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.





广东省深圳市物价局


深圳市物价局转发省物价局关于印发《广东省游览参观点门票价格管理办法》的通知

（2001年12月14日）


深价〔2001〕87号


　　现将广东省物价局《关于印发〈广东省游览参观点门票价格管理办法〉的通知》（粤价〔2001〕250号）予以转发，结合我市实际，提出以下意见，请一并贯彻执行。
　　一、商业性投资所建游览参观点门票价格实行市场调节价，由经营者自行定价，报政府价格主管部门备案。全国和省级重点文物保护单位、国家级和省级风景名胜区和自然保护区、省和地级市博物馆、与居民日常生活密切相关的城市公园、纪念馆（堂）、展览馆等游览参观点门票价格仍实行政府定价。
　　 二、特区内的游览参观点门票价格备案或调定价，由经营者直接向市价格主管部门申请；宝安、龙岗区内的游览参观点门票价格备案或调定价，由经营者向区价格主管部门申请。
　　三、实行市场调节价的游览参观点制定和调整门票价格，必须在对外公布10个工作日前向政府价格主管部门备案，经备案后的门票价格方可对外公布执行。
　　四、经营者向政府价格主管部门申报门票价格备案时应提供以下材料：
　　（一）申请备案的报告；
　　（二）拟公布的价格文书；
　　（三）定价依据和理由；
　　（四）成本测算材料。
　　五、价格主管部门受理经营者报送的门票价格备案材料时，应当出具回执。
　　价格主管部门发现报送备案材料违反国家有关价格管理政策法规的，应在受理后10个工作日内向申请单位提出，由申请单位进行修改并再次提请备案；10个工作日未提出异议，申请单位即可实施所备案门票价格。
　　六、原政府定价的商业性投资所建游览参观点门票价格视为已备案，今后价格如有变动，经营者应向价格主管部门申请备案。
　　七、实行政府定价的游览参观点申请制定或调整门票价格时，应当向政府价格主管部门提交以下材料：
　　（一）申请调定价报告；
　　（二）定价依据和理由；
　　（三）现行价格和建议制定的价格、调价幅度、调价额；
　　（四）申请单位经营状况、职工人数、成本变化、财务决算报表等。
　　八、经营者必须严格执行国家有关游览参观点价格管理规定，对擅自制定或提高门票价格，以及未按规定备案等价格违法行为，由价格主管部门依法进行查处。
　　九、本通知从2001年12月20日起执行。


