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.
山东省高速公路交通安全条例
山东省人大常委会
山东省高速公路交通安全条例
（2006年9月29日山东省第十届人民代表大会常务委员会第23次会议通过）
第一章 总 则
第一条 为了保障高速公路交通有序、安全和畅通，根据《中华人民共和国道路交通安全法》、《中华人民共和国道路交通安全法实施条例》等法律、法规的规定，结合本省实际，制定本条例。
第二条 凡在本省管辖的高速公路上通行的机动车驾驶人、乘车人以及与高速公路交通安全活动有关的单位和个人，均应当遵守本条例。
第三条 高速公路交通安全管理工作坚持安全第一、标本兼治、预防为主的方针，遵循依法、便民、高效的原则。
第四条 省、设区的市人民政府应当加强对高速公路交通安全管理工作的领导，组织有关部门确定管理目标，建立健全高速公路交通安全工作协调机制，保障高速公路安全畅通。
第五条 省人民政府公安机关交通管理部门负责全省高速公路的交通安全工作，设区的市人民政府公安机关交通管理部门负责本辖区内高速公路的交通安全工作。省人民政府对高速公路交通安全管理体制另有规定的，按照其规定执行。
交通、安全生产监督、卫生、农业、环境保护、气象等部门和单位依据各自职责，做好有关的高速公路交通安全工作。
第六条 对高速公路交通安全管理工作，应当加强科学研究，推广、使用先进的管理方法、技术、设备。
第二章 通行规定
第七条 禁止下列人员、车辆进入高速公路：
（一）行人；
（二）非机动车；
（三）拖拉机、轮式专用机械车、全挂拖斗车、铰接式客车、悬挂试车号牌和教练车号牌的机动车；
（四）设计最高时速低于70公里的机动车。
高速公路养护等作业人员和用于养护的专用机动车，不适用前款规定。
第八条 进入高速公路的机动车，应当配备符合国家标准的故障车警告标志牌。
第九条 机动车行驶时，驾驶人和乘车人应当按照规定使用安全带。
第十条 进入高速公路的机动车严禁超载；载人不得超过核定载人数，载货不得超过核定载质量。
货运机动车除驾驶室外，其他任何部位不得载人。
客运机动车除车身外部的行李架和内置的行李箱外，不得载货。客运机动车行李架载货，从车顶起高度不得超过0.5米，从地面起高度不得超过4米。
机动车装载容易散落、飞扬、流漏物品时，必须对装载物严密封盖。
第十一条 高速公路管理和经营单位应当在高速公路重要路口的适当位置设立车辆载重检测装置。
机动车运载不可解体超限物品确需在高速公路上行驶的，应当依照法律、法规的规定执行；影响交通安全的，还应当按照公安机关高速公路交通管理机构指定的时间、车道和速度行驶，并悬挂明显标志。
机动车运载爆炸物品、易燃易爆化学物品以及剧毒、放射性等危险物品需要在高速公路上行驶的，应当按照公安机关高速公路交通管理机构指定的时间、车道和速度行驶，悬挂警示标志并采取必要的安全措施。
第十二条 机动车在高速公路上行驶时，最低时速不得低于60公里。小型载客汽车最高时速不得超过120公里，其他机动车不得超过100公里。机动车进入收费站通道时，最高时速不得超过5公里。机动车在服务区内最高时速不得超过20公里。法律、法规另有规定的，从其规定。
遇有限速交通标志或者限速路面标记所示时速与前款规定不一致时，应当按照标志或者标记标明的速度行驶。
第十三条 机动车从匝道驶入高速公路时，应当开启左转向灯，并在加速车道内将车速提高到60公里以上；驶入行车道时，不得妨碍其他机动车行驶。
机动车驶出高速公路时，应当按照出口预告标志提前开启右转向灯，驶入减速车道后驶离。
第十四条 同方向有2条车道的，左侧车道的最低时速为100公里。同方向有3条以上车道的，最左侧车道的最低时速为110公里，中间车道的最低时速为90公里；禁止大型客车、大型货车驶入最左侧车道。
遇有限速交通标志或者限速路面标记所示时速与前款规定不一致时，应当按照标志或者标记标明的速度行驶。
