁布实施充分体现了江泽民总书记“三个代表”的重要思想,坚持以人为本、以人的全面发展为中心,把依法管理人口与计划生育工作与维护公民的合法权益、约束政府行政行为与规范公民生育行为,以及公民实行计划生育的权利和义务有机统一起来,进一步强化了人民群众在人口与计划生育工作中的主人地位,使人口与计划生育工作更加符合人民群众的根本利益,更有利于稳定低生育水平,调动广大人民群众的参与热情和积极性,为促进家庭幸福、民族繁荣与社会进步,促进人口与计划生育事业稳定、健康、持续发展提供了不竭动力。
  各级领导干部特别是计划生育系统的同志务必从全局和战略的高度充分认识《人口与计划生育法》颁布实施的重大意义,正确理解改革创新与现实工作基础的关系、自我约束与规范群众的关系、国家立法与地方立法的关系,深刻认识在社会主义市场经济条件下,依法管理人口与计划生育工作的极端重要性和迫切性,认识《人口与计划生育法》的颁布实施,既是对公民生育行为的规范,也是对国家机关及其工作人员行政行为的规范,对国家机关及其工作人员依法行政、正确执法、文明执法提出了更高的要求,从而增强法制观念和自我约束意识,尽快改变主要依靠社会制约手段推行计划生育工作的局面,认真履行法定职责,坚决纠正不依法行政、不按法律程序办事、甚至损害育龄群众合法权益的做法,把人口与计划生育工作全面纳入法制的轨道。
  二、准确把握《人口与计划生育法》的主要内容
  准确把握《人口与计划生育法》的主要内容,是贯彻落实好《人口与计划生育法》的关键。
  《人口与计划生育法》共7章47条。
  第一章规定了本法的立法宗旨、目的、依据,开展人口与计划生育工作的基本方针、原则,各级政府、计划生育主管部门及相关部门、社会各方面开展人口与计划生育工作的职责,以及推行计划生育工作应当严格依法行政,计划生育行政部门及其工作人员依法执行公务受法律保护。
  第二章规定了人口发展规划的制定与实施,人口与计划生育事业发展的经费保障及人口与计划生育宣传教育,流动人口计划生育管理的基本原则。
  第三章规定了国家稳定现行生育政策,将现行的生育政策上升到法律的地位,规定了公民实行计划生育的权利与义务,以及计划生育工作过程中的管理、服务措施。
  第四章规定了对实行计划生育公民的奖励、优待,建立有利于计划生育的社会保障制度。
  第五章规定了国家在提高出生人口素质、为公民提供计划生育、生殖保健服务方面应承担的责任,明确了计划生育技术服务机构的法律地位。
  第六章规定了国家机关及其工作人员、技术服务机构及技术服务人员、公民、法人和其他组织违反本法的法律责任。
  第七章规定了授权国务院依据本法制定流动人口计划生育工作的具体管理办法、计划生育技术服务管理的具体办法、社会抚养费的征收管理办法,授权中央军事委员会制定中国人民解放军执行本法的具体办法,以及本法的施行时间。
  《人口与计划生育法》确立了人口与计划生育工作在经济、社会发展和可持续发展中的法律地位;明确了各级政府、计划生育部门及相关部门在人口与计划生育工作中的法定职责,规定了企事业单位、社会团体、村(居)民委员会协助做好人口与计划生育工作的法律责任,以及公民实行计划生育的基本权利和义务;进一步规范了计划生育工作的基本管理制度;充分肯定计划生育工作以宣传教育为主、避孕为主、经常性工作为主的工作方针,坚持以人为本、促进人的全面发展,将实行计划生育与发展经济、消除贫困、提高妇女地位、建设文明幸福家庭有机结合的思路和方法用法律的形式确定下来;提出了建立计划生育的奖励、优待和有利于计划生育的社会保障制度的基本框架;明确了对未履行法定责任的机关、企事业单位、国家机关工作人员,以及破坏计划生育工作行为的法律责任;明确规定了对不符合法律法规规定条件生育子女的公民应当依法缴纳社会抚养费。这些法律规定基本涵括了人口与计划生育工作的最主要、最核心的内容,是做好人口与计划生育工作的最基本的要求。
  准确把握《人口与计划生育法》的主要内容,最重要的是要牢固确立抓紧抓好人口与计划生育工作的观念,依法维护公民合法权益的观念,依法履行计划生育职责、正确执法、文明执法、按法定程序办事的观念,正确理解和运用法律,严格依法行政,避免工作的随意性,把人口与计划生育的各项管理和服务切实纳入法制的轨道,全面加强计划生育法制建设,提高人口与计划生育工作的整体水平,树立良好的国际形象。
