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河北省节能监察办法

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河北省节能监察办法

河北省人民政府


河北省节能监察办法


(2008年1月7日河北省人民政府第93次常务会议通过 2008年2月14日河北省人民政府令〔2008〕第7号公布 自2008年3月1日起施行)




第一条为规范节能监察工作,保障节能法律、法规的实施,提高能源资源利用效率,推动资源节约型、环境友好型社会的建设,制定本办法。

第二条本办法所称节能监察,是指节能行政主管部门和节能监察机构对能源生产、经营、使用单位和其他有关单位执行节能法律、法规、规章和节能强制性标准的情况进行监督检查,督促其加强节能管理和提高能源资源利用效率,并对违法行为依法予以制止和处理的活动。

第三条在本省行政区域内从事节能监察及其相关活动,应当遵守本办法。

法律、法规另有规定的,从其规定。

第四条县级以上人民政府及其有关部门应当建立科学、完整、统一的节能监测和考核体系,将节能降耗完成情况纳入经济社会发展综合评价体系,作为政府领导干部综合考核评价和企业负责人业绩考核的重要内容,实行严格的问责制,并加强对本地区节能减排目标责任的评价考核和监督核查工作。

县级以上人民政府有关部门和新闻媒体应当广泛宣传动员,充分发挥舆论监督作用,努力营造全社会关注、支持、参与节能工作的良好氛围。

第五条县级以上人民政府节能行政主管部门负责本行政区域的节能监察管理工作。省、设区的市人民政府节能行政主管部门设置的节能监察机构负责本行政区域的节能监察日常工作。

县级以上人民政府其他有关部门在各自职责范围内负责节能监察的有关工作,并接受同级节能行政主管部门的指导。

第六条节能行政主管部门和节能监察机构应当建立节能监察举报、投诉受理制度,向社会公布受理举报、投诉的电话和电子邮箱、网址。

对违反节能法律、法规、规章和节能强制性标准的行为,任何单位和个人都有权向节能监察机构举报或者投诉。

第七条省节能监察机构负责对年消耗能源在一万吨标准煤以上的企业以及国家和省确定的其他用能单位进行节能监察。设区的市节能监察机构在省节能监察机构的业务指导下,对年消耗能源不足一万吨标准煤的用能单位实施节能监察,并将监察结果报省节能监察机构备案。

第八条节能监察的主要内容是:

(一)在用能项目和其他相关项目设计、建设过程中执行节能设计规范、进行节能评估审查,以及在用能项目建成后依法用能、合理用能的情况;

(二)落后的耗能过高用能产品及生产设施、设备和工艺的淘汰及限制使用情况;

(三)执行单位产品能耗限额情况;

(四)生产的能源产品质量状况;

(五)用能产品生产经营单位执行能效限值标准和有关能效标识、标志制度的情况;

(六)采用节能技术措施的情况;

(七)用能单位建立健全节能管理制度,节能岗位和人员设置,节能教育培训,以及定期报送能源利用状况报告的情况;

(八)向本单位职工无偿提供能源或者发放能源使用补贴的情况。

第九条节能监察可以采取现场监察或者书面监察两种方式。

第十条有下列情形之一的,应当实施现场监察:

(一)用能单位因技术改造等原因,致使主要用能设备、生产工艺或者能源消费结构发生重大变化的;

(二)通过举报、投诉或者其他途径,发现用能单位涉嫌违反节能法律、法规、规章和节能强制性标准的规定使用能源的;

(三)需要对用能单位的能源利用状况进行现场监测的;

(四)需要现场确认用能单位落实节能整改措施情况的;

(五)按节能行政主管部门的要求应当进行现场监察的。

实施现场监察时,被监察单位的相关人员应当到场。未到场的,不影响监察工作正常进行。在现场监察过程中,节能监察人员应当制作监察笔录,如实记录监察的时间、地点、内容、参加人员和现场实际情况,并由节能监察人员和被监察单位的负责人签字确认。被监察单位负责人拒绝签字的,节能监察人员应当在监察笔录中注明。

第十一条实施书面监察的被监察单位应当按照节能监察机构规定的时间和内容等要求,报送能源利用状况报告和其他有关资料。能源利用状况报告的内容必须全面、准确,经法定代表人签字,并加盖被监察单位公章。

