Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration
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.
甘肃省邮政条例
甘肃省人大常委会
甘肃省人民代表大会常务委员会公告
（第63号）
《甘肃省邮政条例》已由甘肃省第十一届人民代表大会常务委员会第二十八次会议于2012年8月10日修订通过，现将修订后的《甘肃省邮政条例》公布，自2012年10月1日起施行。
甘肃省人民代表大会常务委员会
2012年8月10日
甘肃省邮政条例
2012年8月10日省十一届人大常委会第二十八次会议修订通过
第一章 总则
第一条 为了保障邮政普遍服务，加强对邮政市场的监督管理，维护邮政通信与信息安全，保护用户合法权益，根据《中华人民共和国邮政法》及有关法律、行政法规，结合本省实际，制定本条例。
第二条 省邮政管理部门负责全省邮政普遍服务和邮政市场的监督管理工作；市(州)邮政管理部门负责本行政区域内邮政普遍服务和邮政市场的监督管理工作。
发展和改革、住房和城乡建设、规划、国土资源、工商行政管理、公安、国家安全、民政、交通运输、进出口检验检疫、海关、铁路、民航等有关部门和单位按照各自职责，做好与邮政有关的工作。
第三条 县级以上人民政府应当将邮政事业纳入当地国民经济和社会发展规划，保障邮政事业与当地经济、社会协调发展，逐步实现邮政普遍服务均等化。
第二章 规划建设
第四条 省邮政管理部门按照统筹安排、合理布局、方便用邮的原则编制全省邮政发展规划；市（州）邮政管理部门按照全省邮政发展规划编制本地区邮政发展规划。
第五条 各级人民政府应当将邮政设施的布局和建设纳入城乡规划，对提供邮政普遍服务的邮政设施建设给予支持，重点扶持农村边远地区邮政设施的建设。
建设城市新区、独立工矿区、开发区、住宅区、旅游区、商业区或者对旧城区进行改建，应当按照城乡规划的要求，同时建设配套的邮政服务网点、邮筒(箱)和邮政报刊亭等邮政设施。
第六条 乡镇应当设置提供邮政普遍服务的邮政所。行政村或者中心村应当设置村邮站（点），负责本村邮件的接收和投递工作。
村邮站（点）建设应当纳入当地新农村建设规划，地方财政给予资金支持，由村委会负责提供所需场地和人员，邮政企业负责提供业务单式、用具和业务方面的支持和指导。
乡镇邮政所和村邮站（点）的选址应当符合土地利用规划和村庄规划的要求，方便群众用邮。
第七条 机关、企业事业单位、住宅小区物业管理单位等应当设置接收邮件的场所，并为邮政企业投递邮件提供便利。
新建居民小区、居民楼，建设单位应当按照国家规定的标准将邮政信报箱群建设纳入建筑设计范围，并在地面首层设置信报箱群，所需费用计入建设成本。未设置信报箱群或者设置的信报箱群未达到国家标准的，相关部门不予验收。
已建成的居民小区或者居民楼未设置信报箱群的，由产权所有者、管理者负责设置或者委托邮政企业设置，所需费用由产权所有者协商解决。
第八条 因城乡建设需要，征收邮政场所、拆迁邮筒（箱）时，应当与当地邮政企业协商，在方便用户、保证邮政工作正常进行和不降低服务标准的情况下，由征收单位或者建设单位将邮政设施迁移或者另建，所需费用由征收、拆迁单位依法承担。
第三章 社会扶持
第九条 邮政企业根据社会需要和城市规划要求，经批准在公共场所设置邮筒(箱)、邮政报刊亭等公用设施，免交城市道路占用费等相关费用，有关部门应当在选址、用地、供电等方面给予支持。
第十条 非营利性邮政设施建设用地，经县级以上人民政府批准，可以以划拨方式取得土地使用权。依法取得的划拨土地必须用于建设非营利性邮政设施，不得改变土地用途。
前款所称非营利性邮政设施，包括邮件处理中心、邮政支局（所），邮政运输、物流配送中心，邮件转运站，国际邮件互换局、交换站，集装容器（邮袋、报皮）维护调配处理场。
第十一条 带有邮政专用标志的普遍服务运邮车辆经交通运输行政主管部门核定，免办道路运输证；在执行邮件运递任务时免收停车费；通过收费路段时通行费予以优惠，具体优惠数额由省交通运输行政主管部门按照省政府确定的标准执行。
带有邮政专用标志的普遍服务运邮车辆需要经过禁行路线、路段或者在禁止停车地段停车的，经公安交通管理部门同意，在不影响交通安全的前提下，可以通行或者临时停车；进出港口和通过检查站时，应当优先放行；发生交通事故时，公安机关应当迅速通知相关企业，并协助保护邮件安全。