  三、迅速掀起学习、宣传和贯彻落实《人口与计划生育法》的热潮
  各地要在党委、政府统一领导下,抓紧在《人口与计划生育法》实施前的一段时间,集中组织协调宣传、司法、新闻等部门,调动社会宣传资源和社会力量,利用报刊、广播、电视、信息网络等媒体,通过多种形式,广泛深入宣传《人口与计划生育法》颁布实施的重大意义,宣传《人口与计划生育法》的基本精神和主要内容,宣传国家法律对做好人口与计划生育工作的有关规定,宣传国家法律规定的公民实行计划生育的权利和义务。在全国城乡掀起学习、宣传和贯彻落实《人口与计划生育法》的热潮。要形成强大的宣传声势和舆论氛围,把《人口与计划生育法》的基本精神和主要内容迅速传播到机关、企事业单位、社会团体、乡村、社区和广大育龄群众,使之家喻户晓,深入人心。要把《人口与计划生育法》的学习、宣传和贯彻作为长期性的工作纳入“四五”普法规划和人口与计划生育法制工作、宣传教育工作“十五”规划的重要内容,切实抓好,抓出成效。
  各级人口与计划生育领导小组要及时组织党政领导、基层干部分期分批认真学习《人口与计划生育法》,全面领会法律的精神实质和有关规定,明确各级党委、政府和相关部门在人口与计划生育工作中的法律责任,带头学法守法用法,自觉以国家法律指导和规范人口与计划生育工作,采取有效措施加大《人口与计划生育法》的贯彻实施力度。
  各级计划生育部门要集中安排一段时间,组织全体干部职工全面、深入学习《人口与计划生育法》,深刻领会法律精神,把握基本原则,明确计划生育部门的法定职责以及公民的权利和义务,熟悉法律的各项具体规定。通过深入学习,增强法制意识,提高依法行政、正确执法、文明执法的自觉性。要组织计划生育干部、协会工作者和志愿者深入乡村、城市社区和育龄夫妇家庭,召开村(居)民大会、组织育龄妇女小组学习、印发宣传资料等多种途径,向广大群众宣讲《人口与计划生育法》,广泛开展法律咨询活动,帮助群众了解他们的权利和义务,了解有关的法律规定,把《人口与计划生育法》的主要精神送进千家万户。
  要组织力量做好《人口与计划生育法》宣传品的制作和发放工作,制作一大批通俗易懂、群众喜闻乐见的宣传品下发到基层,帮助广大干部群众全面了解国家法律的精神实质和主要内容。
  四、切实加强《人口与计划生育法》的干部培训
  各地要按照国家计生委制定的《人口与计划生育法》干部培训计划,通过分级分批培训,在《人口与计划生育法》实施前对分管人口与计划生育工作的党政领导、计划生育干部、计划生育技术服务人员普遍进行一次《人口与计划生育法》、相关法律法规及其配套规章的教育培训,使之全面掌握国家法律的主要精神和基本内容,运用法律指导和推行计划生育工作,在学习法律的过程中增强法律意识,提高自身的法律素质。同时,要对村(居)民委员会干部、育龄妇女小组长、协会会员和志愿者进行法制培训,掌握相关法律法规知识,协助政府做好人口与计划生育工作。
  国家计生委要在2002年上半年完成对省、自治区、直辖市分管领导、省级计生委领导、省级培训师资和对有关部门的相关人员的教育培训工作。各省、自治区、直辖市计生委要在2002年8月底前,按国家计生委的统一要求,有计划地对地(州、市)、县(区、市)分管领导和计划生育干部和师资进行分批轮训,并指导和帮助县(区、市)对乡镇(街道)和村(居)民委员会的分管领导、计划生育干部以及协会工作者进行轮训。
  这次教育培训的时间紧,任务重,要求高,各地务必作为贯彻实施《人口与计划生育法》的一件大事来抓,精心组织,确保质量。为了确保培训质量,国家计生委统编《人口与计划生育法》系列培训教材,并对省级师资进行资格认定,颁发证书。各地要认真做好教育培训计划,选好培训师资和骨干,保证培训时间和参训人员。要切实增强教育培训的针对性,在全面掌握国家法律的主要精神、基本原则和各项法律规定的同时,紧密结合实际,针对计划生育行政执法中出现的问题进行法制教育,切实转变工作方法,改进工作作风,提高依法行政水平。
