对外贸易经济合作部、国务院台湾事务办公室、外交部、公安部、交通部、农业部关于整顿对台远洋渔工劳务经营秩序的紧急通知
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对外贸易经济合作部、国务院台湾事务办公室、外交部、公安部、交通部、农业部关于整顿对台远洋渔工劳务经营秩序的紧急通知
对外贸易经济合作部、国务院台湾事务办公室、外交部、公安部、交通部、农业部关于整顿对台远洋渔工劳务经营秩序的紧急通知
对外贸易经济合作部 国务院台湾事务办公室 外交部 公安部 交通部 农业部
各省、自治区、直辖市、计划单列市外经贸委（厅、局），台办、外办、公安厅（局）、交通厅（局），中央管理的外经贸企业及其他五家外经贸企业：
近来，我对台湾远洋渔工劳务人员合法权益受侵害的恶性事件屡有发生，为整顿经营秩序，确保我劳务人员合法权益，现将有关事项通知如下：
一、清理整顿对台湾远洋渔工劳务业务，重新确定经营公司。
（一）自对台远洋渔工劳务工作紧急会议结束之日（5月18日）起，各经营公司一律停止签订新的对台远洋渔工劳务合同。对5月18日以后签订的合同，各级外经贸主管部门一律停止报送、审批，各级外事、公安、交通部门停止办照办证。5月18日之前所签合同，各经营公司可
凭外经贸部有效批文办理外派手续。尚未终止的合同不得延期。对所派出的渔工劳务人员必须按规定严格进行培训，保证素质。各级外经贸、外事、公安、交通等部门应严格把关。
（二）自本通知下发之日起，凡经外经贸部批准从事对台远洋渔工劳务经营的公司，均应对其业务情况进行清查，对在执行中的合同逐一填表（见附件）登记，连同开展此项业务的书面总结送各地外经贸主管部门汇总后于7月10日之前报外经贸部（国外经济合作司），中央管理的外
经贸企业直接报外经贸部。
（三）外经贸部将会同有关部门在总结经验的基础上，完善对台远洋渔工劳务管理办法，重新确定经营公司，并实行动态管理。在此之前，任何地区、任何公司不得从事新的对台远洋渔工劳务经营活动。
二、严格把关，加强管理，防止恶性事件发生。
（一）对执行中合同项下渔工劳务人员的派出，各经营公司必须严格按标准合同执行。在培训中应向渔工劳务人员详细解释合同条款和在外如何保护自身合法权益。渔工出境前必须依法申请办理海员证。
（二）对台湾船长或其他船员虐待、殴打我渔工劳务人员，危及其尊严及生命安全的事件，经营公司须立即与台湾签约公司进行严正交涉。如交涉未果，应将劳务人员召回，并将情况及时报有关部门。
（三）经营公司要及时向外经贸部、外交部报告有关案情，同时要密切配合外经贸部、外交部及有关使馆对案件的处理工作。
（四）有关经营公司对已发生的恶性事件须尽快妥善处理，力争我受害劳务人员或其家属得到公正合理的赔偿。
三、停止与严重侵害我经营公司及外派渔工劳务人员合法权益的台湾渔业公司的合作。
（一）对蓄意挑起我经营公司内部恶性竞争，克扣我劳务人员工资，打骂欺压我劳务人员，对我劳务人员的正当要求（治病、治伤、按期回国）不能予以满足的台湾渔业公司（名单另行通知），禁止经营公司与其签订新的对台远洋渔工劳务合同。
（二）除协调解决纠纷和对我受害渔工的赔偿外，各经营公司不得邀请被禁止签约的台湾公司的法人代表及其他经营管理人员来大陆洽谈业务。
四、服从大局，严肃纪律，加大处罚力度。
为使对台远洋渔工劳务的整顿工作达到预期效果，各有关部门应齐抓共管，并严肃纪律，加大对违规行为的处罚。
（一）各政府部门必须严格执行国家相关的法律及政策规定，对违反本通知的行为，要追究负责人及主要责任人的责任，并视情节轻重，由有关部门给予处罚。
（二）对不遵守本通知规定的经营公司，在重新确定经营公司时不予考虑；情节严重者，根据现行有关法规，取消对外劳务合作经营权，并追究企业法人代表及主要责任人的责任。
请各有关单位及经营公司进一步提高认识，认真领会中央及国务院领导批示精神，切实贯彻对台远洋渔工劳务工作紧急会议精神，认真执行本通知的决定，确保我对台远洋渔工劳务健康有序的发展。
请分别将此通知转发至各下属机构、经营公司。
1999年6月22日
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Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration
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《营口市小企业贷款抵押收费暂行办法》的通知
关于印发《营口市小企业贷款抵押收费暂行办法》的通知
营政办发〔2006〕79号
营口开发区、辽宁（营口）沿海产业基地、营口高新区管委会，各市（县）、区人民政府，市政府各部门、各直属单位：
《营口市小企业贷款抵押收费暂行办法》业经市十三届人民政府第51次常务会议讨论通过，现予印发。
二〇〇六年十月二十六日
营口市小企业贷款抵押收费暂行办法
第一章 总则
第一条 为推进我市小企业贷款工作，进一步规范小企业抵押贷款的收费行为，切实减轻小企业负担，根据《辽宁省人民政府办公厅关于进一步规范抵押贷款收费的通知》（辽政办发〔2001〕93号）规定，结合我市实际，制定本办法。
