苏州市人民政府办公室关于转发苏州市食品安全工作综合评价暂行办法的通知
江苏省苏州市人民政府办公室
苏州市人民政府办公室关于转发苏州市食品安全工作综合评价暂行办法的通知
苏府办〔2006〕24号
各市、区人民政府，苏州工业园区、苏州高新区管委会；市各委办局（公司），各直属单位：
经市政府同意，现将市食品安全委员会办公室制定的《苏州市食品安全工作综合评价暂行办法》转发给你们，请认真贯彻执行。
苏州市人民政府办公室
二○○六年三月三日
苏州市食品安全工作综合评价暂行办法
第一条为切实加强全市食品安全工作，强化监督，落实责任，深入推进食品放心工程，努力创建食品放心消费环境，根据《国务院关于进一步加强食品安全工作的决定》（国发〔2004〕23号）、《省政府关于进一步加强食品安全工作的意见》（苏政发〔2005〕10号）、国家食品药品监督管理局等八部门制定的《实施食品放心工程综合评价办法（试行）》（国食药监察〔2004〕442号）和苏州市政府《关于进一步加强全市食品安全工作的意见》（苏府〔2005〕98号），结合我市实际，制定本办法。
第二条本办法适用于全市各级人民政府对下级人民政府、同级政府有关部门食品安全工作的评价，评价工作经市政府授权，由苏州市食品安全委员会具体组织实施。
第三条食品安全工作综合评价以实事求是、客观公正、以评促管、激励引导为原则，坚持宣传教育与考核监督相结合，责任落实与责任追究相结合。
第四条食品安全工作综合评价指标分为管理性指标和绩效性指标，管理性指标主要评价政府责任落实、管理体系建立健全、各项治理措施的实施情况；绩效性指标主要评价各项预定目标的完成情况。
第五条评价采取评分制，满分100分，其中管理性指标60分，绩效性指标40分。采用逐项扣分办法，每项扣分直至该项标准分扣完为止。
第六条每项评价项目分为A、B、C、D四等，权重分别为1.0、0.8、0.6和0，具体得分为项目标准值乘以权重。
第七条评价结果分为优秀、良好、合格、不合格四个等次。地区评价按总分数进行评定，得分在90分以上（含90分）的为优秀，80～90分（含80分）的为良好，60～80分（含60分）的为合格；低于60分的为不合格。部门评价应按应评价项目得分占应评价项目总分的比例确定等次。评价得分比重在90%（含90%）以上的为优秀，80%～90%（含80%）的为良好，60%～80%（含60%）的为合格，低于60%的为不合格。
第八条有下列情形之一的地区，实行一票否决，年度评价为不合格。
（一）发生重、特大食品安全事故的；
（二）发生食品安全事故隐瞒不报或弄虚作假，或对事故处置不力，造成事故影响扩大、人员和财产损失增加的；
（三）发生重大食品质量问题，被全国性媒体曝光或国家有关部门查处，并造成严重社会影响的。
第九条有下列情形之一的地区，年度评价扣除绩效分20～40分。
（一）发生较大食品安全事故的；
（二）发生食品质量问题，被省内媒体曝光或省有关部门查处，并造成较大社会影响的；
（三）区域性食品安全问题长期得不到解决，并造成不良社会影响的。
第十条综合评价采取自查自评与组织评价、日常评价与年度评价、随机评价与安排评价相结合的方式。每年年末，各市、区人民政府和苏州市有关部门应将本年度食品安全工作自评结果书面报苏州市人民政府和苏州市食品安全委员会。
第十一条评价工作一般在年末进行；评价小组由市食品安全委员会成员单位及有关专家组成。
第十二条评价工作按以下程序进行：被评价单位自查总结，向评价组汇报，评价组查看相关记录及档案资料，实地考查，询访基层相关人员及消费者，综合评价组成员意见，确定评价结论，评价组长签字，评价材料报送市食品安全委员会。
第十三条市食品安全委员会将综合评价结果上报市人民政府，同时书面通知被评价单位。
第十四条经市人民政府同意，市食品安全委员会对评价结果为优秀和良好的地区和单位予以通报表彰；对评价结果为不合格的地区和单位，予以通报批评并提出限期整改意见。
第十五条本办法由苏州市食品安全委员会办公室负责解释。
第十六条本办法自下发之日起施行。
附件：苏州市食品安全工作综合评价实施细则
苏州市食品安全工作综合评价实施细则
评价内容
评价项目
计分标准
评价基准
内涵说明
评价等次
实际得分
A（1.0）
C（0.6）
一、政府责任落实、管理体系建设情况（10分）
1.1政府责任落实 1.食品安全工作有部署，有要求，有检查，有考核 0.5 部署、要求明确 部署、要求不明确
列入政府议事日程，定期召开会议，听取有关部门汇报，了解检查进展，研究部署工作，及时协调解决食品安全工作中的问题。
2.领导重视 0.5
领导明确，工作到位，力度大
无专人分管，工作力度不够
分管领导明确，工作情况熟悉。