  五、全面推进人口与计划生育法制建设
  为确保《人口与计划生育法》的贯彻实施,国家计生委将争取国务院尽早颁布《社会抚养费征收管理办法》,各省、自治区、直辖市计生委要配合地方人大在2002年9月1日前做好人口与计划生育地方法规的修订工作。同时,要抓紧制定完善与法律法规相配套的部门规章和地方政府规章,逐步建立和完善人口与计划生育的法制体系。
  各地要认真贯彻国务院颁布的《计划生育技术服务管理条例》,积极争取党委、政府的重视和有关部门的支持,重点解决技术服务机构审批、服务范围确定、技术人员资格认证、免费提供计划生育技术服务等问题。要继续贯彻《流动人口计划生育工作管理办法》,做好即将颁布的《社会抚养费征收管理办法》的贯彻工作。
  各省、自治区、直辖市计生委在配合地方人大做好人口与计划生育地方性法规修订工作中,要依据国家法律的规定,结合实际对人口与计划生育综合管理、生育调节、社会抚养费征收、计划生育技术服务、奖励与社会保障等作出相应规定。要稳定现行生育政策,及时将体现人口与计划生育工作改革发展方向的重要经验和做法,维护公民合法权益、实施综合治理、强化执法监督、建立有利于计划生育的社会保障制度的政策和措施上升为法律规定。
  要继续做好政府规章和各类规范性文件的清理工作,按照《人口与计划生育法》确立的原则和有关规定,修改、完善各级的规范性文件。对违背国家法律精神的,要坚决予以废止。同时,建立健全地方计划生育法规、规章及规范性文件的备案制度。
  要以《人口与计划生育法》的颁布实施为契机,更新观念,与时俱进,加快改革步伐,大力推进人口与计划生育工作综合改革,提高计划生育管理与服务水平。加强计划生育法制建设,提高依法行政水平,把依法行政的基本原则贯彻到计划生育管理与服务的各个环节之中。要继续严格执行“七个不准”的规定,减少和基本杜绝严重侵害公民权益的行为。要全面推行行政执法责任制、行政过错追究制和评议考核制度,健全和规范执法程序,简化审批和办事程序。建立健全执法监督体系,在人口与计划生育工作中,发挥党的监督、人大监督、社会监督、群众监督、司法监督和计划生育行政机关内部的层级监督作用,加强执法检查,推进计划生育政务公开、村务公开,实行民主管理。
  要大力加强计划生育法制队伍建设,加快干部人事制度改革,优化政法干部的知识结构和专业结构。坚持对行政执法人员的岗前培训,实行持证上岗和定期考核制度。认真清理、整顿计划生育行政执法主体,彻底废除靠“临时工”、“小分队”进行行政执法的做法。要切实加强计划生育行政执法队伍的行风建设,努力培养一支有全局观念、群众观念、法制观念,能正确执法、文明执法,作风廉洁、秉公办事、法纪严明的法制工作队伍和行政执法队伍。
  六、切实加强组织领导,确保《人口与计划生育法》的贯彻落实
  各级计生委要把学习、宣传和贯彻落实《人口与计划生育法》切实纳入重要议事日程和对重大事项的督促检查内容,坚持各级计生委主任亲自抓、负总责,认真落实“一把手”责任制,对贯彻落实《人口与计划生育法》的各个环节做出周密部署和安排,制定规划,采取有效措施,对贯彻实施中出现的重大问题认真研究、亲自协调。积极争取党委、人大、政府和有关部门的支持,切实做好学习、宣传和贯彻落实《人口与计划生育法》的各项工作。并将学习、贯彻情况及时报国家计生委。
  各级计生委要进一步加强对人口与计划生育工作的领导,确保计划生育工作顺利开展。要进一步加强基层基础工作,加快后进转化。特别要重点帮助工作基础不够稳固,工作尚有一定难度的地区分析和解决存在的问题和困难,转变工作思路,夯实基础,切实抓紧抓好计划生育工作,为《人口与计划生育法》的实施创造更好的条件。
  各级计生委要协调本系统各业务部门和单位,结合各自业务建章立制,充分发挥计划生育协会等群众团体的作用,抓好《人口与计划生育法》的学习、宣传和贯彻落实。要选配得力干部抓计划生育政法工作,保证学习、宣传和贯彻落实《人口与计划生育法》的必要经费。抓住有利时机推动人口与计划生育工作的改革创新,通过加强法制建设,把人口与计划生育工作提高到一个新的水平。


