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吉林省长春市人民政府办公厅


长春市人民政府办公厅关于印发《长春国家科技兴贸创新基地管理办法》的通知

长府办发〔2009〕9号


各县（市）、区人民政府，市政府各委办局、各直属机构：

　　《长春国家科技兴贸创新基地管理办法》已经市政府同意，现印发给你们，请认真贯彻执行。



　　　　　　　　　　　　　　　　　　　　　　　　　　　　　长春市人民政府办公厅
　　　　　　　　　　　　　　　　　　　　　　　　　　　　　二○○九年三月二十日

　　长春国家科技兴贸创新基地管理办法

　　第一章总 则

　　第一条 为推动长春国家科技兴贸创新基地（以下简称“创新基地”）建设，促进长春市医药产业发展，根据商务部等八部委《关于建设科技兴贸创新基地的指导意见》（商产发〔2007〕509号）和《长春市人民政府办公厅印发关于促进长春国家科技兴贸创新基地（生物医药）建设若干意见的通知》（长府办发〔2008〕58号），制定本办法。

　　第二条 本办法所指创新基地是指由商务部和科技部授予我市的国家科技兴贸创新基地（生物医药）。

　　第三条 建设创新基地的主要任务是鼓励和扶持长春市医药产业技术创新，培育和壮大医药产业规模，推动医药产业集群发展，提升国际竞争力，优化贸易环境，加强公共服务平台建设，提高外贸增长质量和效益，促进贸易与科技、产业有机结合。

　　第四条 长春国家科技兴贸创新基地领导小组（以下简称“领导小组”）会同有关部门采取相应措施，营造有利于创新基地建设和发展的政策环境，对符合相关商务、科技、医药产业政策的创新基地企业及公共服务平台建设项目，将给予重点扶持。

　　第二章管理机构及职责

　　第五条 长春国家科技兴贸创新基地领导小组负责对创新基地建设工作进行管理和指导，贯彻落实国家关于创新基地建设的发展战略和有关政策，把握创新基地发展方向，研究制定配套政策措施；结合我市国民经济和社会、行业发展总体规划研究制定创新基地发展战略和建设规划；负责创新基地的领导和重大事项的决策；评定纳入创新基地管理的企业，并为企业做好服务。

　　第六条 长春国家科技兴贸创新基地领导小组办公室（以下简称“创新基地办公室”）设在长春市商务局，主要承担领导小组的日常工作并负责实施创新基地建设工作。其主要职责是：编制创新基地发展规划并报领导小组评定；组织实施创新基地发展规划；建立并完善创新基地管理体系；组织申报、评定创新基地企业，并负责对创新基地企业进行考核与评估；重点扶持符合开拓国际市场的创新基地企业及公共服务平台建设项目；指导、协调和管理创新基地建设中的重大项目；负责创新基地建设的统计、促进、调研和宣传工作;为创新基地企业开拓国际市场搭建平台,创造条件。

　　第七条 创新基地办公室要加强与创新基地成员单位的沟通和协调，积极争取相关国家政策和资金支持，完善创新基地政策环境，做好国家科技兴贸和自主创新政策的宣传落实，因地制宜地制定出台相关配套政策。

　　第八条 创新基地办公室要建立完善创新基地信息报送制度，加强调查研究，定期组织创新基地成员单位召开联席会议，通报基地建设情况、国家对创新基地建设发展的战略和政策、动态信息、工作经验、服务平台建设等。定期向领导小组和商务部、科技部报送创新基地建设情况，确保创新基地建设工作扎实有效地向前推进。

　　第九条 创新基地各成员单位要明确分工，加强合作，从各自职责出发，及时解决创新基地建设中存在的问题，促进创新基地建设工作的深入发展。

　　第十条 创新基地成员单位职责：

　　（一）市商务局：负责对我市医药产业进出口额及产品品种等数据的统计分析并及时通报创新基地办公室；负责与商务部、科技部的沟通与协调；负责创新基地各成员单位的沟通与协调；负责创新基地建设项目及创新基地企业项目的申报；组织召开创新基地联席会议；参与创新基地发展规划的制定和实施；指导符合条件的企业申报创新基地企业；参与创新基地企业的申报、评定及考核与评估；重点扶持符合开拓国际市场的创新基地企业及公共服务平台建设项目；参与指导、协调和管理创新基地建设中的重大项目及创新基地建设的统计、促进、调研和宣传工作。

　　（二）市科技局：负责对我市医药产业的研发投入、有效专利数量、发明专利数量、研发机构数量、创新基地企业国际研发合作情况等相关数据的统计分析并及时通报创新基地办公室；收集、整理我市医药产业科技创新项目并建立项目库；重点扶持创新基地企业的科技攻关项目及公共服务平台建设项目；推荐并指导创新基地企业申报国家及省的相关科技计划；参与创新基地发展规划的制定和实施；指导符合条件的企业申报创新基地企业；参与创新基地企业的申报、评定及考核与评估；参与指导、协调和管理创新基地建设中的重大项目及创新基地建设的统计、促进、调研和宣传工作。