第十五条 机动车超越前方车辆时，应当提前开启左转向灯，从左侧相邻车道超车。同方向有2条车道的，大型客车、大型货车允许借用左侧车道超车，禁止超车后继续占用左侧车道和在左侧车道内连续超车；同方向有3条以上车道的，禁止大型客车、大型货车使用最左侧车道超车。
第十六条 机动车行驶中需要变更车道时，应当提前开启转向灯，夜间还须变换使用远、近光灯，确认与要进入车道的前方车辆以及后方车辆有足够的安全间距后，再驶入需要进入的车道。
第十七条 机动车行驶中发生故障需要临时停车时，应当提前开启右转向灯，在确保安全的情况下驶离原车道，停在应急车道或者路肩内，并立即开启危险报警闪光灯，在最右侧车道与应急车道或者路肩的分界线上、来车方向150米外设置故障车警告标志牌。
机动车排除故障后继续行驶时，应当在应急车道或者路肩上提高车速，并开启左转向灯；进入行车道时，不得妨碍其他车辆正常行驶。
第十八条 机动车行驶中因发生故障不能离开原车道的，驾驶人应当立即开启危险报警闪光灯，并在本车道内来车方向150米外设置故障车警告标志牌，夜间还需开启示宽灯和尾灯。驾驶人和乘车人应当迅速转移到右侧应急车道或者路肩外，并立即报警。
第十九条 设置故障车警告标志牌时，设置人应当在确保安全的情况下沿应急车道或者路肩外侧行走。
禁止以其他物品或者标志替代故障车警告标志牌。
第二十条 高速公路发生交通堵塞时，受阻机动车应当依次在行车道内等候，并开启危险报警闪光灯，不得驶入应急车道或者路肩。
第二十一条 机动车在高速公路上行驶时，驾驶人不得有下列行为：
（一）倒车、逆行、掉头或者穿越中央隔离带；
（二）进行试车和学习驾驶机动车；
（三）骑、压行车道分界线；
（四）在匝道、加速车道和减速车道内超车；
（五）非因紧急情形停车、上下人员或者装卸货物；
（六）拨打接听移动电话、收看编发移动电话信息；
（七）观看影视录像；
（八）妨碍安全驾驶的其他行为。
第二十二条 机动车驾驶人连续驾车行驶不得超过4小时，停车休息时间不得少于20分钟，24小时以内驾驶时间累计不得超过8小时。
第三章 交通安全保障
第二十三条 高速公路收费站对本条例第七条第一款规定禁行范围内的人员和车辆不得放行；对在进出站口闯岗、闯卡，不听劝阻强行通过的，应当立即报警，公安机关应当及时依法处理。
高速公路管理和经营单位及其收费站对公安机关查缉嫌疑车辆应当予以协助。
第二十四条 除公安机关的人民警察依法执行紧急公务外，任何单位、个人不得在高速公路上拦截检查行驶的车辆。
第二十五条 公安机关高速公路交通管理机构应当加强巡逻检查，对存有交通安全隐患或者有交通违法行为的车辆，应当通过喊话或者其他警示方式，责令其改正或者到高速公路出口、收费广场、服务区接受处理；遇有严重危及人身、车辆或者通行安全的紧急情形，可以责令其立即到指定的安全地点停车，予以纠正。
高速公路上发生交通事故、治安和刑事案件以及其他突发事件时，公安机关等有关部门应当及时赶赴现场，妥善处置。
在本辖区内执行正常巡逻任务、处理交通事故、处置突发事件的统一标志的制式警车，进出本辖区和与本辖区相邻的收费站免交车辆通行费。
第二十六条 遇有自然灾害、路面结冰、恶劣天气、道路抢修、交通事故、突发事件等情形，公安机关高速公路交通管理机构可以采取限制车速、调换车道、暂时中断通行等限制通行的管理措施，并及时通报高速公路管理和经营单位。
遇有前款所列情形，高速公路管理和经营单位可以先行采取安全防范措施，并立即报告公安机关高速公路交通管理机构。
公安机关高速公路交通管理机构、高速公路管理和经营单位应当积极采取措施，疏导并尽快恢复交通。有关单位和人员应当服从、配合。
第二十七条 遇有本条例第二十六条第一款所列情形，采取限制通行的管理措施难以保证交通安全时，公安机关高速公路交通管理机构可以采取关闭高速公路的交通管制措施，高速公路管理和经营单位应当予以执行。公安机关高速公路交通管理机构负责现场指挥疏导车辆。