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Provisions for Drug Advertisement Examination

State Food and Drug Administration,State Administration for Industry and Commerceof the People’s Republic of China


Provisions for Drug Advertisement Examination



(SFDA Decree No. 27)

The Provisions for Drug Advertisement Examination, adopted by the State Food and Drug Administration and the State Administration for Industry and Commerce of the People’s Republic of China, is now issued in the decree sequence number of the State Food and Drug Administration. The Provisions shall go into effect as of the date of May 1, 2007.



Shao Mingli
Commissioner
State Food and Drug Administration

Zhou Bohua
Minister
State Administration for Industry and Commerceof the People’s Republic of China

March 13, 2007





Provisions for Drug Advertisement Examination


Article 1 The Provisions are formulated for the purposes of strengthening regulation on drug advertisements and ensuring the authenticity and legality of drug advertisements in accordance with the Advertisement Law of the People’s Republic of China (hereinafter referred to as Advertisement Law), the Drug Administration Law of the People's Republic of China (hereinafter referred to as Drug Administration Law), the Regulations for the Implementation of Drug Administration Law of the People's Republic of China (hereinafter referred to as Regulations for the Implementation of Drug Administration Law) and other regulations related to supervision on advertisements and drugs.

Article 2 A drug advertisement refers to any advertisement published through various media or forms containing drug name, indications (functions) or other relevant contents, and shall be examined and approved in accordance with the Provisions.

Where only the names of non-prescription drugs (including adopted names and trade names) are publicized or only the names of prescription drugs (including adopted names and trade names) are publicized in professional medical or pharmaceutical journals, the examination is not required.

Article 3 The drug advertisement applied for examination shall be approved provided that it conforms to the following laws, regulations and related provisions:
(1) Advertisement Law;
(2) Drug Administration Law;
(3) Regulations for Implementation of Drug Administration Law;
(4) Criteria for Examining and Publishing Drug Advertisement;
(5) Other provisions of the State on advertisement regulation.

Article 4 The drug regulatory departments of the provinces, autonomous regions or municipalities directly under the Central Government are the drug advertisement examination authorities responsible for examining drug advertisements within their administrative regions. The administrative departments for industry and commerce at or above the county level are supervision and control authorities for drug advertisements.

Article 5 The State Food and Drug Administration shall guide and supervise the examination conducted by drug advertisement examination authorities and punish, in accordance with law, the examination authorities that have violated the Provisions.

