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海南省统计管理规定

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海南省统计管理规定

海南省人大常委会


海南省人民代表大会常务委员会

公告



第6号




《海南省统计管理规定》已由海南省第五届人民代表大会常务委员会第三次会议于2013年7月30日修订通过,现将修订后的《海南省统计管理规定》公布,自2013年9月1日起施行。



海南省人民代表大会常务委员会

2013年7月30日




海南省统计管理规定




(1997年10月24日海南省第一届人民代表大会常务委员会第三十二次会议通过 根据2004年9月24日海南省第三届人民代表大会常务委员会第十二次会议《关于修改〈海南省统计管理规定〉的决定》修正 2013年7月30日海南省第五届人民代表大会常务委员会第三次会议修订)




第一条 为了加强统计管理,保障统计资料的真实性、准确性、完整性和及时性,发挥统计在经济和社会发展中重要作用,根据《中华人民共和国统计法》和有关法律、行政法规,结合本省实际,制定本规定。



第二条 本规定适用于本省行政区域内各级人民政府、县级以上人民政府统计机构和有关部门组织实施的统计活动。



第三条 省人民政府统计机构负责组织、协调、指导和监督全省统计工作。



市、县、自治县人民政府统计机构负责组织、协调、指导和监督本行政区域内的统计工作。



国家统计局派出的调查机构依照国家规定的职能开展统计调查和统计监督。



第四条 县级以上人民政府及其有关部门应当加强对统计工作的领导,将统计工作纳入国民经济和社会发展规划,为统计工作提供必要保障。



第五条 省人民政府统计机构负责建设全省统计信息管理平台,实现部门统计信息互换和信息资源共享,推进统计信息搜集、处理、传输、存储技术和统计数据库体系的现代化。



县级以上人民政府统计机构应当制定统计信息安全应急处置预案,建立和完善统计资料灾难备份系统。



第六条 县级以上人民政府设立独立的统计机构。



乡镇人民政府、街道办事处设置统计工作岗位,配备专职统计人员,明确统计负责人,依法管理、开展统计工作,实施统计调查。配备专职统计人员确有困难的,经市、县、自治县人民政府同意,可以配备兼职统计人员,履行统计职责。



第七条 县级以上人民政府有关部门根据统计任务的需要设立统计机构,或者在有关机构中设置统计人员,并指定统计负责人,依法组织、管理本部门职责范围内的统计工作,实施统计调查,在统计业务上受本级人民政府统计机构指导。



第八条 村(居)民委员会应当配置统计协管员或者指定人员,开展统计工作。



各类园区、企业事业单位以及其他组织,应当根据统计任务的需要,明确相关机构承担统计工作,或者配置与统计任务相适应的统计人员,负责本单位的统计工作。



第九条 统计人员应当具备与其从事的统计工作相适应的专业知识和业务能力。



统计调查对象中承担经常性统计调查任务的单位,应当任用具有统计从业资格的人员从事统计工作。



县级以上人民政府统计机构和有关部门应当有计划地对统计人员进行培训,提高统计人员的职业道德素质和业务能力。



第十条 统计人员应当保持相对稳定。各级人民政府统计机构主要负责人、各部门和企业事业单位统计负责人,以及具有统计专业职称人员的调动,应当按照国家有关规定办理。



统计人员变动,应当及时补充并办理统计资料交接手续。



第十一条 县级以上人民政府统计机构应当根据需要设置统计检查机构或者配备统计执法人员,负责统计监督检查工作。



统计执法人员经考试合格取得执法资格后,方可从事统计监督检查工作。



第十二条 实施统计调查,应当遵循精简原则。通过行政记录能够满足需要的,不得组织实施统计调查;通过抽样调查、重点调查能够满足需要的,不得组织实施全面调查。



地方统计调查项目应当与国家统计调查项目、部门统计调查项目相衔接,不得重复;下级地方统计调查项目不得与上级地方统计调查项目重复;新增地方统计调查项目不得与原有地方统计调查项目重复。



第十三条 地方统计调查项目由县级以上人民政府统计机构和有关部门分别制定或者共同制定。



制定地方统计调查项目应当对其必要性、可行性、科学性进行论证,听取有关部门和专家的意见。



第十四条 制定统计调查项目,应当同时制定该项目的统计调查制度,并与该统计调查项目一并报经审批。



统计调查制度应当对调查目的、调查内容、调查方法、调查对象、调查组织方式、调查表式、统计资料的报送和公布等作出规定。



第十五条 地方统计调查项目按照下列权限报经审批:



(一)由省人民政府统计机构单独制定或者和有关部门共同制定的,报国家统计局审批;



(二)由市、县、自治县人民政府统计机构单独制定或者和有关部门共同制定的,报省人民政府统计机构审批;



(三)由县级以上人民政府有关部门制定的,报本级人民政府统计机构审批。



县级以上人民政府统计机构应当自受理地方统计调查项目申请之日起二十个工作日内作出决定,对符合条件的,作出予以批准的书面决定;对不符合条件的,作出不予批准的书面决定,并说明理由。



地方统计调查项目经批准后,统计机构和制定机关应当在其网站上公布。



第十六条 未按照规定的程序报经审批的统计调查表,任何单位和个人均有权拒绝填报;县级以上人民政府统计机构应当依法责令停止有关统计调查活动。



禁止利用统计调查窃取国家秘密、损害社会公共利益或者进行欺诈等违法活动。



第十七条 县级以上人民政府统计机构应当利用普查、基本单位调查和行政登记资料,按照统一标准建立、更新和维护基本单位名录库,实行动态管理。



县级以上人民政府统计机构应当根据基本单位名录资料及时书面告知统计调查对象领取统计报表。统计调查对象应当自收到告知书之日起十五个工作日内领取统计报表,并按照规定报送统计资料。



机构编制、民政、工商等部门应当按照国家和本省有关规定向同级人民政府统计机构提供基本单位行政登记资料。



第十八条 国家机关、企业事业单位、个体工商户以及其他组织和个人等统计调查对象,应当依照统计法律法规和统计调查制度的有关规定,真实、准确、完整、及时地提供统计调查所需的资料,不得迟报、拒报统计资料,不得提供不真实或者不完整的统计资料。



国家机关、企业事业单位或者其他组织作为统计调查对象提供统计资料,应当由填报人员及单位负责人在统计调查表上签字,并加盖公章。个人提供统计资料,应当由本人在统计调查表上签字。统计调查制度规定不需要签字、盖章的除外。



统计调查对象使用网络提供统计资料的,按照国家有关规定执行。



第十九条 县级以上人民政府统计机构、有关部门和统计人员应当按照经批准的统计调查制度组织实施统计调查活动,不得有下列行为:



(一)擅自变更统计调查制度的内容;



(二)伪造、篡改统计资料;



(三)以任何方式要求统计调查对象提供不真实的统计资料。



统计人员对其负责搜集、审核、录入的统计资料与统计调查对象报送的统计资料的一致性负责。



第二十条 各级人民政府、政府统计机构和有关部门以及各单位的负责人,不得有下列行为:



(一)自行修改统计机构和统计人员依法搜集、整理的统计资料;



(二)以任何方式要求统计机构、统计人员及其他机构、人员伪造、篡改统计资料;



(三)对依法履行职责或者拒绝、抵制、检举统计违法行为的统计人员进行打击报复。



第二十一条 县级以上人民政府统计机构、有关部门和乡镇人民政府统计人员,应当对统计调查对象提供的统计资料进行审核。需要订正的,应当由统计调查对象予以订正。



第二十二条 任何单位和个人不得转移、隐匿、篡改、毁弃统计原始记录、统计台帐和其他统计资料。



统计调查对象的原始记录和统计台帐,应当至少保存两年。县级以上人民政府统计机构和乡镇人民政府在统计调查中取得的汇总性统计资料应当至少保存十年。国家另有规定的,从其规定。



第二十三条 县级以上人民政府有关部门及中央、各省(自治区、直辖市)驻琼单位按照统计制度规定上报其主管部门的定期统计报表,应当同时报送当地人民政府统计机构备案。



第二十四条 县级以上人民政府统计机构按照国家有关规定定期公布统计资料;有关部门统计调查取得的统计资料由本部门依法公布。



县级以上人民政府有关部门在公布统计资料前应当抄送同级人民政府统计机构。其中,与同级人民政府统计机构统计调查取得的数据有重复、交叉的,应当就指标含义、调查方法和计算方法等与同级人民政府统计机构进行协商,未经协商一致的不得公布。