第十二条被监察单位应当配合节能监察机构实施节能监察工作,如实说明情况和提供有关资料及样品。不得拒绝、阻碍依法实施的节能监察工作,不得伪造、篡改、隐匿或者销毁有关资料和样品。

第十三条节能监察机构应当加强对节能监察人员的教育培训、业务考核和监督管理工作。节能监察人员应当熟悉节能法律、法规、规章和节能技术标准及有关专业技术知识,具备与本职工作相适应的业务能力,并依法取得行政执法证件。

第十四条节能监察机构及其监察人员实施节能监察时,可以采取下列措施:

(一)要求被监察单位提供与监察事项有关的资料和样品,并查阅、复印或者抄录有关资料;

(二)就监察事项涉及的问题向被监察单位提出质询,要求其如实作出解释和说明;

(三)对被监察单位与能源利用状况有关的生产设施、设备、工艺流程和生产经营场景、产品等进行记录、录音、录像、拍照;

(四)对被监察单位的用能设备和能源利用状况进行监测;

(五)制止、纠正被监察单位违反节能法律、法规、规章和节能强制性标准的行为。

第十五条节能监察人员与被监察单位有利害关系或者其他关系,可能影响公正监察的,应当回避。

被监察单位认为节能监察人员应当回避的,可以书面或者口头方式向节能监察机构提出。

第十六条节能监察机构实施节能监察时,应当维护被监察单位的生产、经营和工作秩序。不得泄露被监察单位的技术秘密和商业秘密,不得利用工作之便谋取不正当利益。

第十七条经节能监察确认被监察单位存在违反节能法律、法规、规章和节能强制性标准的用能行为的,节能监察机构应当向被监察单位下达《限期整改通知书》,责令其限期改正,并由节能行政主管部门依照《中华人民共和国节约能源法》和《河北省节约能源条例》等有关法律、法规、规章的规定予以处罚或者移送其他有关行政主管部门依法予以处罚;经节能监察确认被监察单位存在浪费能源行为但尚未违反节能法律、法规、规章和节能强制性标准的,节能监察机构应当向被监察单位下达《节能监察意见书》,提出节能建议或者改进措施。

《限期整改通知书》、《节能监察意见书》应当自监察工作结束之日起20个工作日内,送交被监察单位。

节能监察机构应当对《限期整改通知书》和《节能监察意见书》的落实情况进行跟踪检查。

第十八条被监察单位对节能监察机构下达的《限期整改通知书》或者《节能监察意见书》有异议的,可以自收到《限期整改通知书》或者《节能监察意见书》之日起20个工作日内,向节能行政主管部门申请复查。节能行政主管部门应当自收到复查申请之日起30个工作日内完成复查工作,并以书面形式将复查结论告知被监察单位。

第十九条节能监察机构实施节能监察不得向被监察单位收取费用。节能监察工作所需经费列入同级财政预算。

第二十条节能监察机构及其监察人员有下列情形之一的,对直接负责的主管人员和其他直接责任人员依法给予行政处分;构成犯罪的,依法追究刑事责任:

(一)不依法履行节能监察职责的;

(二)泄露被监察单位的技术秘密和商业秘密的;

(三)利用工作之便谋取不正当利益的;

(四)向被监察单位收取费用的;

(五)有其他违法行为的。

第二十一条被监察单位拒绝依法实施的节能监察,不如实提供有关资料和样品或者伪造、篡改、隐匿、销毁有关资料和样品的,由节能行政主管部门责令限期改正,逾期不改正的,处以三千元以上一万元以下的罚款。阻碍节能监察工作,应当予以治安管理处罚的,由公安机关依照《中华人民共和国治安管理处罚法》予以处罚;构成犯罪的,依法追究刑事责任。

第二十二条本办法自2008年3月1日起施行。


第五届全国人民代表大会第三次会议关于接受陈永贵解除国务院副总理职务的请求的决议

全国人民代表大会常务委员会


第五届全国人民代表大会第三次会议关于接受陈永贵解除国务院副总理职务的请求的决议

(1980年9月10日第五届全国人民代表大会第三次会议通过)

中华人民共和国第五届全国人民代表大会第三次会议决定:
接受陈永贵解除中华人民共和国国务院副总理职务的请求。

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.