Article 6 An applicant for a drug advertisement approval number must be an eligible drug manufacturer or distributor. Where the applicant is a drug distributor, the consent of the drug manufacturer is required.

An applicant may entrust an agent with the application for a drug advertisement approval number.

Article 7 An application for a drug advertisement approval number shall be submitted to the drug advertisement examination authority in the place where the drug manufacturer is located.

An application for an import drug advertisement approval number shall be submitted to the drug advertisement examination authority in the place where the agent of the import drug is located.

Article 8 Where a drug manufacturer or distributor applies for a drug advertisement approval number, it shall submit an Application Form for Drug Advertisement (Appendix 1) with sample manuscript (sample film or sample record) of which the content is consistent with that to be published attached, and an electronic document of drug advertisement application. It shall also submit the following proof documents that are authentic, legal and valid:
(1) Copy of the Business License of the applicant;
(2) Copy of the Drug Manufacturing Certificate or the Drug Supply Certificate of the applicant;
(3) Where the applicant is a drug distributor, the original document proving that the drug manufacturer authorizes the drug distributor to be the applicant shall be submitted;
(4) Where an agent submits an application for a drug advertisement approval number on behalf of the applicant, an original authorization letter given by the applicant to the agent, a copy of business license of the agent and other documents proving the subject’s qualifications shall be submitted;
(5) Copies of the drug approval document (including Import Drug License or Pharmaceutical Product License), copy of approved insert sheet, and label and insert sheet used in practice;
(6) For non-prescription drug advertisement, a copy of registration certificate of non-prescription drug examination or copies of relevant certificates is required;
(7) Where an applicant applies for an import drug advertisement approval number, copies of qualification certificates of the agent of the import drug shall be submitted;
(8) Where the trade name, registered trademark and patent of the drug are involved in an advertisement, copies of the valid certificates and other relevant documents proving the authenticity of the advertisement shall be submitted.

The copy of any approval document prescribed in this Article shall be sealed by the document holder.

Article 9 An advertisement application by an enterprise for a drug shall not be accepted by the drug advertisement examination authorities under any of the following circumstances:
(1) Any of the circumstances under which the application shall be rejected as prescribed in Article 20, Article 22 and Article 23 of the Provisions;
(2) An administrative procedure to withdraw a drug advertisement approval number is in process.

Article 10 After receiving an application for drug advertisement approval number, where the dossier is complete and in conformity with statutory requirements, the drug advertisement examination authority shall issue an Acceptance Notice of Drug Advertisement; where the dossier is incomplete or not conforming to the statutory requirements, one notification on all the content to be supplemented or corrected shall be given to the applicant on the spot or within five working days; if the notification to the applicant is not issued within the timeline, the application is deemed as being accepted upon the date when the dossier is received.

Article 11 Within ten working days upon accepting an application, the drug advertisement examination authority shall check the authenticity, legality and validity of the documents submitted by the applicant, and shall examine the advertisement content in accordance with law. For the drug advertisement in conformity with statutory requirements, a drug advertisement approval number shall be issued; for those not in conformity with statutory requirements, the authority shall make a decision of not issuing a drug advertisement approval number and notify the applicant of the decision with reasons in written form and the applicant’s right to apply for administrative reconsideration or to bring an administrative suit by law.

For approved drug advertisement, the drug advertisement examination authority shall report to the State Food and Drug Administration for records and send the approved Application Form for Drug Advertisement to the authority responsible for advertisement supervision and control at the same level for records. Where there is any problem in the drug advertisement reported to the State Food and Drug Administration for records, the State Food and Drug Administration shall instruct the drug advertisement examination authority to correct it.

The drug regulatory departments shall announce the approved drug advertisement timely.

Article 12 Where a drug advertisement is to be published in the province, autonomous region or municipality directly under the Central Government other than the place where the drug manufacturer and the agent of the import drug are located (hereinafter referred to as “non-local drug advertisement”), it shall, before being published, be submitted for records to the drug advertisement examination authority in the place where the advertisement is to be published.

