国土资源部


国土资源部文件

国土资发〔2007〕210号


关于印发《全国土地执法百日行动方案》的通知

各省、自治区、直辖市国土资源厅（国土环境资源厅、国土资源局、国土资源和房屋管理局、房屋土地资源管理局），计划单列市国土资源行政主管部门，新疆生产建设兵团国土资源局，各派驻地方的国家土地督察局，中国地质调查局及部其他直属单位，部机关各司局：
　　为保证国家土地法律法规和土地调控政策的有效实施，巩固土地市场治理整顿成果，坚决惩处土地违法违规行为，部决定集中开展以查处“以租代征”为重点的全国土地执法百日行动，现将《全国土地执法百日行动方案》印发给你们，请认真贯彻执行。
　　　　　　　　　　　　　　　　　　　　　　　　　　　　　国土资源部
　　　　　　　　　　　　　　　　　　　　　　　　　　 二○○七年九月十二日



全国土地执法百日行动方案

　　为解决当前土地执法方面存在的突出问题，部决定从现在起到今年底，集中100天时间，开展以查处“以租代征”为重点的全国土地执法百日行动。
　　一、总体要求
　　通过集中清理2005年1月1日以来“以租代征”、违反土地利用总体规划扩大工业用地规模、未批先用等土地违法违规行为，坚决查处违法违规案件，有效遏制土地违法违规现象有所上升的态势，进一步落实最严格的土地管理制度，坚守18亿亩耕地“红线”，保证国家土地法律法规的贯彻执行，确保中央土地调控政策的有效实施。
　　二、主要任务和工作目标
　　（一）“以租代征”行为的整治。重点查处违反土地利用总体规划和土地利用年度计划，规避农用地转用和土地征收审批，通过出租（承租）、承包等方式非法使用农民集体所有土地进行工商企业项目建设的“以租代征”行为。到今年底，国土资源管理部门要对“以租代征”的违法违规问题，逐一清查到位，并依照有关法律法规的规定严肃处理。对未依法办理农用地转用和土地征收审批，国家机关工作人员批准“以租代征”占地建设的，要追究其非法批地的法律责任；对单位和个人擅自通过“以租代征”占地建设的，要追究其非法占地的法律责任。
　　（二）违反土地利用总体规划扩大工业用地规模行为的整治。重点查处现有已审核公告的开发区擅自突破国土资源部核定的四至范围，违反土地利用总体规划圈占土地的行为；查处以“工业集中区”等名义，违反土地利用总体规划圈占土地进行工业用地开发的行为。到今年底，全面清理开发区或以“工业集中区”等名义违反土地利用总体规划圈占土地的问题，对发现的问题分类进行处理，进一步规范开发区用地行为，巩固开发区清理整顿成果。在新一轮土地利用总体规划批准之前，各地一律不得在规划范围外以开发区、“工业集中区”、“产业集聚区”等各种名义非法调整规划。
　　（三）“未批先用”行为的清理和整治。重点清查城市批次建设用地未依法办理建设用地审批手续，先行征地、供地、施工建设的违法违规行为。到今年底，全面查清各地城市批次建设用地“未批先用”的建设项目，在查清事实的基础上，予以处理。对单独选址建设项目未依法办理建设用地审批手续，擅自先行动工建设的行为，到今年底，要查清事实，分析原因，明确责任，区分不同情况，分类提出处理意见。同时，要研究进一步改革和完善建设用地报批程序的办法。
　　三、工作安排百日行动分三阶段进行：
　　（一）自查清理阶段（9月15日至10月14日）。部专门召开视频会议部署百日行动。各级国土资源管理部门要根据百日行动方案以及视频会议精神要求，组织部署本行政区域内土地违法违规问题的清理工作。自查清理要充分利用卫片执法检查等工作成果，全面查清问题后统一登记填表（表格见附件），并将清理结果汇总报部，同时抄送派驻地方的国家土地督察局。
　　（二）查处纠正阶段（10月15日至11月24日）。上级国土资源管理部门要对发现的违法违规问题，依照有关法律法规的规定，查处到位；对清理出的管理不规范问题，要采取措施，予以纠正。部从各省级国土资源管理部门抽调人员组成工作组，对自查清理、查处纠正工作以及第七次卫片执法检查的进展情况进行检查。
　　（三）督察整改阶段（11月25日至12月25日）。各级国土资源管理部门要针对清查各类土地违法违规案件中暴露出的管理问题，举一反三，制定以完善制度和程序，明确执法责任为重点的整改方案。部党组成员带队组成检查组，对部分地区的查处纠正情况进行检查，并开展对重大问题的调研。各派驻地方的国家土地督察局对压案不查、查处不力的，要督促整改。
　　四、工作要求和措施
