广东省汕头市人民政府


汕头市人民政府令第29号


　　《汕头经济特区收费许可证管理办法》已经１９９８年１１月２７日汕头市人民政府第十届五次常务会议通过，现予发布，自发布之日起施行。

　　　　　　　　　　　　　　　　　　　　　　　　　　　市长　周日方
　　　　　　　　　　　　　　　　　　　　　　　　一九九九年一月二十三日

　　　　　　　　　　 汕头经济特区收费许可证管理办法



　　第一条　为加强汕头经济特区（以下简称特区）收费管理，规范收费行为，保障合法收费、制止乱收费，维护国家利益和公民、法人及其他组织的合法权益，根据有关法律、法规，结合特区实际，制定本办法。


　　第二条　凡在特区范围内直接从事下列收费活动的单位和个人，均适用本办法：
　　（一）行政性收费：指国家行政机关和依法行使行政管理职权的单位对社会实行特定管理，按照法律、法规规定的收费；
　　（二）事业性收费：指事业单位为社会提供特定服务，按照法律、法规规定的补偿性收费。
　　（三）教育收费：指办学单位或个人（含社会力量办学）为社会提供教育服务，按有关规定的收费，包括基础教育收费、高等教育收费及其他教育收费；
　　（四）医疗收费：指从事医疗服务的单位或个人按有关规定的收费，包括基本医疗服务收费及特需医疗服务收费等；
　　（五）列管的经营服务性收费：指单位或个人提供场所、设施、技术、信息、知识、体力劳动等经营服务，收取的并列入政府定价（含政府指导价）管理的费用。
　　法律、法规另有规定的，从其规定。


　　第三条　市物价局是特区范围内收费许可证的行政主管部门，负责本办法的组织实施。
　　各区物价局按照收费管理权限，负责本辖区内收费许可证的管理工作。
　　各级财政、税务、审计、监察、工商及有关业务主管部门依照各自职责权限，协助物价部门具体实施本办法。


　　第四条　收费许可证是收费单位或个人在特区内取得合法收费资格的证明文件。
　　凡未取得收费许可证的一切单位和个人，均不得从事本办法第二条所列的收费活动。对没有收费许可证从事收费活动的，被收费的单位和个人有权拒付，有权向物价等有关部门举报、报诉。


　　第五条　收费许可证分为行政事业性收费许可证、医疗收费许可证、教育收费许可证、社会力量办学收费许可证和经营服务性收费许可证等五类。
　　收费许可证由省或市物价部门统一印制，其主要内容包括：
　　（一）收费单位名称或收费人姓名、地址；
　　（二）收费性质、项目、范围、标准；
　　（三）批准收费机关及文号；
　　（四）年度审验记事；
　　（五）物价部门认为应明确的其他事项。


　　第六条　收费许可证实行统一管理，分级核发的原则。具体办法由市物价局另行制定。


　　第七条　收费许可证以收费点（有直接收费行为的）为基本领证单位，实行一点一证。
　　收费许可证由基本领证单位向物价部门申领；经济上不实行独立核算的收费点，由其主管部门统一向物价部门申领。


　　第八条　凡申领收费许可证的单位或个人，应向物价部门提交下列文件和资料：
　　（一）收费许可证申请表；
　　（二）批准收费立项、收费标准的有效文件；
　　（三）有确认收费单位或个人合法身份的文书；
　　（四）其他证明其可领取收费许可证的文件、资料。


　　第九条　物价部门应对申领收费许可证的单位或个人的收费资格进行全面审查，并在收到申请之日起１５日内审查完毕，视情况作出如下处理：
　　（一）符合本办法规定的，制发收费许可证，并按规定标准收取工本费；
　　（二）不符合本办法规定的，不予制发收费许可证，并告之理由；
　　（三）提交的有关文件、资料不齐备的，可退还申请单位或个人限期补正；申请单位或个人逾期不补正的，视为未申请。


　　第十条　对新设立的收费点，收费单位或个人应于机构编制等部门批准或工商注册登记之日起３０日内，向物价部门办理申领收费证手续。


　　第十一条　收费单位或个人在收费期间因机构合并、分设、撤销时，应于上述情况发生之日起１５日内，向原发证机关办理变更或注销手续。
　　收费单位或个人改变单位名称、增减收费项目、调整收费标准和范围的，应于依法批准后１５日内，向原发证机关办理变更或换证手续。
　　收费许可证遗失的，原持证单位或个人应于发现遗失之日起１５日内向原发证机关书面报告，并登报声明作废，同时按规定申办补证手续。
　　收费许可证损毁或因客观环境条件造成内容、字迹不清的，原持证单位或个人应于发现之日起１５日内，到原发证机关办理换证或补证手续。