Article 13 The following materials for non-local drug advertisement shall be submitted for record:
(1) Copy of the Application Form for Drug Advertisement;
(2) Copy of the approved drug insert sheet;
(3) For television or audio broadcast advertisement, it is required to submit the audio tape, compact disc or other medium carrier on which the content is consistent with the approved content.

The copy of any document prescribed in this Article shall be sealed by the document holder.

Article 14 For application for putting non-local drug advertisement on record in accordance with Articles 12 and Article 13 of the Provisions, the drug advertisement examination authority shall, within five working days after accepting the application, put such drug advertisement on record, endorse the word “recorded” on the Application Form for Drug Advertisement, affix the seal specific for drug advertisement examination and send the form to the supervision and control authorities for advertisements at the same level for future reference.

Where the drug advertisement examination authority of a place where a drug advertisement is to be put on record finds that the drug advertisement is not conformed with the relevant provisions, it shall fill in the Opinion on the Record of Drug Advertisement Examination (Appendix 2), submit it to the original drug advertisement examination authority for check, and copy it to the State Food and Drug Administration.

Within five working days upon receiving the Opinion on the Record of Drug Advertisement Examination, the original drug advertisement examination authority shall give its opinions to the drug advertisement examination authority of the place where the drug advertisement is to be put on record. Where no consensus is achieved between the original drug advertisement examination authority and the drug advertisement examination authority of the place where a drug advertisement is to be put on record, the case may be submitted to the State Food and Drug Administration that shall make a final judgment.

Article 15 The valid term of a drug advertisement approval number is one year. It shall become invalid upon expiration.

Article 16 The content of an approved drug advertisement is not allowed to be changed when being published. Where any change to the drug advertisement is needed, a new drug advertisement approval number shall be obtained.

Article 17 Where an advertisement applicant publishes a drug advertisement by itself, it shall keep the original Application Form for Drug Advertisement for two years for future check.

Where an advertisement publisher or advertising operator is authorized by the applicant to publish a drug advertisement, it shall check the original Application Form for Drug Advertisement, publish the advertisement in accordance with the approved content and keep a copy of the Applicant Form for Drug Advertisement for two years for future check.

Article 18 Where there is any of the following circumstances for an approved drug advertisement, the original drug advertisement examination authority shall issue a Notice of Drug Advertisement Re-examination (Appendix 3) and conduct the re-examination. The drug advertisement may continue to be published during the re-examination.

(1) The State Food and Drug Administration finds that the content of the drug advertisement approved by the drug advertisement examination authority is not in conformity with the provisions;
(2) A supervision and control authority for advertisement at or above provincial level makes a re-examination proposal;
(3) Other circumstances where a re-examination is required by a drug advertisement examination authority.

After re-examination, where the drug advertisement is not in conformity to the statutory requirements, the Application Form for Drug Advertisement shall be taken back and the original drug advertisement approval number shall become invalid.

Article 19 Drug advertisement examination authorities shall cancel the drug advertisement approval number in any of the following circumstances:
(1) Where a Drug Manufacturing Certificate or the Drug Supply Certificate is revoked;
(2) Where a drug approval document is withdrawn or cancelled;
(3) Where the State Food and Drug Administration or the drug regulatory department of the province, autonomous region or municipality directly under the Central Government instructs to stop the production, sales and use of the drug.

Article 20 For any alteration to the approved content of a drug advertisement for false propaganda, the drug regulatory departments shall instruct to stop the publication of the advertisement immediately, revoke the drug advertisement approval number, and shall not accept any application for advertisement of the drug within one year.

Article 21 Where any illegal advertisement in which the scope of indications (functions) of the drug is expanded without authorization, the therapeutic effectiveness is exaggerated extremely, or which seriously cheats or misleads the customers, is found, the drug regulatory department at or above the provincial level shall take mandatory administrative measures to suspend the sales of the drug within their administrative area and order the enterprise that illegally publishes the drug advertisement to issue a correction notice in relevant local media.