第十二条 快递企业运递快件的专用车辆，需要经过禁行路段或者在禁止停车地段停车的，经公安交通管理部门同意，在不影响交通安全的前提下，可以通行或者临时停车。
第十三条 工商行政管理部门应当按照邮政管理部门审核的市(州)县邮政企业及所属分支机构网点表册，统一办理年检手续。
第十四条 工商、税务、民航、铁路、海关等相关部门应当对快递企业发展给予必要的支持。
第四章 普遍服务
第十五条 邮政企业应当根据国家制定的普遍服务标准提供邮政普遍服务。
第十六条 邮政企业应当在营业场所的显著位置公示服务种类、营业时间、资费标准、禁限寄物品目录、邮件和汇款的查询及损失赔偿办法，并提供必要的服务用品(具)。
第十七条 邮政企业在城市每周的营业时间应当不少于六天，投递邮件每天至少一次；在乡、镇人民政府所在地每周的营业时间应当不少于五天，投递邮件每周至少五次。
邮政营业网点调整营业时间时，应当提前五个工作日发布公告。
第十八条 具备通邮条件的住宅或者单位，邮政企业应当自住户和单位办理邮件投递手续之日起十五个工作日内通邮。
尚不具备通邮条件的地段、单位或者个人的邮件、报刊，投交双方可商定投交点，也可设立邮件代投点，统一接收邮件。未设置收发室的居民小区、未设置信报箱或者信报箱不能使用的居民楼房，社区委员会或者其物业管理单位应当为邮政企业投递服务提供必要协助或者代收服务。
第十九条 用户交寄信件时，应当使用符合国家标准的信封，并正确填写收件人的姓名、地址和邮政编码。地名和门牌号码发生变更的，民政部门和公安部门应当及时向社会公布并通知邮政企业，邮政企业应当根据变更后的地名和门牌号码进行投递。
第二十条 邮政企业及其工作人员不得有下列行为：
(一)泄露国家机密；
(二)违反国家规定，不执行收寄验视制度、收寄禁止寄递或者限制寄递的物品；
(三)擅自变更邮政普遍服务收费标准或者增加收费项目，强迫、误导用户使用高资费邮政业务或者搭售商品；
(四)无故拒绝、拖延、中断邮政业务；
(五)违法向他人提供用户使用邮政服务的信息；
(六)私拆、隐匿、毁弃、盗窃邮件，贪污、冒领用户款物；
(七)出租、出借带有邮政专用标志的车辆或者利用带有邮政专用标志的车辆从事邮件运递以外的活动；
(八)转让、出租、出借邮政专用用品(具)；
(九)法律、法规禁止的其他行为。
第五章 快递业务
第二十一条 快递企业应当根据国家制定的快递服务标准提供快递服务。
第二十二条 经营快递业务应当依法取得经营许可，并按照许可的经营范围、地域范围提供快递服务。未经许可，任何单位和个人不得经营快递业务。
省邮政管理部门应当向社会公布快递业务经营许可的相关信息。
第二十三条 快递企业设立、撤销或者分立、合并分支机构的，应当向邮政管理部门备案。
快递企业停止经营快递业务的，应当书面告知邮政管理部门，交回快递业务经营许可证，并对尚未投递的快件按照邮政管理部门的规定妥善处理。
第二十四条 快递企业收取快件时，应当在快递运单详细填写快件的重量、资费等信息，并在显著位置注明时限、保价及赔偿条款等保障用户权益的相关内容。
用户应当阅读快递运单，正确填写收寄人的姓名、地址、电话及所寄物品的品名和数量，同时在相应位置签字确认。
快递运单适用《中华人民共和国合同法》关于格式条款的规定，公开的服务承诺视为合同条款。
第二十五条 快递企业组织投递应当不超出向用户承诺的服务时限，同城快递超过承诺时限三日，省内异地和省际快件超过承诺时限七日视为彻底延误快件，快递企业应当根据有关规定予以赔偿。
快递企业对快件提供至少两次投递。因收件人的原因投递两次未能投交的快件，收件人仍需要快递企业投递的，快递企业可以加收费用，并应当事先告知收件人收费标准。
第二十六条 快递企业应当根据国家规定加强对快递从业人员的职业技能培训。
快递企业从业人员中符合国家职业技能鉴定标准的人员比例应当达到国家规定的标准。
第二十七条 快递企业及其从业人员不得有下列行为：
(一)相互串通操纵市场价格，损害其他快递企业或者用户的合法权益；
(二)冒用他人名称、商标标识和企业标识，扰乱市场经营秩序；
(三)积压、扣押、延误寄递服务或者擅自中断寄递服务；
(四)本条例第二十条第(一)、(二)、(四)、(五)、(六)项规定的行为；
(五)寄递国家机关公文；
(六)法律、法规禁止的其他行为。
第六章 监督管理
第二十八条 邮政管理部门应当加强对邮政普遍服务、特殊服务、快递服务的监督管理，及时受理用户的申诉、举报，依法查处违反邮政法律、法规的行为。