　　第十二条　收费许可证自物价部门核发之日起三年内有效，期满后仍需从事收费活动的，应向原发证机关申换新证。


　　第十三条　收费单位或个人应凭收费许可证向财政或税务部门领购收费票据（法律、法规、规章另有规定的除外）。对无收费许可证的单位和个人，财政、税务部门不予办理领购收费票据手续；新闻、出版、广告等单位不得为其刊播收费广告。


　　第十四条　凡涉及收费许可证的核发、变更、注销、补发、更换等事项，物价部门应在事后将情况及时知会同级财政税务部门。


　　第十五条　收费单位和个人应严格按收费许可证核准的收费项目、范围和标准，使用财政或税务部门统一印制的收费票据进行收费；应将收费许可证在缴费场所的醒目位置悬挂或摆放；对收费许可证未列入的具体收费项目、标准，应汇集成册或列表张榜公布，作为收费许可证的附件供收费对象查询、监督。


　　第十六条　禁止任何单位和个人伪造、涂改、借用或转让收费许可证。


　　第十七条　收费许可证实行年度审验制度。收费单位或个人应在每年第一季度内，持收费许可证、上年度本单位财务决算等资料，到原发证机关办理年度审验手续。收费许可证的年度审验与收费项目及收费标准的年度审验同时进行。收费许可证经审验符合法律、法规及本办法规定的，由发证机关加盖年审专用章后方可继续使用。未经年度审验的收费许可证（不含该年度新核发的收费许可证）一律作废。
　　收费许可证进行年度审验时，收费单位或个人（不含公办高等院校、中专、中技、中小学校、幼儿园、托儿所、医疗等单位）应按规定缴交年审费。
　　物价部门收取的年审费，应纳入同级财政专户，作为预算外资金管理，专款专用，其使用应接受同级财政、审计部门的管理和监督。


　　第十八条　物价部门对核发的收费许可证应建立档案。档案内容应包括：
　　（一）本办法第八条所列的各项文件、资料；
　　（二）收费单位或个人的年度财务决算及其证明材料；
　　（三）收费变动情况和年度审验记事资料；
　　（四）其他有关资料。


　　第十九条　市、区物价部门应对收费许可证制度的实施情况进行监督检查，各收费单位或个人应向检查人员如实提供有关资料，接受检查。


　　第二十条　收费单位和个人违反本办法第四条，第十条、第十一条、第十二条、第十三条、第十五条、第十六条、第十七条规定的，由物价等部门依照《中华人民共和国价格法》及有关法律、法规、规章的规定予以处罚；对单位的负责人和直接责任人，其所在单位或主管部门或同级监察部门可依照《广东省违法收费行为处罚规定》予以行政处分。


　　第二十一条　当事人对行政处罚决定不服的，可依照国家、省有关行政诉讼、行政复议的规定申请复议或提起诉讼；逾期不申请复议或者不起诉又不履行处罚决定的，由作出处罚决定的机关申请人民法院强制执行。


　　第二十二条　物价部门及其工作人员违反本办法，玩忽职守、徇私舞弊、索贿受贿的，由其所在单位或者上级主管部门给予行政处分；情节严重、构成犯罪的，由司法机关依法追究刑事责任。


　　第二十三条　市物价局可根据本办法制定实施细则。


　　第二十四条　各县（市）收费许可证的管理工作，可参照本办法执行。


　　第二十五条　本办法自发布之日起施行。

Commissioner of SFDA


Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration



(SFDA Decree No. 21)

The Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration, adopted at the executive meeting of the State Food and Drug Administration (SFDA) on November 18, 2005, is hereby promulgated and shall go into effect as of the date of promulgation.


Shao Mingli
Commissioner of SFDA
November 18, 2005





Special Review and Approval Procedure for Drug Registration of the State Food and
Drug Administration


Chapter 1 General Provisions

Article 1 This Procedure is formulated for the purpose of effective prevention, timely control and elimination of the hazards of public health emergencies to ensure the health and safety of the public in accordance with the Drug Administration Law of the People’s Republic of China, Law of the People’s Republic of China on the Prevention and Treatment of Infectious Diseases, Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, Regulations on Preparedness for and Response to Emergent Public Health Hazards, and other relevant laws and regulations.