县级以上人民政府统计机构和有关部门公布统计资料时,应当对统计调查方法、调查对象和计算方法等作出说明。



尚未公布的统计资料,未经人民政府统计机构或有关部门批准,任何单位和个人不得擅自对外提供、泄露。



第二十五条 新闻、出版等单位采用政府统计机构或者有关部门公布的统计资料,内容上应当与其保持一致。



新闻、出版等单位采用政府统计机构或者有关部门尚未公布的统计资料,应当经统计机构或者有关部门审核同意,并注明资料来源。



第二十六条 县级以上人民政府统计机构和有关部门应当利用统计调查成果开展统计分析和监测预警,及时为政府决策提供服务。



县级以上人民政府统计机构和有关部门应当做好统计信息咨询服务工作,利用统计信息为社会公众服务。



单位和个人需要了解有关统计资料的,可以向统计机构和有关部门查询;统计机构和有关部门应当提供可以公开的统计资料,不得收取费用。



第二十七条 县级以上人民政府对经济效益、工作实绩进行考核评价,涉及现行统计指标的,应当统一使用经同级人民政府统计机构核准的统计数据。国家另有规定的除外。



考核评价对象应当建立健全考核评价指标的行政记录、原始记录和统计台帐,规范统计基础工作,保障考核评价指标数据真实准确。县级以上人民政府统计机构应当加强对考核评价统计数据质量的审核与评估。



任何单位和个人不得利用虚假统计资料骗取荣誉称号、物质利益或者职务晋升。



第二十八条 统计调查中获得的能够识别或者推断单个统计调查对象身份的资料,任何单位和个人不得对外提供、泄露,不得用于统计之外的目的,不得作为依照其他法律、法规对统计调查对象实施行政处罚的依据。



第二十九条 县级以上人民政府及其监察机关对下级人民政府、本级人民政府统计机构和有关部门执行本规定的情况实施监督。



县级以上人民政府统计机构有权对本行政区域内的统计调查对象进行监督检查,对统计数据进行稽查核实。有关单位和个人不得拒绝、阻碍检查。



第三十条 县级以上人民政府统计机构在监督检查工作中有权发出统计检查查询书,向被检查对象查询有关事项。被检查单位和个人应当自接到统计检查查询书之日起十五个工作日内作出答复。



第三十一条 县级以上人民政府统计机构依法查处本行政区域内的统计违法行为。市、县、自治县人民政府统计机构未按规定查处管辖范围内的统计违法行为,省人民政府统计机构应当责令其查处,必要时可以直接查处。



县级以上人民政府有关部门的统计违法行为,由同级人民政府统计机构查处;统计机构的统计违法行为,由上一级人民政府统计机构查处;人民政府的统计违法行为由上一级人民政府责成其统计机构查处或组织专门力量查处。



第三十二条 县级以上人民政府统计机构立案查处的重大统计违法行为,在立案的同时应当报上一级人民政府统计机构备案;处理结案后,应当向上一级人民政府统计机构报送处理结果。上级人民政府统计机构有权纠正下级人民政府统计机构对统计违法行为不适当的处理决定。



第三十三条 任何单位和个人有权检举统计中弄虚作假等违法行为。对检举有功的单位和个人应当给予表彰和奖励。



县级以上人民政府统计机构应当建立举报制度,公布举报电话号码、通信地址或者电子邮件信箱,及时受理公民、法人和其他组织对统计违法行为的检举,并依法查处违法行为。



第三十四条 对在统计工作中做出突出贡献、取得显著成绩的单位和个人,县级以上人民政府、县级以上人民政府统计机构和有关部门应当按照国家和本省有关规定给予表彰和奖励。



第三十五条 作为统计调查对象的国家机关、企业事业单位或者其他组织有下列行为之一的,由县级以上人民政府统计机构责令改正,给予警告,可以予以通报;其直接负责的主管人员和其他直接责任人员属于国家工作人员的,由任免机关或者监察机关依法给予处分:



(一)拒绝提供统计资料或者经催报后仍未按时提供统计资料的;



(二)提供不真实或者不完整的统计资料的;



(三)拒绝答复或者不如实答复统计检查查询书的;



(四)拒绝、阻碍统计调查、统计检查的;



