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.
教育部关于推进教师教育信息化建设的意见
教育部
教育部关于推进教师教育信息化建设的意见
(2002年3月1日)
教体艺厅〔2002〕1号
为适应信息化社会的发展要求,以信息化带动教育现代化,促进教师教育跨越式的发展,积极推进教师教育信息化建设是一项紧迫的重要任务。现就"十五"期间推进我国教师教育信息化建设工作,提出以下意见。
一、积极推进教师教育信息化的重要性和紧迫性
信息化是当今世界发展潮流,是国家社会发展的趋势,信息化水平已成为衡量一个国家现代化水平和综合国力的重要指标。积极推进国家信息化是我国国民经济和社会发展的重要战略举措。提高国民的信息素养,培养信息化人才是国家信息化建设的根本,教育信息化是国家信息化建设的重要基础。教师教育信息化既是教育信息化重要组成部分,又是推动教育信息化建设的重要力量。
当前,信息化已经引起中小学的教育思想、观念、内容、方法等方面发生深刻变革。要实现信息技术在中小学逐步普及和应用,建设一支数量足够、质量合格的具有较高信息素养的中小学师资队伍是关键。目前,我国以现有师范院校为主体的教师教育机构,存在着信息基础设施和资源建设薄弱,现代信息技术和教育技术在教育教学中尚未普及,在教师教育中还不能广泛应用现代远程教育和网络教育手段等方面的问题,难以适应中小学信息技术教育发展的需要。因此,教师教育必须加快信息化进程,加大信息化建设力度,为全面提高中小学教师的信息素养奠定坚实的基础。
二、"十五"期间教师教育信息化建设的指导思想、原则、发展目标和措施
"十五"期间教师教育信息化建设的指导思想:以邓小平同志"教育要面向现代化,面向世界,面向未来"重要思想为指导,全面贯彻落实《中共中央国务院关于深化教育改革全面推进素质教育的决定》和《全国教育事业第十个五年计划》,坚持解放思想,因地制宜,开拓创新,与时俱进,注重应用,立足于培养具有创新精神和实践能力的新型中小学师资,全面提高中小学教师队伍的信息素养。
“十五"期间教师教育信息化建设的原则:以教育信息基础设施建设为基础,以信息资源开发为核心,以推进现代信息技术和教育技术的广泛应用为重点,以提高教师教育质量为根本。
"十五"期间教师教育信息化建设的发展目标:
--加快以各级各类师范院校为主体的教师教育机构信息基础设施和资源建设,逐步构建全国教师教育信息化网络教育体系。
--全面推进现代信息技术和教育技术在教师教育中的普及和应用,显著提高中小学教师的信息素养,促进信息技术与学科课程的整合。
--积极促进教师教育教学方法和手段、管理体制和办学方式的改革创新,探索并初步构建信息环境下教师教育的有效模式。
"十五"期间教师教育信息化建设的措施:
加快教师教育信息基础设施建设
--建立教师教育信息化建设标准,规范和推进各级各类师范院校的信息基础设施建设。每所师范院校都要能够与中国教育科研网联接,并结合自身条件,充分利用现代远程教育平台为广大中小学教师提供丰富的教育服务。
--国家鼓励和支持师范大学数字化学习环境的示范性建设。重点支持西部若干所师范大学校园网建设与升级改造工程。依托有条件的师范大学和其他高等学校建设开放式教师教育网络学院。
--配合中小学"校校通"工程的实施,加强各级教师培训机构,特别是县级教师培训机构的信息基础设施建设,增强其为中小学教师开展校本培训和日常教学提供支持与服务的能力。国家将重点支持中西部贫困地区县级教师培训机构信息基础设施建设。
--鼓励和支持东西部地区师范院校之间广泛开展信息化建设的对口支援和相互协作,实现全国教师教育信息化的协同发展。
--继续在师范院校广泛、深入地开展"捐赠电脑助学行动",支持广大农村和贫困地区中小学开展和普及信息技术教育。
加快教师教育信息资源建设
--加强卫星电视和计算机网络等远程教师教育优质资源的研究和开发,建立教师教育信息资源库,开展教师教育远程教育试点,大力发展远程教师教育。
--鼓励和支持通过多种途径和方式加强教师教育信息资源的开发。积极整合各类教师教育信息资源,加强区域性联合,优势互补,实现教师教育各类信息资源的共享。
--要充分利用各种教育信息资源开展多种形式的教师教育改革实验,建设本区域的教师教育网络资源服务中心和服务站点,与当地师范院校和中小学校园网连通,以多种方式为中小学教师继续教育服务。
加强师范院校信息技术和教育技术等专业建设,培养、培训适应普及信息技术教育需要的中小学教师
--有条件的师范院校要开设信息技术教育等专业,逐步扩大招生名额。探索通过双学位、主辅修及加强选修课等形式,培养能基本胜任中小学信息技术教育的师资。引导高师院校信息技术、教育技术等相关专业毕业生到中小学任教。
--加强师范院校信息技术相关专业的建设,提高专业教育水平,增加硕士点和博士点数量。扩大教育技术等硕士研究生的培养规模。
--师范院校要开设信息技术和现代教育技术公共必修课。加强师范院校信息技术相关公共课程教育教学改革和教材建设。