Article 2 The special review and approval procedure for drug registration refers to the procedure and requirements of the State Food and Drug Administration to carry out special review and approval of drugs for handling public heath emergencies under the principle of unified leadership, early involvement, expeditiousness and efficiency, and scientific review and approval, in an effort to approve drugs for the prevention and treatment of public health emergencies as soon as possible under the threat or after the occurrence of public heath emergencies.

Article 3 The State Food and Drug Administration may, according to law, decide to follow the Procedure to conduct special review and approval of drugs for public health emergencies in any of the following circumstances:
(1) Where the President of the People’s Republic of China declares a state of emergency or the State Council decides that certain areas within a province, autonomous region or municipality directly under the Central Government are in a state of emergency;
(2) Where the contingency program for public health emergencies is initiated according to law;
(3) Where the drug reserve department or the health administrative department of the State Council proposes a special review and approval for drugs having existing national drug standard;
(4) Other circumstances applicable to special review and approval.

Article 4 The State Food and Drug Administration is responsible for the review and approval of clinical trials, production and importation of drugs for the prevention and treatment of public health emergencies.

The (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government shall, upon entrustment of the State Food and Drug Administration, be responsible for on-site inspection and sampling of the pilot products of the drugs for the prevention and treatment of public health emergencies.


Chapter 2 Application Acceptance and On-site Inspection

Article 5 Where the special review and approval procedure for drug registration is initiated, the State Food and Drug Administration is responsible for the acceptance of registration applications for drugs for public health emergencies.

Where a drug or a preventive biological product for public health emergencies has not been marketed in China, the applicant shall, before submission of the registration application, provide the State Food and Drug Administration with relevant research and development information.

Article 6 The applicant shall submit a registration application with relevant technical dossier to the State Food and Drug Administration according to the relevant provisions and requirements on administration of drug registration.

The registration application for drug for public health emergencies may be submitted in electronic form.

Article 7 Before submitting an application for registration, the applicant may provide a feasibility assessment application with general information and relevant explanations. The State Food and Drug Administration shall only comment on the scientific rationality and feasibility of the drug project, and respond within 24 hours.

The response to a feasibility assessment application shall be neither deemed as the review and approval opinion nor legally binding on the review and approval result of a registration application.

Article 8 The State Food and Drug Administration shall organize an expert group to evaluate and review the registration application for drug for the prevention and treatment of public health emergencies, make a decision within 24 hours on whether or not to accept the application, and notify the applicant.

Article 9 Where a registration application is accepted, the State Food and Drug Administration shall organize technical review of submitted dossier within 24 hours and at the same time notify the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the applicant is located to conduct an on-site inspection on drug research and development conditions, and organize sampling and testing of pilot products.

The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall, within five days, submit the on-site inspection result and relevant opinion to the State Food and Drug Administration.

Article 10 The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall organize staff from the departments of drug registration, drug safety and inspection, etc. to participate in the on-site inspection.

The National Institute for the Control of Pharmaceutical and Biological Products shall be notified to send staff to participate in the on-site inspection and sampling of preventive biological products.

Article 11 For drugs that have existing national standards for the prevention and treatment of public health emergencies, the State Food and Drug Administration may directly review and approve the drug in accordance with the relevant provisions in Chapter 6 of the Procedure when it deems there is no need for a clinical trial in accordance with law.

Article 12 With respect to the registration application for a specific vaccine, where only the original virus strain used in the manufacturing is changed while the manufacturing processes or quality specifications are maintained, the State Food and Drug Administration shall make a decision on whether or not to grant the approval within three days after verifying the changed strain used in the manufacturing.


Chapter 3 Testing for Registration

Article 13 After receiving the samples taken by the (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government, the drug testing institution shall immediately organize verification of specifications and laboratory testing on the samples.

The drug testing institution shall complete the testing within the time frame for the drug being applied.

Article 14 For a drug applied first time for marketing, the State Food and Drug Administration may, when necessary, make early involvement by appointing the National Institute for the Control of Pharmaceutical and Biological Products to communicate with the applicant prior to testing for registration so as to timely resolve technical problems which may arise in the process of quality specifications verification and laboratory testing.

With respect to preventive biological products used to prevent and control the epidemic of serious infectious diseases, the State Food and Drug Administration may, depending on the situation, allow the testing for registration and the manufacturer’s self-testing to be performed in parallel.