After the enterprise that illegally publishes the drug advertisement issues a correction notice as required, the drug regulatory department at or above the provincial level shall make a decision on lifting the mandatory administrative measures within 15 working days; where it is necessary to test the drug, the drug regulatory departments shall determine whether to lift the mandatory administrative measures within 15 days as from the day when the test report is issued.

Article 22 Where a drug advertisement application providing false materials is found by the drug advertisement examination authority during the examination, no further application of the enterprise in respect of the advertisement of the drug shall be accepted within one year.

Article 23 Where a drug advertisement with an approval number is found by the drug advertisement examination authority to have provided false materials, such drug advertisement approval number shall be revoked and no further application from the enterprise in respect of the advertisement of the drug shall be accepted within three years.

Article 24 Any drug advertisement, of which the approval number is taken back, cancelled or revoked in accordance with Article 18, Article 19, Article 20 and Article 23 of the Provisions, shall be discontinued for publication immediately; non-local drug advertisement examination authorities shall stop filing the record of the advertisement of the enterprise with the drug advertisement approval number.

Where a drug advertisement examination authority takes back, cancels or withdraws a drug advertisement approval number in accordance with Article 18, Article 19, Article 20 and Article 23 of the Provisions, it shall notify the supervision and control authority for advertisements at the same level within five working days from the day when the administrative decision on the matter is made; the supervision and control authority for advertisements shall handle it in accordance with law.

Article 25 Where a non-local drug advertisement is found not put on record in the drug advertisement examination authority of the place where it is published, the authority shall instruct to file its record within a time limit. If the record is not filed within the time limit, the drug advertisement in the above-mentioned place shall be suspended.

Article 26 The drug regulatory department at or above the county level shall monitor and check the publishing of drug advertisement that has been examined and approved. For any illegal drug advertisements, drug regulatory departments at all levels shall fill in the Notice on the Transfer of Illegal Drug Advertisement (Appendix 4) and transfer it to an supervision and control authority for advertisements at the same level together with such materials as samples of illegal drug advertisement; where the content of approved non-local drug advertisement is altered without permission, the drug advertisement examination authority of the place where the advertisement is published shall advise the original drug advertisement examination authority to revoke its approval number in accordance with Article 92 of the Drug Administration Law and Article 20 of the Provisions.

Article 27 Where an illegal drug advertisement is published and the circumstances are serious, the drug regulatory department of province, autonomous region or municipality directly under the Central Government shall announce the matter to the public and timely report it to the State Food and Drug Administration. The State Food and Drug Administration shall summarize and release the collected information periodically.

Where any false or illegal drug advertisement is published and the circumstances are serious, it shall be announced to the public jointly by the State Administration for Industry and Commerce and the State Food and Drug Administration if necessary.

Article 28 For any drug advertisement published without approval, or the contents published inconsistent with the approved ones, the supervision and control authority for advertisements shall impose a punishment in accordance with Article 43 of the Advertisement Law; where it constitutes false advertisement or misleading propaganda, the supervision and control authorities for advertisements shall impose a punishment in accordance with Article 37 of the Advertisement Law and Article 24 of Anti-Unfair Competitions Law.

In the process of investigation of an illegal drug advertisement, where there is a need to affirm any drug technical information, the supervision and control authority for advertisements shall notify the drug regulatory department at or above the provincial level. The drug regulatory department at or above the provincial level shall give the affirmation result to the supervision and control authorities for advertisements within ten working days after receiving the notification.

Article 29 The staff members that examine and supervise drug advertisements shall be trained in such laws and regulations as the Advertisement Law and the Drug Administration Law. Where the staff members in drug advertisement examination department or in supervision and control authority for drug advertisements neglect their duty, abuse their power, or practice favoritism and commit irregularities, they shall be given an administrative sanction in accordance with law. If a crime is constituted, they shall be investigated for their criminal liabilities in accordance with law.