关闭高速公路涉及2个以上管辖路段或者2条以上相邻的高速公路时，由共同的上一级公安机关高速公路交通管理机构负责协调。
高速公路收费站接到关闭高速公路的通知后，应当关闭收费站入口，并设置必要的交通分流引导设施。
引起关闭高速公路的情形消除后，实施关闭高速公路的单位应当及时开通高速公路。
第二十八条 公安机关高速公路交通管理机构、高速公路管理和经营单位应当收集、汇总高速公路的交通流量、交通事故、车辆行驶状态、施工作业等与通行有关的信息，完善信息数据库，相互提供信息，实现信息共享，不断提高智能化管理水平。
公安机关高速公路交通管理机构、高速公路管理和经营单位应当通过媒体、可变情报板等形式及时播发高速公路路况、气象、关闭、开通等信息。
公安机关高速公路交通管理机构、高速公路管理和经营单位应当联合建立全省统一的高速公路安全信息查询系统，向社会公布查询方式，方便公众查询。
第二十九条 公安机关高速公路交通管理机构发现高速公路交通事故频发路段以及配套设施存在交通安全严重隐患的，应当及时向高速公路管理和经营单位提出防范交通事故、消除隐患的建议；必要时，向同级人民政府报告。
第三十条 在高速公路两侧设置的广告牌、横跨高速公路的管线等，应当与交通设施保持必要的距离，不得遮挡交通标志或者标线、妨碍安全视距、影响通行。
高速公路交通标志、标线等交通设施应当保持良好状态；达不到规定标准的，应当及时修复、完善。禁止损毁和擅自移动、涂改高速公路交通标志、标线等交通设施。
新建高速公路的交通标志、标线等交通设施应当按照国家标准进行设计、安装。
第三十一条 在高速公路上进行养护、维修等作业时，应当按照高速公路养护工程作业交通控制的规定，实行作业区域交通安全控制，夜间还需放置红色示警灯或者反光锥筒。施工作业人员应当穿着安全标志服，佩戴安全标志帽，乘坐作业车辆出入作业区。作业车辆、机械应当悬挂明显标志，行驶和作业时均应当开启示警灯。
除日常维修养护作业外，进行养护施工应当事先通报公安机关高速公路交通管理机构。
第三十二条 高速公路养护施工单位进行养护作业需要半幅封闭或者中断交通的，应当事先通报公安机关高速公路交通管理机构，在施工5日前通过省级主要媒体发布公告，并在进入施工路段前的相关入口处和施工路段前方按照公安机关高速公路交通管理机构的要求设置公告标志牌。
第三十三条 除服务区外，禁止在高速公路内从事经营活动。
禁止进入高速公路隔离栅内从事放牧、耕作等活动。
第三十四条 在高速公路服务区内，车辆应当在指定的安全区域停车。
第四章 交通事故救援与处理
第三十五条 建立公安交警、消防、环保、医疗急救、高速公路管理和经营等单位参加的交通事故抢险救援联动机制，制定相应预案，做到快速反应，及时救援。
第三十六条 在高速公路上发生交通事故，驾驶人应当立即停车，开启危险报警闪光灯，夜间还需开启示宽灯和尾灯；驾驶人或者有关人员应当在本车道内来车方向150米外设置警告标志；驾驶人、乘车人应当立即转移到应急车道或者路肩外。
第三十七条 公安机关高速公路交通警察勘查交通事故现场完毕，应当快速撤除现场，恢复交通；因检验鉴定需要扣留事故车辆的，应当将事故车辆移至公安机关高速公路交通管理机构指定的地点，并妥善保管。
第三十八条 除清障救援车辆外，禁止其他机动车拖曳、牵引故障车辆或者事故车辆在高速公路上行驶。
清障救援车辆执行清障救援作业时，应当开启标志灯和危险报警闪光灯。
第三十九条 处理交通事故，由公安机关高速公路交通管理机构依照有关法律、法规和规章的规定执行。
第五章 法律责任
第四十条 公安机关交通管理部门及其交通警察对高速公路交通安全违法行为应当及时纠正，予以处罚；对于情节轻微、未影响道路通行的，应当指出违法行为，进行批评教育，给予口头警告后放行。
第四十一条 机动车驾驶人有下列行为之一的，处警告或者100元罚款：
（一）未按照规定系安全带上路行驶的；
（二）未按照规定超车或者变更车道的；
（三）驾驶车辆时拨打接听移动电话、收看编发移动电话信息的；
（四）驾驶车辆时观看影视录像的；