(五)转移、隐匿、篡改、毁弃或者拒绝提供统计原始记录、统计台帐和其他统计资料的。



企业事业单位或者其他组织有前款所列行为之一的,可以并处五千元以上五万元以下的罚款;情节严重的,并处五万元以上二十万元以下的罚款。



个体工商户有本条第一款所列行为之一的,由县级以上人民政府统计机构责令改正,给予警告,可以并处一千元以上一万元以下的罚款。



第三十六条 作为统计调查对象的国家机关、企业事业单位或者其他组织有下列行为之一的,由县级以上人民政府统计机构责令改正,予以警告;其直接负责的主管人员和其他直接责任人员属于国家工作人员的,由任免机关或者监察机关依法给予处分:



(一)不按规定设置、保存、移交原始记录、统计台账的;



(二)未按规定领取统计报表的;



(三)安排未取得统计从业资格的人员承担经常性统计调查任务的。



企业事业单位或其他组织有前款违法行为之一的,可以并处一千元以上一万元以下的罚款。



第三十七条 县级以上人民政府有关部门未按照规定向统计机构提供基本单位行政登记资料的,由本级人民政府或者上级人民政府统计机构责令改正,予以通报。



第三十八条 县级以上人民政府有关部门未与同级人民政府统计机构协商一致公布本系统统计资料的,由本级人民政府或者上级人民政府统计机构责令改正,予以通报;对直接负责的主管人员和其他直接责任人员,由任免机关或者监察机关依法给予处分。



新闻、出版等单位未经核准,发表政府统计机构或者有关部门尚未公布的统计资料的,由县级以上人民政府统计机构给予警告;泄露国家秘密的,依照国家有关法律法规予以处罚。



第三十九条 县级以上人民政府统计机构和有关部门及其工作人员在统计工作中,滥用职权、玩忽职守、徇私舞弊、贪污受贿的,由任免机关或者监察机关依法给予行政处分;构成犯罪的,依法追究刑事责任。



第四十条 违反本规定的行为,本规定未设定处罚的,依照有关法律法规的规定处罚。



第四十一条 本规定自2013年9月1日起施行。


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教育部关于国家职工在校学习期间工龄计算问题的复函

教育部


教育部关于国家职工在校学习期间工龄计算问题的复函
教育部

复函
陕西师范大学:
一九八○年四月五日师大校发(80)098号函悉。
关于国家职工在享受劳动保险待遇时,其在高等学校学习期间的工龄计算问题,经与国家劳动总局研究,现综合答复如下:
一、一九七○年以前进入高等和中等专业学校学习的国家职工,在学习期间的工龄计算,仍按原劳动部工资局一九六二年十月十三日(62)中劳薪字第292号文件执行,即:“由于工作需要经行政上调派到各类学校学习,在学习期间照发原工资的,其学习期间及调派学习前后的连
续工龄,可以合并计算为连续工龄”。“由本人申请经领导批准离职考入各类学校学习,学习期间由学校发给助学金的,学习期间不能计算为工龄,其学习前后的连续工龄,可以合并计算为连续工龄”。
二、一九七○年至一九七八年进入高等院校,中等专业学校和技工学校学习的国家职工工龄计算,应按国务院国发〔1973〕39号,81号文件及一九七七年十一月十一日教育部、财政部、国家劳动总局(77)教计字420号、(77)财事字365号、(77)劳薪字369
号文件执行,即:“国家职工,进入高等学校和中等专业学校学习,……其学习时间,都应计算为连续工龄”。
三、一九七九年以后考入普通高等学校本、专科学习的国家职工,其工龄计算,按一九七九年八月四日教育部、财政部、国家劳动总局(79)教计字315号、(79)财事字194号、(79)劳总薪字69号文件执行,即:“考入普通高等学校的国家职工在校学习期间一律不计
算工龄。入学前和毕业后参加工作的连续工龄可以合并计算”。
四、原国家计委劳动局一九七二年七月二十一日(72)计劳业字35号文及国家劳动总局一九七七年十月二十六日(77)劳薪字137号文规定的职工在校学习期间计算工作年限的办法,当时已明确规定只适用于那两次调整工资,因此,不得作为计算职工各项劳动保险待遇的依据




1980年7月19日

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.






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