Article 30 A drug advertisement approval number shall be “X Yao Guang Shen (Shi) No. 0000000000", “X Yao Guang Shen (Sheng) No. 0000000000", “X Yao Guang Shen (Wen) No. 0000000000". “X” is the abbreviation for a province, autonomous region or municipality directly under the Central Government. “0000000000” is a number with ten digits, in which the first six represent year and month of the examination, and the last four represent advertisement approval sequence number. “Shi”, “Sheng” or “Wen” represents certain classification code used in advertising media.

Article 31 These Provisions shall come into force as of May 1, 2007. The Provisions for Drug Advertisement Examination issued by the State Administration for Industry and Commerce and the Ministry of Health (Decree of State Administration for Industry and Commerce No. 25) on March 22, 1995 shall be annulled therefrom.


关于加强机动车交通事故责任强制保险业务核算管理的通知

中国保险监督管理委员会


关于加强机动车交通事故责任强制保险业务核算管理的通知

保监发〔2007〕45号


各中资产险公司,各保监局:

  为了贯彻落实《机动车交通事故责任强制保险条例》(以下简称《条例》),加强交强险业务核算管理,提高数据真实性,维护被保险人合法权益。现就有关事项通知如下:

  一、各具备从事交强险业务资格的保险公司(以下简称公司)必须严格按照《机动车交通事故责任强制保险业务单独核算管理暂行办法》(保监发〔2006〕74号)和《保险公司费用分摊指引》(保监发〔2006〕90号)等的要求,遵循“准确、公平、透明”的基本原则,核算交强险的经营损益、专属资产、专属负债。

  二、各公司必须在2007年8月1日前上报2006年7月1日至2007年6月30日业务年度的交强险专题财务报告。交强险专题财务报告应当由注册会计师审计。专题财务报告的内容按照《机动车交通事故责任强制保险业务单独核算管理暂行办法》的有关规定执行。

  三、中国保监会将依据《条例》对各公司交强险业务情况进行核查,并将各公司交强险专题审计报告及注册会计师名单向社会公布。

  四、各公司必须加强交强险核算管理,严格执行交强险和其他保险业务分开管理、单独核算的要求,提高数据真实性。必须立即对2006年7月1日至今的交强险业务核算情况开展自查并进行数据还原。具体包括:

  (一)交强险已决赔款计入机动车商业保险,或者将机动车商业保险已决赔款计入交强险。

  (二)车险报案案件中涉及交强险的案件未进行分开立案处理。

  (三)车险立案案件中交强险已发生已报告未决赔款未进行分开估损。

  (四)交强险已发生已报告未决赔款估损不足。

  (五)未根据《关于加强机动车交通事故责任强制保险业务责任准备金评估工作有关要求的通知》(保监产险〔2006〕680号)的要求评估交强险业务准备金。

  (六)将交强险专属费用指认到其他保险业务,或将其他保险业务的专属费用指认到交强险业务。

  (七)交强险共同费用比例过高,未根据公司向保监会备案的《费用分摊实施办法》进行共同费用分摊。

  (八)是否以实际可运用资金量的比例将投资收益在交强险和其他保险业务之间进行准确分摊。

  (九)其他影响交强险业务数据真实性的情况。

  五、各公司应总结经验,完善内部控制、改造业务流程、明确岗位职责、完善信息系统、开展专业培训,建立长效机制,确保达到交强险业务的各项核算要求。

  六、各公司必须在2007年6月30日前如实向中国保监会财产保险监管部上报交强险业务核算自查情况、数据还原情况、长效机制建立等情况。对于自查不彻底或自查后仍然存在上述问题的,中国保监会将依法责令其停止接受交强险新业务。

  七、各保监局要加强辖区内公司交强险业务核算的监管,加大对交强险业务数据真实性的检查力度,对于达不到交强险业务核算要求的公司,要依法采取限制业务范围、责令停止接受交强险新业务或吊销经营保险业务许可证等处罚措施。



                    二○○七年六月八日



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