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.
关于印发丹东市封山禁牧实施办法的通知
辽宁省丹东市人民政府
关于印发丹东市封山禁牧实施办法的通知
丹政发〔2010〕50 号
各县（市）区人民政府，市政府各部门：
《丹东市封山禁牧实施办法》业经2010年11月26日市政府第28次常务会议审议通过，现予印发。
丹东市人民政府
二○一○年十一月二十九日
丹东市封山禁牧实施办法
第一条 为保护和培育森林资源，改善生态环境，巩固全市造林绿化成果，根据《中华人民共和国森林法》、《辽宁省封山禁牧规定》等有关规定，结合我市实际，制定本实施办法。
第二条 本办法所称封山禁牧，是指禁止在林地内进行放牧的一种森林资源管护方式。
封山禁牧范围为本市行政区域内的所有林地，包括市、县(含县级市、区，下同)人民政府确定的宜林荒山荒地和退耕还林地。
第三条 凡在本市行政区域内从事森林生产经营、封山禁牧管理和放牧等相关活动的单位和个人，应遵守本办法。
第四条 封山禁牧遵循育林为本、以封为主、惩教结合、从严管理的原则。禁止任何单位和个人在林地内从事放牧等相关活动。
第五条 封山禁牧工作实行各级人民政府负责制，统一组织、部门配合、分区负责、同步推进。
县、乡(镇)人民政府负责组织实施本行政区域内封山禁牧和畜牧舍饲圈养工作。
市、县林业行政主管部门负责本行政区域内封山禁牧的具体工作。
畜牧、财政、发改委、农业、水利、交通、城建等部门按照各自职责，做好封山禁牧有关工作。
第六条 县、乡(镇)人民政府成立由畜牧、农业、财政等部门组成的封山禁牧工作领导小组，负责本行政区域内封山禁牧管理及行政执法工作，协调指导有关部门开展封山禁牧工作。县、乡(镇)封山禁牧工作领导小组办公室分别设在县森林公安部门和乡(镇)林业站，具体负责封山禁牧的日常监督管理、绩效考评、案件查处以及封山禁牧基础设施建设等管理工作，建立健全封山禁牧监督检查制度与考评奖罚办法，定期组织封山禁牧工作巡查、调度、评估，并将结果予以通报。
第七条 封山禁牧实行谁经营、谁管护，谁养殖、谁负责的管护责任机制。乡(镇)人民政府、村委会、村民组长要认真监督森林经营者履行森林资源的自我管护责任，并对畜牧养殖户及其畜牧养殖种类、数量进行登记造册、建立档案，与畜牧养殖户签订封山禁牧责任书，落实饲养户联保联防的自我约束措施。
第八条 要建立县、乡(镇)人民政府(国有林场)、村、合作组织(经营者)四位一体的封山禁牧协同督察监管体系。各级林业部门要经常深入林区、农户检查督促封山禁牧工作，加大对毁坏林木案件的惩处力度，依法查处放牧毁林等破坏森林资源行为。乡(镇)人民政府及林业站，国有、集体、私有林场，林业合作组织及林农应当建立护林协作组织，负责监督、制止禁牧区内的放牧行为。乡(镇)人民政府、村委会要认真监督履行集体林家庭承包经营合同，明确护林的义务和责任，建立封山禁牧源头监管机制。
第九条 生态公益林监管员、护林员要认真履行封山禁牧的巡查管理职责，加强对管护区域森林资源巡护和重点林地的死看死守，搞好对畜牧养殖户在林地放牧行为监管，协助森林公安、林业行政综合执法部门搞好畜牧毁林案件查处，有效制止和打击在封山禁牧范围内放牧及毁林行为。
第十条 封山禁牧的范围要落实到山头地块和造林小班，林地边界四至由县级人民政府确定并公布。县级林业行政主管部门应当在幼林地、生态脆弱区等重点保护林地周边设置必要的护栏等管护设施，采取围栏式封山禁牧。在重点畜牧饲养村组、主要路口和山口设立明显标识标志，明晰封禁要求并注明禁牧边界四至，扎实做好封山禁牧的基础工作。
第十一条 畜牧、农业、扶贫开发、林业等有关部门要科学制定畜牧业发展规划，加快畜牧饲草基地建设步伐，研究制定绒山羊、黄牛等畜牧舍饲圈养办法和扶持政策措施，鼓励、引导和扶持农民群众调整畜牧养殖品种结构，培育优质牧草，变传统畜牧散养为舍饲圈养。大力扶持畜牧养殖龙头企业，发展设施化、规模化、集约化畜牧舍饲养殖模式，搞好指导服务工作。农业、水利、交通等扶持政策要向畜牧业倾斜，支持发展设施化、规模化、集约化畜牧舍饲养殖。
第十二条 各有关部门要搞好封山禁牧的宣传教育工作，宣传封山禁牧的意义、法规政策和要求，引导农民群众自觉参入和维护封山禁牧工作。同时，宣传推广封山禁牧工作以及畜牧舍饲圈养的典型经验及做法，促进林牧业和谐有序发展。
第十三条 违反本办法，有下列行为之一的，由林业行政主管部门责令停止违法行为，依法赔偿损失，并按照下列规定处理：
(一)进入林地放牧的，给予警告，拒不改正的，按每只(头)牲畜处10元以上30元以下罚款;
(二)在林地内放牧致使森林、林木受到损坏的，限期补种毁坏株数1倍以上3倍以下树木;
(三)损毁或者擅自移动标志、护栏等管护设施的，限期恢复原状，处200元以上1000元以下罚款。
拒不补种树木或者补种不符合国家有关规定的，以及不恢复设施原状的，由林业行政主管部门代为补种或者恢复，所需费用由违法者支付。
第十四条 违反本办法情节严重，构成治安处罚的，由森林公安机关按照治安管理规定处罚;构成犯罪的，依法追究刑事责任。
第十五条 各级林业、畜牧等有关部门要按照职责分工，强化封山禁牧工作的执行力。对工作措施不力，由其上级主管机关责令改正，并予以通报批评，直至取消年度评优资格。
第十六条 对封山禁牧工作开展不到位、不作为，以至发生重大毁林案件，对林地放牧行为不依法查处或者有其他玩忽职守、滥用职权、徇私舞弊行为的，严肃追究有关部门和相关责任人的行政责任;构成犯罪的，依法追究刑事责任。
第十七条 建立健全各级政府和林业部门封山禁牧管理工作责任考评奖罚机制。将封山禁牧工作纳入“市县政府年度工作目标责任状” 和市县 “兴林杯”竞赛予以考评。
第十八条 县级人民政府可以根据本实施办法制定封山禁牧工作具体办法和措施。
第十九条 本实施办法由丹东市林业局负责解释。
第二十条 本实施办法自发布之日起施行。