--不断提高师范院校教师的信息素养。5年内,各级各类师范院校的中青年教师,要接受不同程度的信息技术与教育技术的相关培训,学会利用教学软件和通过网络开展教育教学活动和教学研究。形成一批高水平的中小学教师信息技术培训教材和教师指导用书。
--把信息技术教育作为中小学教师继续教育的重要内容之一。通过各种方式对全体中小学教师进行一轮现代信息技术和教育技术培训。要特别加强对骨干教师的信息技术和教育技术的培训。
--加强对中小学信息技术教育专职教师的培训,争取用2至3年时间对中小学信息技术教育骨干教师和网络技术管理人员有针对性的轮训一遍,不断提高他们的业务水平和能力。国家将重点支持中西部地区信息技术教育师资和管理人员的培训。
以科学研究为先导,积极探索和构建现代信息技术环境下教师教育教学与教学管理新模式
--以科学研究为先导,鼓励和支持各级师范院校应用多种信息技术手段改革教师教育,重视教师教育相关技术及标准的研究,鼓励师范院校积极参与教师教育信息化重大技术项目的研究,初步构建具有中国特色的远程教师教育模式。
--推进信息技术在教师教育教学过程中的普遍应用,促进信息技术与教师教育各个专业和学科课程的整合,引导和支持广大教师在教学中广泛运用计算机多媒体技术、信息网络技术和教育技术等先进手段,改进教学工作,提高教学质量。
--积极研究在信息环境下教师教育的运行机制和管理模式,研究各类师范院校信息化教育管理的评价标准,推进教师教育管理的科学化和现代化。
--组织和发动广大师范院校教师和科研人员对教师教育信息化以及师范院校和中小学开展信息技术教育内容、方法、途径和教学模式以及一系列重要课题的研究。
加强领导、管理和评估
--教育部将加强对教师教育信息化建设的指导和协调,切实保证教师教育信息化建设扎实、稳步地实施。各级各类师范院校应成立由主管校领导任组长的教师教育信息化建设领导小组,负责本校信息化建设的组织实施。
--加强教师教育信息化建设的有关政策研究,在引入市场机制、东西部联合与合作、教育资源开发、学位等方面制定相应的配套政策。建立有效的评估体系,制定有关信息化建设的评估标准,通过有效的评估手段促进教师教育信息化的健康发展。
--各地教育行政部门和师范院校要强化信息安全意识。确保教育信息源的内容健康、可靠和安全,防范不良信息的扩散。在吸引外部资金的同时,要把质量和效益放在第一位,淡化商业色彩,坚持教育在信息化建设中的核心地位,避免商业运作中产生失控的现象。
--教育部将组织专家,依据评估标准对各地教师教育信息化的实施情况和重点项目的进展情况进行检查评估。
三、推进"十五"教师教育信息化应注意的几个问题
推进教师教育信息化充满创新和挑战,各级教育行政部门和师范院校既要解放思想,勇于开拓,大胆创新,又要实事求是,扎实稳妥,因地制宜。要注意以下几个问题:
坚持统筹规划,突出重点
--各地教育行政部门根据国家教师教育信息化的总体部署,与本地教育信息化建设统一规划,制订本地区教师教育信息化的实施计划和政策,并具体指导教师教育信息化建设;各级各类师范院校根据国家、省级教育行政部门的要求,立足本校实际,制订具体实施方案,并组织落实。
--推进教师教育信息化是一项系统工程。在实施教师教育信息化过程中要注意突出重点,以点带面。国家将重点支持对教师教育信息化起示范和辐射作用的项目,带动全国教师教育信息化的全面发展和整体水平提高。国家对东部地区和经济发达地区教师教育信息化,主要给予政策支持与宏观指导。
坚持资源共享,协同发展
--要积极开发和合理利用各类教师教育信息资源,在基础设施建设中,要充分利用现代远程教育工程中已有的建设条件,重视卫星数字广播在教师教育信息化中的积极作用。努力实现教师教育信息资源的优化配置和有效利用,最大限度地实现各类信息资源共享,促进教师教育信息化的可持续发展。
--各地教育行政部门要统筹规划当地教师教育信息化建设与中小学普及信息技术教育和"校校通" 工程的实施,提高教育资源的使用效益,相互促进,共同提高。
坚持探索创新,注重应用
--推进教师教育信息化要坚持理论与实践相结合,要突破传统教师教育的时空观,广泛应用现代信息技术和教育技术,积极研究、探索和实践在信息环境下教师教育教学的理论、观念、内容、模式和方法的改革和创新,推动我国教师教育的跨越式发展和教师教育质量的显著提高。
坚持政府引导,因地制宜
--推进教师教育信息化应采取国家、地方和学校三结合的多渠道经费筹措体制。国家教师教育信息化建设专项经费投入将主要用于对教师教育信息化有重要影响的重大项目的支持以及中西部欠发达地区的教师教育信息化建设项目。
--各地在逐渐加大对本地教师教育信息化的投入之外,要适时制定相关政策,鼓励和支持有条件的师范院校依托自身优势,积极探索争取国内外企业及社会各界的支持与合作,引进技术、管理和资金,通过市场运作机制,实施滚动开发,在推进教师教育信息化的同时,形成一批有特色的教育信息产业。保证教师教育信息化建设的良性循环发展。
请按照本意见精神,结合本地区和学校实际,积极推进教师教育信息化工作,并将执行中的问题和意见及时报告我部。