广东省游览参观点门票价格管理办法


　　第一条 为规范游览参观点价格行为，维护正常的价格秩序，促进文化及旅游事业健康发展，依据《中华人民共和国价格法》、《国家计委关于印发游览参观点门票价格管理办法的通知》及《广东省经营服务性收费管理规定》，制定本办法。
　　第二条 本办法适用于各类公园、博物馆、纪念馆（堂）、展览馆、文物古迹、自然风景区、旅游风景名胜区等游览参观点门票价格。
　　第三条 各级政府价格主管部门是游览参观点门票价格的主管部门，依法对游览参观点门票价格实施管理。
　　第四条 省人民政府价格主管部门负责全省游览参观点门票价格政策的制定，加强对价格总水平调控。市、县人民政府价格主管部门负责贯彻落实国家和省有关游览参观点门票价格的政策，做好本地区游览参观点门票价格管理工作。
　　第五条 游览参观点门票价格管理，应当坚持既要有利于增加社会效益、环境效益，又要兼顾补偿服务价值的原则，保持价格水平的合理稳定，维护正常的价格秩序。
　　第六条 游览参观点门票价格依其关系社会文化生活和国际国内旅游的重要程度，分别实行政府定价、政府指导价和市场调节价。
　　（一）全国和省级重点文物保护单位、国家级和省级风景名胜区和自然保护区、省和地级市博物馆、与居民日常生活密切相关的城市公园、纪念馆（堂）、展览馆实行政府定价或政府指导价。具体适用范围和定价权限由地级以上市人民政府价格主管部门确定，并报省价格主管部门备案。
　　（二）纯商业性投资所建景观与游乐场所门票价格实行市场调节价，由经营者自主制定价格，并报当地价格主管部门备案。
　　第七条 旅游参观点门票价格的制定，应区别不同情况，实行分类作价，保持合理比价。
　　（一）对保护性开放的重要文物古迹、大型博物馆、重要的风景名胜区和自然保护区等，门票价格应按照有利于景点保护和适度开放的原则核定；
　　（二）对与居民日常生活关系密切的城市公园、纪念馆（堂）、博物馆和展览馆等，门票价格应按照充分体现公益性的原则核定；
　　（三）对一般的参观游览景点以及纯商业性的游览景点（游乐场所），门票价格应按照补偿费用和合理利润的原则确定。
　　第八条 在国内外享有较高声誉的全国重点文物保护单位、国家级风景名胜区和自然保护区等重要游览参观点门票价格有较大调整时，应组织价格听证会，广泛听取意见。
　　第九条 实行政府定价或政府指导价的游览参观点需要调整门票价格时，应由申请调价的单位先征求同级行政主管部门意见，再报政府价格主管部门审批。
　　制定、调整实行政府定价或政府指导价管理的游览参观点门票价格，应报上一级政府价格主管部门备案。
　　第十条 游览参观点门票原则上应实行一票制。
　　游览参观点内确有必须实行重点保护性开放的特殊参观点，需要单独设置门票的，须经当地价格主管部门批准；如为方便游客，将普通门票和特殊参观点门票或相邻的游览参观点门票合并成联票的，联票价格应当低于各种门票价格相加的总和。
　　第十一条 下列情况之一的应实行优惠门票。
　　（一）适宜当地居民日常休闲、锻炼的城市公园，应设置月（季、年）度门票，月（季、年）度门票应当体现价格优惠。提倡更多的城市休闲公园为市民免费开放或供市民晨运。
　　（二）所有游览参观点（含商业性的游览参观点）应对1.4米以下儿童、60岁以上老人实行优惠票价。提倡对 1.1米以下儿童、70岁以上老人实行免费优惠。
　　（三）具有公益性、教育性的游览参观点应对学生实行优惠票价。
　　（四）具有公益性的游览参观点应对现役军人、残疾人实行优惠票价。
　　（五）游览参观点应对旅游团队实行优惠票价。
　　（六）季节性较强的游览参观点，淡季门票价格可下浮优惠。
　　第十二条 游览参观点内举办临时展览原则上免费。对确有观赏价值且投入较大的，游览参观点可以按价格管理权限申报制定临时展览门票价格。
　　第十三条 游览参观点调整门票价格，应提前15天向社会公布；遇有重要节假日（指春节、劳动节、国庆节等）时，应当提前1个月向社会公布。
　　第十四条 游览参观点不得区别中外游客、本地外地游客设置两种门票价格；不得在出售门票的同时强制代收保险费及其他任何费用。
　　游览参观点普通门票、特殊参观点门票、联票及临时展览门票必须一并公示，由游客自愿选择。
　　 第十五条 游览参观点应当严格执行明码标价的规定。游览参观点门票价格应当印制在门票票面的明显位置上，不得用加盖印章形式在票面上标示价格。
　　第十六条 门票价格实行政府定价或政府指导价管理的，各游览参观点应到当地价格主管部门申领《广东省经营服务性收费许可证》，实行亮证收费。
　　第十七条 游览参观点门票价格管理违反本办法的，由政府价格主管部门依据《中华人民共和国价格法》及国家有关法律、法规予以处罚。
　　第十八条 政府价格主管部门违反本办法的，由上级政府价格主管部门予以纠正，并依据国家有关规定给予通报批评。
　　第十九条 本办法由广东省物价局负责解释。
　　第二十条 本办法自2001年11月1日起施行。