　　（一）加强领导，统一认识。部成立领导小组统一领导百日行动。领导小组由部党组书记、部长、国家土地总督察徐绍史任组长，部党组副书记、副部长、国家土地副总督察李元，部党组成员、国家土地副总督察甘藏春任副组长，部各有关司局主要负责人为领导小组成员。领导小组下设办公室，甘藏春兼任办公室主任，具体工作由部执法监察局和国家土地总督察办公室负责。各级国土资源管理部门要从实践“三个代表”重要思想和贯彻落实科学发展观的高度，充分认识本次行动的重要性和紧迫性。要按照行动方案的要求，逐级认真动员部署，建立相关工作机制，确定具体的工作任务和目标，成立专门的工作班子，全面领导实施本行政区域内的百日行动。
　　（二）统筹兼顾，协同配合。今年以来，监察部、国土资源部部署了进一步开展查处土地违法违规案件专项行动，监察部等五部门联合开展了国有土地使用权出让情况专项清理，农业部等七部委联合部署了开展全国农村土地突出问题专项治理。地方各级国土资源管理部门要按照专项行动、专项清理、专项治理和本次百日行动的部署和要求，统筹兼顾，积极开展相关工作，确保完成各项任务。百日行动中的重大问题，要及时向当地党委、政府汇报，特别是涉及本部门难以解决的问题，要主动提出建议，积极争取当地党委、政府的支持，要做好与有关部门的沟通协调工作，共同研究解决土地管理和土地执法中的关键问题。各派驻地方的国家土地督察局负责对专项行动、专项清理、专项治理和百日行动的全过程督察，按照各项工作的要求，明确各阶段的督察重点，推动各项工作的有效开展和落实。
　　（三）依法查处，督促整改。地方各级国土资源管理部门要严格依法依纪处理土地违法违规问题，严肃处理以罚代法、处罚不到位的行为。对土地违法违规涉及到应当追究国家机关工作人员行政责任的，要移送监察部门；涉及犯罪的，要移送司法机关。严格追究瞒案不报、压案不查的责任。对于不认真组织查处的，部将直接立案查处，并追究有关人员的责任。对土地违法违规问题严重的地区，实行问责。各派驻地方的国家土地督察局对压案不查或查处不力的地区，应及时向有关省级及计划单列市人民政府发出整改意见书；整改不力的，报请国家土地总督察责令限期整改，限期整改期间暂停该地区农用地转用和土地征收审批。
　　（四）积极宣传，营造氛围。最近一个时期，各级国土资源管理部门的宣传工作要以百日行动为重点，要充分利用广播、电视、报刊、网络等媒体，大力宣传百日行动各阶段的整治成果和查处违法违规用地行为的进展情况，保持舆论的高压态势。要定期召开新闻发布会，发布相关信息，通报百日行动的进展情况。各地都要通过媒体曝光一批影响恶劣的案件。要通过声势浩大、卓有成效的宣传活动，大力宣传中央关于严格土地管理，坚决打击土地违法违规行为的坚定决心，牢固树立依法管地、依法用地的观念，营造良好的土地管理氛围。
　　（五）建章立制，规范管理。各级国土资源管理部门要通过百日行动，认真总结土地管理的经验，针对土地管理和土地执法中存在的问题，立足于从管理上查找原因，对尚未建立管理制度的，要限期建立；对制度不落实、管理不到位的，要研究落实措施；要建立公开透明的办事程序和集体决策制度，进一步规范工作程序，促进依法行政和依规办事。部将对百日行动组织开展情况、土地违法违规案件查处情况等予以通报。各省级国土资源管理部门要在每个阶段结束后（10月14日、11月24日、12月25日）将百日行动各阶段进展情况汇总报告领导小组办公室，重大情况随时报告。
　　附件：1、土地违法违规情况汇总表
　　 2、通过“以租代征”方式使用农民集体所有土地进行工商企业项目建设用地调查统计表
　　 3、违反土地利用总体规划扩大工业用地规模情况统计表
　　 4、城市批次建设用地“未批先用”情况统计表
　　 5、单独选址应报国务院审批建设项目用地“未批先用”情况统计表
　　 6、单独选址应报省级政府审批建设项目用地“未批先用”情况统计表
　　　　　　　　　　　　　　　　　　　　　　　 　　二〇〇七年九月十二日


　　附表.xls

　　土地执法百日行动有关表格填报的补充说明.doc




土地执法百日行动有关表格填报的补充说明

一、省级人民政府批准或者由省级人民政府授权的设区市（自治州）人民政府批准的村庄、集镇批次建设用地，在附表4-1中填报。
二、附表4-1、附表4-2、附表4-3中，“用地时间”填报供地时间，即法定用地时间；“实际用地时间”填报“未批先用”建设单位实际用地时间；“审批时间”填报法定批准机关出具建设用地审批意见的时间。



百日行动领导小组办公室
二〇〇七年九月十八日





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.