第二条 政府有关部门和中介机构办理小企业抵押贷款适用本办法。
第三条 本办法所称小企业是指依法设立的、由市中小企业局认定并核发小企业证书的工商和个体私营企业。小企业在金融机构办理抵押贷款时，凭小企业证书享受本办法规定的优惠政策。
第四条 政府有关部门和中介机构办理小企业抵押贷款时，除为保证贷款资金安全所必须履行的法定登记外，不得随意要求进行其他任何登记和收费。抵押物的抵押权益登记有效期限应与贷款期限相一致。
第五条 小企业办理抵押贷款，抵押物需要评估的，按照“谁委托、谁付费”的原则，由委托方自行委托有资格的评估机构进行评估，任何部门和单位不得强迫企业到指定的评估机构接受服务及交费。
第六条 评估机构收费必须坚持公正、公开的原则，向用户公开收费项目和收费标准，并认真执行收费规定。
第二章 抵押登记收费范围和收费标准
第七条 小企业以土地使用权作为抵押物的，土地管理部门可收取土地抵押登记费。使用面积在1000平方米以下，每宗地收费标准50元，每超过500平方米以内加收20元，最高不超过5000元。
第八条 小企业以房屋产权作为抵押物的，房产管理部门可收取房产抵押登记费。收费标准为抵押额的1‰，最高不超过2000元。
第九条 小企业以机动车作为抵押物的，公安部门可收取机动车抵押登记费。收费标准为每辆100元。
第十条 申请贷款的小企业土地使用权、房屋产权和机动车登记期满，继续利用同一抵押物申请抵押贷款续期的，每次只收取工本费10元，不再收取抵押登记费。
第十一条 以土地使用权、房屋产权及机动车以外的物品作为抵押物的，任何部门和单位不得收取抵押登记费。
第三章 评估服务和评估收费
第十二条 小企业办理抵押贷款，抵押物评估收费标准为：
（一）土地评估收费按土地评估总额的1‰至0.45‰分档收取（具体收费标准见附件表一）。
（二）房产评估收费按房产评估总额的1.25‰至0.625‰分档收取（具体收费标准见附件表二）。
（三）机器设备评估收费，评估总额在50万元以下部分，收费标准为50元；50万元以上部分按1‰至0.25‰分档收取（具体收费标准见附件表三）。
第十三条 在贷款期限内，评估机构不得对抵押物重复进行评估收费。小企业以同一抵押物申请抵押贷款续期，委托前次评估机构再次进行评估的，其收费标准在本办法第十二条规定的收费标准的30％的幅度内计收。
第十四条 对抵押物进行评估，须以与贷款规模相适应的有效抵押物的评估金额为基数计取费用，不得采取扩大评估标的范围或虚高估价的方式多收费。
第十五条 抵押物所有权清楚，贷款企业和贷款银行对其价值双方认估，不再评估。贷款企业能提供证明抵押物当期价值有效文书的，贷款银行不得要求对抵押物进行评估。
第四章 公证、鉴证和保险收费标准
第十六条 对小企业抵押贷款及贷款合同不得强制进行公证、鉴证，如需进行公正、鉴证，公证费和鉴证费由提出方支付。
第十七条 公证机构收取的公证费标准为：抵押登记公证每件收取100元，贷款合同公证按标的额的2.5‰至0.75‰分档收取（具体收费标准见附件表四）。
第十八条 工商行政管理部门收取的合同鉴证费，按合同金额0.25‰收取，最高不超过700元。
第十九条 对抵押物的保险应本着自愿原则，由贷款银行与贷款企业进行协商。
第五章 监督管理
第二十条 对小企业抵押贷款服务的收费情况，政府有关部门和中介机构应定期向市小企业贷款工作领导小组报告。领导小组办公室要对小企业抵押贷款收费情况进行经常性检查，对违反本办法规定的收费行为要严肃查处。
第二十一条 小企业在办理抵押贷款过程中，对政府有关部门和中介机构不按本办法规定收费的，可拒绝交费，并可向各级价格主管部门举报投诉。
第二十二条 政府有关部门和中介机构要向用户公示抵押贷款收费项目、收费标准和收费办法，规范收费行为，自觉接受用户监督和价格主管部门的检查。
第六章 附则
第二十三条 本办法由市中小企业局（市经委）负责解释。
第二十四条 本办法自发布之日起施行。
附件：相关收费标准
附件
相关收费标准
表一：宗地地价评估收费标准
档次
土地价格总额（万元）
收费标准（‰）
1
100以下（含100）部分
1
2
101——200部分
0.75
3
201——1000部分
0.45
表二：以房产为主的房地产价格评估收费标准
档次
房地产价格总额（万元）
收费标准（‰）
1
100以下（含100）部分
1.25
2
101——1000部分
0.625
表三：机器设备评估收费标准
档次
评估值（万元）
收费标准（‰）
1
51——100部分
1
2
101——500部分
0.5
3
501——1000部分
0.25
表四：抵押贷款合同公证收费标准
档次
合同金额（元）
收费标准（‰）
1
2万以下（含2万）部分
2.5
2
2万——5万（含5万）部分
2
3
5万——10万（含10万）部分
1.5
4
10万——50万（含50万）部分
1.25
5
50万——100万（含100万）部分
1
6
100万——200万（含200万）部分
0.75