Article 15 After completion of the specifications verification and laboratory testing on a drug, the drug testing institution shall, within two days, issue its verification opinion and submit it along with the drug test report to the State Food and Drug Administration.


Chapter 4 Technical Review

Article 16 The State Food and Drug Administration shall, within 15 days after acceptance of the registration application for drug for the prevention and treatment in public health emergencies, complete the first round of technical review.

Article 17 Where the State Food and Drug Administration considers that additional data are needed, it shall immediately inform the applicant of the content and timeline.

Where the applicant submits the supplementary data within the specified timeline, the State Food and Drug Administration shall complete the technical review within three days, or, depending on the situations, organize another review meeting within five days, and then complete the review report within two days.


Chapter 5 Clinical Trial

Article 18 Where the technical review is completed, the State Food and Drug Administration shall, within three days, complete the administrative examination, make a decision and inform the applicant.

Where the State Food and Drug Administration decides to approve a clinical trial, it shall issue a Drug Clinical Trial Approval. Where it decides not to approve, it shall issue a Disapproval Notice with reasons.

Article 19 Where an applicant obtains a clinical trial approval, it shall conduct the trial strictly following the relevant requirements in the approval document, and comply with the Good Clinical Practice.

Article 20 Drug clinical trials shall be conducted in institutions legally certified for drug clinical trials. If a clinical trial has to be conducted by an institution not yet certified, a special approval by the State Food and Drug Administration should be obtained.

The application for a clinical trial conducted by an institution not yet certified for drug clinical trials may be submitted along with the application for drug registration.

Article 21 The investigator responsible for a drug clinical trial shall, in accordance with the relevant provisions, timely report adverse events occurred in the process of the clinical trial to the State Food and Drug Administration. If no adverse event occurs, the investigator shall collect relevant information and report to the State Food and Drug Administration monthly.

Article 22 The State Food and Drug Administration shall, in accordance with law, supervise and inspect the clinical trials of drugs for public health emergencies.


Chapter 6 Review, Approval and Monitoring of Drug Production

Article 23 The applicant shall, after completion of the drug clinical trials, submit the relevant data to the State Food and Drug Administration in accordance with the Provisions for Drug Registration.

Article 24 The State Food and Drug Administration shall, within 24 hours after receiving data submitted by the applicant, organize technical review, and at the same time notify the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located to conduct the on-site inspection on the drug manufacturing conditions, and organize the sampling and testing of pilot products.

The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall, within five days, submit the result and opinion of the on-site inspection to the State Food and Drug Administration.

Article 25 Any newly-established drug manufacturer or manufacturer with newly-built manufacturing workshops or newly-added dosage forms for production may apply to the State Food and Drug Administration for a certificate of the Good Manufacturing Practice along with the application for drug registration. The State Food and Drug Administration shall, when conducting the drug registration review, immediately carry out an inspection on the Good Manufacturing Practice certification.

Article 26 The drug testing institution shall, after receiving the samples of three batches taken by the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, immediately arrange the testing.

Upon completion of testing, the drug testing institution shall, within two days, complete the test report and submit it to the State Food and Drug Administration.

Article 27 The State Food and Drug Administration shall carry out technical review in accordance with Chapter 4 of the Procedure, and shall, within three days after the completion of the technical review, complete the administrative examination, make a decision and inform the applicant.
Where the State Food and Drug Administration decides to approve the drug, it shall issue the Letter of Approval for Drug Registration, and may grant an approval number for the drug at the same time if the applicant has appropriate manufacturing conditions; if it decides to disapprove the manufacturing, it shall issue a Disapproval Notice with reasons.

Article 28 Where a drug manufacturer or distributor, or a medical and health institution finds any new or serious adverse drug reaction or cluster adverse reaction relating to a specially approved drug for public health emergencies, it shall immediately report the case to the local (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, the health administrative department at the provincial level and the professional institution for adverse drug reactions monitoring.

The professional institution for adverse drug reactions monitoring shall regard drugs specially approved for public health emergencies as critically monitored products, analyze the collected case reports in accordance with the relevant provisions and timely report to the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government and the State Food and Drug Administration.

The State Food and Drug Administration shall reinforce the reevaluation of approved drugs for public health emergencies after they are marketed.


Chapter 7 Supplementary Provisions

Article 29 The measures for special review and approval of the medical devices for public health emergencies shall be separately formulated by the State Food and Drug Administration with reference to the relevant provisions of the Procedure.

Article 30 The Procedure shall go into effect as of the date of promulgation.