广西壮族自治区南宁市人民政府


南宁市人民政府关于印发《南宁市城市建筑垃圾管理暂行办法》的通知


南府发〔2005〕64号　
各县、区人民政府，各开发区管委会，市直各委、办、局（公司）：
《南宁市城市建筑垃圾管理暂行办法》已经市人民政府常务会议审议通过，现印发给你们，请认真贯彻执行。
二○○五年六月十日

南宁市城市建筑垃圾管理暂行办法





第一条 为加强城市建筑垃圾的管理，保障我市市容环境卫生，根据《南宁市城市市容环境卫生管理条例》和建设部《城市建筑垃圾管理规定》及有关法律法规的规定，结合本市实际，制定本实施办法。
第二条 本实施办法适用于本市城市规划区内建筑垃圾的倾倒、运输、中转、回填、消纳、利用等处置活动。
第三条 本办法所称建筑垃圾是指建设、施工单位新建、改建、扩建和拆除各类建筑物、构筑物、管网等以及居民装饰装修房屋过程中所产生的弃土、弃料及其它废弃物。
建筑垃圾消纳场是指建筑垃圾专用处置场地和需要受纳建筑垃圾回填基坑、洼地的建设工地、规划开发用地。第四条 市市容环境卫生行政主管部门负责全市建筑垃圾管理工作，其主要职责是：
（一）制定建筑垃圾的处置规划并纳入市容环境卫生专业规划；
（二）负责建筑垃圾的处置审核；
（三）研究建筑垃圾无害化处理及综合利用；
（四）指导、协调、监督、检查市环境卫生管理处对建筑垃圾处置的日常工作。
市环境卫生管理处具体负责建筑垃圾的日常管理工作，其主要职责是：
（一）制定建筑垃圾处置计划，合理安排各类建设工程需要回填的建筑垃圾；
（二）统一管理建筑垃圾消纳场；
（三）监督建筑垃圾的倾倒、运输、中转、消纳、利用等处置活动；
（四）按价格行政主管部门核定的标准收取建筑垃圾处理费；
（五）受市市容环境卫生行政主管部门的委托对违反本办法的行为进行处罚。
第五条 建筑垃圾的处置实行减量化、资源化、无害化和谁产生、谁承担处置责任的原则。
支持和鼓励建筑垃圾综合利用，鼓励建设单位、施工单位优先采用建筑垃圾综合利用产品。
第六条 建筑垃圾消纳场及处理设施应当根据城市建设和管理的需要，统一规划、合理布局，多渠道筹集资金建设。
第七条 公安、交通、规划、国土、建设、环保、财政、物价等部门按照各自职责，协同市容环境卫生行政主管部门做好建筑垃圾管理工作。
第八条 任何单位和个人都有权制止和举报乱堆、乱倒建筑垃圾的行为。
第九条 需要处置建筑垃圾的单位，应当向市市容环境卫生行政主管部门提出申请，经核准后，方可处置。
第十条　建设单位、施工单位或者运输单位申请城市建筑垃圾处置核准的，应当在建设工程开工前携带建设工程的有关资料向市市容环境卫生行政主管部门提出书面申请，申请应说明建筑垃圾运输的时间和处置地点名称。核准时需与市市容环境卫生行政主管部门签订市容环境卫生责任书。
第十一条 运输建筑垃圾的单位应有健全的运输车辆运营、运输安全、运输质量、车辆保养、行政管理等制度并得到有效执行；运输车辆具备全密闭运输机械装置或密闭苫盖装置、安装行驶及装卸记录仪和相应的建筑垃圾分类运输设备；运输车辆有合法的道路运输经营许可证、车辆行驶证；
运输建筑垃圾的单位应与施工单位签订委托运输协议书。
第十二条 城市建筑垃圾消纳场所应当公示消纳场的场地平面图、进场路线图，制定建筑垃圾分类处置的方案和对废混凝土、金属、木材等回收利用的方案，制定健全的环境卫生和安全管理制度并得到有效执行。
城市建筑消纳场所应当配备相应的摊铺、碾压、除尘、照明等机械和设备，以及排水、消防等设施，出入口道路应当硬化并设置规范的净车出场设施。
第十三条 建筑垃圾运输单位应当严格依核准事项实施运输活动，变更原核准范围运输建筑垃圾的，应当重新办理建筑垃圾运输核准手续。
建筑垃圾运输单位应当按照市市容环境卫生行政主管部门核定的时间、路线、地点运输和倾倒。
第十四条　运输建筑垃圾的车辆应当进入指定的消纳场地，并服从场地管理人员的指挥，按要求卸放。
第十五条 运输建筑垃圾的车辆驶出施工场地和消纳场前，应当冲洗车体，净车出场。
第十六条 建设单位需要进行场地回填、在建工地需要利用建筑垃圾的，应向市环境卫生管理处提出申请，如实申报建筑垃圾的种类、数量，由市环境卫生管理处进行统一调剂，合理安排。
第十七条 居民自行进行房屋零散装饰装修的，应当将装饰装修房屋过程中产生的建筑垃圾进行装袋收集，不得与生活垃圾混装。
居民将建筑垃圾堆放在装饰装修房屋所在城区（开发区）市容环境卫生管理部门指定的地点，统一由相应市容环境卫生管理部门组织有偿清运。
第十八条 建筑垃圾消纳场地的选址应当符合城市总体规划和土地利用总体规划，其中专用处置场地由市市容环境卫生、国土、环保、规划部门共同确定，并有计划地建设。
第十九条 建筑垃圾消纳场的管理应当规范，符合环境卫生和环境保护的要求，并做到：
（一）按市市容环境卫生行政主管部门规定的时间受纳建筑垃圾。
（二）入场的建筑垃圾应及时推平、辗压；
（三）保持消纳场的进场道路整洁、畅通；
（四）有健全的现场运行管理制度和完整的原始记录，如实填报建筑垃圾处置相关报表；
（五）建筑垃圾按可利用和不可利用分类堆放；
（六）保持场内的环境整洁，场内没有蚊蝇滋生地，防止尘土飞扬，污水流溢；
（七）不得受纳工业垃圾、生活垃圾和有毒有害垃圾；
（八）建筑垃圾消纳场无法继续消纳垃圾时，应提前10个工作日向市市容环境卫生行政主管部门报告；
（九）不得擅自关闭消纳场或拒绝消纳建筑垃圾。
第二十条 建筑垃圾消纳场停止使用时，设立建筑垃圾消纳场的单位应当对消纳场地实施覆盖，搞好绿化，或按城市规划要求进行处理，并向市市容环境卫生行政主管部门备案。
第二十一条 各类工程产生的建筑垃圾应当及时处置，有条件的，在处置前可暂时堆放在同一工程用地范围内，工程完工后由建设、施工单位按本实施办法的规定清理完毕。
第二十二条 有下列情形之一的，不得设置建筑垃圾消纳场：
（1）学校、医院、居住区、商业中心等人口集中区域半径2公里范围内；
（2）农村承包的土地；
（3）生活饮用水、地下水水源保护范围内；
（4）自然保护区、风景名胜区；
（5）其他需要特别保护的区域内。
第二十三条 市环境卫生管理处收取的建筑垃圾处置费应按规定存入指定专户，接受财政、物价等部门的监督检查。
第二十四条　对违反本办法的行为，市市容环境卫生行政主管部门有权依照相关法律进行行政处罚。
第二十五条 本办法自2005年6月10日起实施。

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.