邮政企业、快递企业应当设置用户意见簿、公布监督电话号码，接受用户对服务质量的监督，对用户的举报和投诉在十五个工作日内进行处理并予以答复。
第二十九条 邮政管理部门应当根据监管工作的需要，对外发布有关邮政业服务质量的报告。
第三十条 邮政企业、快递企业应当根据国家有关规定和邮政管理部门的要求报告企业有关经营情况、服务质量情况，提供准确、完备的统计数据和其他相关资料。
第三十一条 邮政企业撤销提供邮政普遍服务的邮政营业场所，应当向邮政管理部门提出书面申请，经邮政管理部门批准后方可撤销，并至少提前十日向社会公告。
邮政企业设置邮政营业场所和撤销不提供邮政普遍服务的邮政营业场所，应当事先书面告知邮政管理部门，并按要求提供有关材料。
第三十二条 邮政企业、快递企业应当加强安全生产管理，建立健全安全生产责任制度，完善安全生产条件，确保生产安全。
第三十三条 邮政企业、快递企业应当按照国家有关规定建立突发事件应急机制。发生重大通信事故或者重大服务阻断时，邮政企业、快递企业应当按照有关规定及时向省邮政管理部门报告。
第三十四条 邮政管理部门应当建立健全监督检查制度，加强邮政普遍服务和邮政市场的监督检查，按照国务院规定协助财政、审计部门对邮政企业使用邮政普遍服务补贴资金实施监督。
第三十五条 省邮政管理部门按照国家规定，指导邮政行业特有工种职业技能鉴定机构，开展快递企业的邮政行业特有工种职业技能鉴定工作。
第三十六条 开办集邮票品集中交易市场，申请人应当依法在邮政管理部门取得《集邮票品集中交易市场开办许可证》，凭《集邮票品集中交易市场开办许可证》向工商行政管理部门办理注册登记。
第三十七条 生产邮政用品(具)，应当符合国家标准或者邮政行业标准，由省邮政管理部门监制，核发监制证书。不得无证或者盗用、冒用、借用监制证号生产、销售邮政用品(具)。
第七章 法律责任
第三十八条 违反本条例第七条第二款规定，建设单位未按照国家规定的标准设置信报箱的，由邮政管理部门责令限期改正。逾期未改正的，由邮政管理部门指定其他单位设置信报箱，所需费用由该居民住宅楼的建设单位承担。
第三十九条 违反本条例第八条规定，擅自拆除、迁移邮政设施的，应当恢复原状或者赔偿损失。
第四十条 违反本条例第十八条规定，新建居民楼和新建单位具备通邮条件，并办理了投递登记手续，十五个工作日内不通邮的，由邮政管理部门责令邮政企业改正。
第四十一条 违反本条例第二十条第（一）、（八）项规定的，由邮政管理部门责令限期改正，并对邮政企业主管人员和其他直接责任人员由邮政管理部门或者所在单位给予处分；构成犯罪的，依法追究刑事责任。违反本条例第二十条第（二）、（四）、（五）、（六）、（七）项规定的，依照《中华人民共和国邮政法》的规定处罚。违反本条例第二十条第（三）项规定的，由价格主管部门依照《中华人民共和国价格法》的规定处罚。
第四十二条 违反本条例第二十七条第(一)、(二)、(三)项规定的，由邮政管理部门责令快递企业限期改正，并处二千元以上一万元以下罚款；情节严重的，处一万元以上三万元以下罚款；情节特别严重的，责令停业整顿直至吊销快递业务经营许可证。违反本条例第二十七条第（五）项规定的，由邮政管理部门或者工商行政管理部门责令改正，没收违法所得，并处五万元以上十万元以下的罚款；情节严重的，并处十万元以上二十万元以下的罚款；对快递企业，还可以责令停业整顿直至吊销其快递业务经营许可证。
快递企业从业人员有前款规定的违法行为，尚不构成犯罪的，由公安机关依法处理；构成犯罪的，依法追究刑事责任。
第四十三条 违反本条例规定的其它行为，法律、法规已有处罚规定的，从其规定。
第四十四条 邮政管理部门和其他有关部门工作人员滥用职权、玩忽职守、徇私舞弊的，由其所在单位或者有关主管部门对直接负责的主管人员和其他直接责任人员给予处分；构成犯罪的，依法追究刑事责任。
第八章 附则
第四十五条 本条例所称邮政普遍服务，是指邮政企业按照国家规定的业务范围、服务标准和资费标准，为中华人民共和国境内所有用户持续提供的邮政服务。
本条例所称特殊服务，是指邮政企业按照国家规定办理机要通信、国家规定报刊的发行，以及义务兵平常信函、盲人读物和革命烈士遗物的免费寄送等服务。
本条例所称快递业务，是指快速收寄、分发、运输、投递单独封装、具有名址的信件和包裹等物品，以及其他不需要储存的物品，按照承诺时限递送到收件人或者指定地点，并获得签收的寄递服务。
第四十六条 本条例自2012年10月1日起施行。2003年8月1日甘肃省第十届人民代表大会常务委员会第五次会议通过的《甘肃省邮政条例》同时废止。