　　（三）市药监局：负责对我市医药产业总产值、销售收入、利税总额、规模以上企业数量等相关数据的统计分析并及时通报创新基地办公室；收集、整理我市医药产业项目并建立项目库；参与创新基地发展规划的制定和实施；指导符合条件的企业申报创新基地企业；参与创新基地企业的申报、评定及考核与评估；重点扶持符合相关医药产业政策的创新基地企业及公共服务平台建设项目；参与指导、协调和管理创新基地建设中的重大项目及创新基地建设的统计、促进、调研和宣传工作。
　
　　（四）市财政局：会同创新基地办公室负责创新基地配套资金及创新基地项目扶持资金的申请、评审和拨付；会同创新基地办公室对创新基地配套资金及项目扶持资金进行管理与监督；参与创新基地发展规划的制定和实施；参与创新基地企业的申报、评定及考核与评估；参与指导、协调和管理创新基地建设中的重大项目及创新基地建设的统计、促进、调研和宣传工作。

　　（五）高新技术产业开发区管委会、经济技术开发区管委会：负责对所属行政辖区医药产业相关数据的统计分析并及时通报创新基地办公室；收集、整理所属行政辖区医药产业项目并建立项目库；指导所属行政辖区内符合条件的企业申报创新基地企业；参与创新基地发展规划的制定和实施；参与创新基地企业的申报、评定及考核与评估；参与指导、协调和管理创新基地建设中的重大项目及创新基地建设的统计、促进、调研和宣传工作。

　　（六）长春海关：负责对我市医药产业进出口额等数据的统计分析并及时通报创新基地办公室；参与创新基地发展规划的制定和实施；参与创新基地企业的申报、评定及考核与评估；参与指导、协调和管理创新基地建设中的重大项目及创新基地建设的统计、促进、调研和宣传工作；对创新基地企业实行便捷通关服务，加快通关速度；及时向创新基地办公室通报创新基地企业通关情况。

（七）吉林出入境检验检疫局：参与创新基地发展规划的制定和实施；参与创新基地企业的申报、评定及考核与评估；参与指导、协调和管理创新基地建设中的重大项目及创新基地建设的统计、促进、调研和宣传工作；对创新基地企业实行批准享受绿色通道和快速核放待遇；及时向创新基地办公室通报创新基地企业出入境检验检疫情况。

　　第三章创新基地企业的申报及认定

　　第十一条 创新基地办公室具体负责创新基地企业的申报、评定工作。

　　第十二条 创新基地各成员单位可根据本地区、本行业科技、贸易及医药产业发展情况，指导符合条件的企业进行申报。

　　第十三条 创新基地办公室在收到申报材料后，依据认定条件，本着公开、公正、透明原则，会同创新基地成员单位、行业专家，共同组成评审小组，对申请资料进行考察，形成评审意见，报领导小组审定。

　　第十四条 创新基地企业认定的基本条件

　　（一）在长春市行政辖区内注册，具有独立企业法人资格，从事医药、医疗器械出口或具备出口潜力的企业；

　　（二）企业生产规模和技术水平处于省内领先地位，原则上主营产品销售收入不低于500万元，研发投入达到或超过相关产品销售总额的3%；

　　（三）具有一定的研究开发能力和科技项目试验、应用能力。具备一定的公共服务能力；

　　（四）企业领导创新意识和经营管理能力强。企业产权清晰，管理规范，运行良好，融资能力强，银行信誉好。

　　第十五条 申报创新基地企业应报送创新基地申请书。申请书应包括以下内容：

　　（一）企业主营业务发展现状和进出口情况；

　　（二）企业主要产品的生产规模、技术水平及其在国内、国际市场的地位等相关情况的说明；

　　（三）企业技术创新活动及拥有自主知识产权、自主品牌情况；

　　（四）海关出具的进出口情况证明；

　　（五）其他相关材料。

　　第四章创新基地企业的考核与评估

　　第十六条 创新基地办公室会同创新基地成员单位每两年对创新基地企业进行考核与综合评估。

　　第十七条 对创新基地企业考核与评估的主要内容是：

　　（一）创新基地企业发展总体情况。主要是创新基地企业销售总额和利税情况等；

　　（二）创新基地企业国际竞争力提高情况。主要是创新基地企业出口额和增幅，开拓国际市场情况等；

　　（三）创新基地企业自主创新能力建设情况及技术水平提升情况。主要是创新基地企业研发投入情况，自主知识产权发展情况，包括专利、专有技术、自主品牌建设、标准和公共服务平台建设等。

　　第十八条 对发展良好的创新基地企业要总结宣传典型经验，并加大支持力度；对长期发展缓慢的创新基地企业应进行重新评估，达不到要求的，将取消创新基地企业资格。

　　第十九条 有关创新基地企业发展的各项统计数据，要准确科学，不得瞒报、虚报。一旦发现有瞒报或虚报情况，经核实将予以警告、通告批评，直至取消其创新基地企业资格并追究相关人员责任。
第五章 附 则

　　第二十条 本办法由创新基地办公室负责解释。

　　第二十一条 本办法自印发之日起施行。


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.