（五）载运货物散落、飞扬、流漏的。
第四十二条 机动车驾驶人有下列行为之一的，处警告或者200元罚款：
（一）驾驶禁止进入高速公路的机动车驶入高速公路的；
（二）违反规定拖曳、牵引故障车辆或者事故车辆的；
（三）驾驶车辆行驶时低于最低时速规定的；
（四）驶入高速公路时妨碍已在行车道内的机动车正常行驶的；
（五）车辆发生故障或者交通事故停车后，未按照规定使用灯光和放置警告标志的；
（六）货运机动车违反规定载人的；
（七）运载危险物品未悬挂警示标志而且未采取必要安全措施，或者未按照指定的时间、车道、速度行驶的；
（八）载物长度、宽度、高度超过规定的；
（九）运载不可解体超限物品，影响交通安全，未悬挂明显标志或者未按照指定的时间、车道、速度行驶的；
（十）遇有雾、雨、雪、沙尘、冰雹等低能见度气象条件时，未按照规定行驶的；
（十一）倒车、逆行、掉头或者穿越中央隔离带的；
（十二）在匝道、加速车道、减速车道内超车的；
（十三）骑、压行车道分界线或者在应急车道、路肩上行驶的；
（十四）非紧急情况，在应急车道或者路肩上停车的；
（十五）未按照规定停车、上下人员或者装卸货物的；
（十六）试车或者学习驾驶机动车的；
（十七）大型客车、大型货车驶入同方向有3条以上车道的最左侧车道的；
（十八）连续驾车行驶未按照规定时间休息的。
第四十三条 客运机动车违反规定载客载货的，按照下列规定处罚：
（一）载客超过额定乘员20%以下的，处200元罚款；
（二）载客超过额定乘员20%不足50%的，处1000元罚款；
（三）载客超过额定乘员50%以上的，处2000元罚款；
（四）违反规定载货的，处1000元罚款。
有前款行为的，由公安机关高速公路交通管理机构扣留机动车至违法状态消除。
第四十四条 货运机动车违反规定载物载客的，按照下列规定处罚：
（一）超过核定载质量不足30%的，处200元罚款；
（二）超过核定载质量30%以上不足50%的，处500元罚款；
（三）超过核定载质量50%以上不足100%的，处1000元罚款；
（四）超过核定载质量100%以上的，处2000元罚款；
（五）违反规定载客的，处2000元罚款。
有前款行为的，由公安机关高速公路交通管理机构扣留机动车至违法状态消除。
第四十五条 机动车行驶超过规定时速10%以上50%以下的，处200元罚款；超过规定时速50%的，处2000元罚款，可以并处吊销机动车驾驶证。
第四十六条 行人、非机动车进入高速公路的，处警告或者50元罚款，并责令其离开高速公路。
第四十七条 高速公路管理和经营单位拒不执行关闭高速公路的措施，致使进入高速公路的车辆发生重大事故以及造成其他严重后果的，依法承担相应责任。
第四十八条 对200元以下罚款，高速公路交通警察可以当场作出行政处罚决定。当事人向指定银行缴纳罚款确有困难的，经当事人提出，交通警察可以当场收缴。当场收缴罚款的，交通警察应当在《当场处罚决定书》存根上注明当场收缴的理由，并由被处罚人签名，同时开具由省财政部门统一制发的罚款收据。
第四十九条 公安机关高速公路交通管理机构的工作人员有下列行为之一的，依法给予行政处分；构成犯罪的，依法追究刑事责任：
（一）未按照规定将依法收缴的罚款全部上缴国库的；
（二）徇私舞弊，利用职务便利收受他人财物或者谋取其他利益的；
（三）当场收缴罚款不开具罚款收据，不如实填写罚款数额或者开具不符合规定罚款收据的；
（四）利用职权刁难、报复他人的；
（五）违法扣留车辆、车辆号牌、行驶证和驾驶证的；
（六）依法扣留车辆、车辆号牌、行驶证和驾驶证未按照规定上交的；
（七）未履行法定职责，导致出现交通事故、道路堵塞或者其他严重后果的；
（八）其他违反法律、法规的行为。
第五十条 对违反高速公路交通安全管理的行为，本条例未规定处罚的，依照《中华人民共和国道路交通安全法》、《中华人民共和国道路交通安全法实施条例》等法律、法规的规定执行。
第六章 附 则
第五十一条 本条例自2007年1月1日起施行。