关于下发《国家海洋局机关、事业单位工人技术等级考核实施办法》的通知
国家海洋局
关于下发《国家海洋局机关、事业单位工人技术等级考核实施办法》的通知
1995年2月20日，国家海洋局
局属各单位：
现将《国家海洋局机关、事业单位工人技术等级考核实施办法》下发给你们，请遵照执行。
国家海洋局机关、事业单位工人技术等级考核实施办法
根据《机关、事业单位工人技术等级岗位考核暂行办法的通知》 （人薪发〔1994〕50号） 和《关于印发＜中央国家机关工人技术等级考核实施办法＞（试行）的通知》〔94〕国管体改字第172号），并依据《工人考核条例》的有关规定，特制定本实施办法。
一、 考核范围
局属各单位除普通船员以外，机关事业单位在岗技术工人(含合同制技术工人， 下同)， 列入工人技术等级考核范围。
二、考核内容
1、思想政治表现：遵守国家宪法、法律和政策，遵守局和所在单位的规章制度，有良好的职业道德，劳动态度端正。
2、生产工作成绩：完成生产工作任务的数量、质量和安全生产情况；生产工作中从事技术革新和解决技术问题的能力。
3、技术业务水平：技术业务理论和实际操作技能。
三、考核方式及原则
（一）考核方式
1、分为本等级考核和升级考核两种。
2、思想政治表现和生产工作成绩的考核结果分合格、不合格两种。
3、技术业务水平考核接百分制计分，技术业务理论考核和操作技能考核均达到规定分数者为合格。
4、思想政治表现、生产工作成绩、技术业务水平三项考核成绩全部合格者即为考核合格。
（二）考核原则
1、必须分级考核，按级取证。
2、符合《工人考核条例》的要求，培训和考核相结合。
3、严格标准，保证质量，实事求是，不弄虚作假。
4、符合申报条件。
四、技术等级考核的申报条件
（一） 本等级考核
1993年10月1日以前未取得《技术等级证书》的，均先参加本等级考核；申报年限计算到1993年9月30口。
1、在本工种工作学徒期、熟练期已满者，可申报初级工的考核
2、从事本工种工作10年以上或工作15年以上并在本工种工作5年以上者，可申报中级工的考核。
3、从事本工种工作20年以上或工作25年以上并在本工种工作12年以上者，可申报高级工的考核。
（二） 升级考核
对已取得技术等级证书者按下列条件参加升级考核
1、持初级工证书的3年以上，且工作10年以上，可申报中级工考核。
2、持中级工证书5年以上，且工作20年以上者，可申报高级工的考核。
五、 组织实施
（一）思想政治表观和生产工作成绩的考核，由所在单位和部门根据相应考核内容，采取日常和定期考核相结合的方式进行考评。
（二） 技术业务水平考核
1、海洋行业17个技术工种工人的培训考核工作，由局统一组织实施。
2、非海洋行业技术工种工人的培训考核工作，由所在地政府人事劳动部门或人事部、劳动部授权的工种所属行业主管人事劳动部门组织实施。
六、申报程序
1、需参加技术等级考试者，先由本人以书面形式提出申请，申请应写明所报考工种、等级、参加工作时间、本工种工作时间及原技术等级情况，还应就思想政治表现和生产工作情况做自我鉴定。
2、根据本人申请，由所在单位人事、劳资部门依实际情况填写《国家海洋局工人技术等级考核审批表》。对符合申报条件，思想政治表观及生产工作成绩两项考评合格的，出具证明参加技术业务水平考试。
七、证书认定及工资待遇
（一） 证书认定
按《国家海洋局工人技术等级考核审批表》考核合格并持有人事部或劳动部统一印剧的《技术等级证书》者，所持《技术等级证书》有效。
（三） 工资待遇
对持有效《技术等级证书》者，按以下办法兑现工资。
1、1993年10月1日以后取得《技术等级证书》的按国办发（1993）85号文兑现技术等级工资及相应津贴。并按国海人发（1994）305号文补发工资。
2、参加升级考核取得《技术等级证书》的按国海人发（1995）068号文兑现工资。
八、本实施办法由国家海洋局劳动人事教育司负责解释。
国家海洋局工人技术等级考核审批表
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┃单 位│ │姓 名 │ │性 别 │ │出生年月│ ┃
┠───┴──┬┴────┴─┬─┴────┴─┬┴────┴────┨
┃参加工作时间│ │本工种工作时间 │ ┃
┠──┬───┼────┬──┴─┬──────┴┬─────────┨
┃工种│ │申报等级│ │已有技术等级 │ ┃
┠──┴───┴─┬──┴───┬┴───────┴──┬──────┨
┃已有等级证书号码│ │已有等级证书考取时问 │ ┃
┠────────┴──────┴───────────┴──────┨
┃ 工 种 变 动 简 历 ┃
┠─────┬─────┬───────┬──────┬───────┨
┃年 月 │ 单 位 │ 工 种 │ 证 明 人 │ ┃
┠─────┼─────┼───────┼──────┼───────┨
┃ │ │ │ │ ┃
┃ │ │ │ │ ┃
┃ │ │ │ │ ┃
┃ │ │ │ │ ┃
┠─────┴──┬──┼───────┴──────┴───────┨
┃思想政治表现考评│ │ 注：填 合格或不合格 ┃
┠────────┴──┴──────────────────────┨
┃评语： ┃
┃ ┃
┃ ┃
┃ ┃
┃ ┃
┃ ┃
┃ 部门领导签字： 年 月 日 ┃
┗━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━┛
┏━━━━━━━━━┯━━━━┯━━━━━━━━━━━━━━━━━━━┓
┃生产工作成绩考评：│ │注：填合格或不合格 ┃
┠─────────┴────┴───────────────────┨
┃ 评语： ┃
┃ ┃
┃ ┃
┃ ┃
┃ ┃
┃ 部门领导签字： 年 月 日 ┃
┠──────────────────────────────────┨
┃单位领导评语及考评意见： ┃
┃ ┃
┃ ┃
┃ ┃
┃ ┃
┃ ┃
┠──────────┬───┬───────────┬───────┨
┃技术业务理论考核成绩│ │实 际 操 作 成 绩│ ┃
┠─────────┬┴──┬┴───────────┴──┬────┨
┃单位考核定级意见 │ │人 事 部 门 考 核 定 级 意 见 │ ┃
┠─────────┴───┼───────────────┴────┨
┃ │ ┃
┃ │ ┃
┃ │ ┃
┃ 盖 章 │ 盖 章 ┃
┃ │ ┃
┃ 年 月 日 │ 年 月 日 ┃
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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.