3.分工明确，建立了工作责任制度
0.5
责任分工明确
责任分工不够明确
职责分工明确，建立了食品安全工作目标责任制，并纳入政绩考核内容。
4.监管保障措施到位
0.5
人员、机构、经费三到位
人员、机构、经费基本到位
相关监管机构、职能、人员及配备条件与所承担的工作相适应；经费列入年度财政预算。
1.2部门职能到位 1.部门领导重视
0.5
领导重视
重视不够
各部门领导对工作目标措施、进度情况熟悉，食品安全职能落实到位好。
2.部门职能落实
0.5
职能到位好
职能基本到位
部门职能落实到位，有专人负责，职能履行较好。
3.工作有计划、有目标，措施得力
0.5
食品安全工作列入部门重点工作
食品安全工作不突出，未专门部署
根据本部门职能，制定了工作计划、方案，任务明确、具体，措施有力。
4．重要事项通报及时
0.5
重要事项及时通报
重要事项通报不够及时
及时通报食品安全工作计划、方案及重大活动等信息，定期报告食品阶段性工作，按时报送统计报表，适时报送监管动态。
1.3工作协调配合机制建立情况 1．综合协调机制形成
0.5
建立了协调机制
基本建立
建立了政府层面的组织协调机构，定期召开协调会议，研究问题，通报情况，部署任务。
2．部门协调、配合、联络制度建立
0.5
互相配合，形成合力
配合还有差距
各部门有大局意识、责任意识、协作意识，部门配合较好。
3．执法行为规范
0.5
执法行为规范，部门协调，企业反映好
行为不够规范，部门协调有一定差距，企业反映一般
执法行为规范，避免重复抽检，提高监管水平、效率，探讨执法联动机制有创新。
4．检测资源整合
0.5
资源得到整合，作用充分发挥
检测机构作用发挥不够
检测资源整合较好，条件互补，资源共享，检测机构条件和水平能保证当地食品安全监管工作的需要。
1.4制度保障 1．食品安全监管信息综合利用
0.5
信息整合好，信息共享
信息整合差，不能共享
建立了食品安全监管信息报告、通报、分析、共享、预警、发布制度和体系，能按要求定期或不定期发布食品安全信息。
2．重大食品安全事故应急预案制定
0.5
预案完备
预案不够完备
制定了重大食品安全事故应急预案，内容详细、周密，可操作性强。
3．重大食品安全事故责任追究制度建立
0.5
建立，明确，落实好
建立，但不够明确
建立了重大食品安全事故责任追究制度。
4．监管制度建设
0.5
有制度，有创新，成效显著
有制度，但创新较差，成效不显著
不断建立和完善食品安全监管制度，有特色、有创新，并取得成效。
1.5综合监管部门作用 1．组织协调工作到位
0.5
协调力度大，工作落实到位
协调工作落实不够到位
部门协调机制落实得好，及时召开部门协调会议，研究问题，及时通报情况，交流信息。
2．牵头部门履行职责情况
0.5
牵头作用发挥好
牵头作用发挥一般
牵头部门履行职责，组织协调工作到位，注重调查研究，主动发现问题，及时提出解决方案（措施）。
3．主动查处重大食品安全事故情况
0.5
事故查处及时，处理到位
组织查处重视不够，处理不到位
主动牵头组织开展重大食品安全事故查处工作。
4．重大食品安全事故报告制度
0.5
报告制度完备，报告及时
有报告制度，报告不够及时
重大食品安全事故信息及时向政府和上级部门报告。
二、监管措施落实情况（50分）
2.1种植养殖环节监管 1．开展农业投入品整治行动
2
整治行动有力，成效显著
整治工作力度不大，成效不明显
积极开展农业投入品整治行动，种植养殖业产品农药滥用，畜产品、水产品违禁药物滥用和药物残留超标得到有效控制。
2．加强无公害农产品生产基地建设
1
基地建设不断增强
基地建设缓慢
推进无公害农产品标准化生产综合示范区、养殖小区、示范农场、无规定动物疫病区和出口产品生产基地的建设，推广“公司+基地”模式，加快对高毒、高残留农业投入品禁用、限用和淘汰进程。
3．积极开展“三品”认证和产地认定
1
“三品”、产地认证认定成效显著
成效不明显
积极开展无公害农产品、绿色食品、有机食品认证和无公害农产品产地认定。
4．加强农业标准化建设
2
标准制定与实施步伐大，成效明显
标准制定与实施完善成效不明显
加快推进标准化建设步伐，不断完善食品标准，逐步建立统一规范的农产品质量安全标准与检测体系。
5．不断完善日常监管制度
1
日常监管制度不断完善，并得到落实
监管力度不够，源头整治不明显
建立农产品质量安全例行监测制度和农产品质量安全追溯制度，开展农产品产地环境、农业投入品和农产品质量安全状况的检测。
2.2食品生产加工环节监管 1．开展无证照食品加工点的整治
2
打击措施具体，整治有力度
打击措施不够具体，整治力度小
开展无卫生许可证、无营业执照、无生产许可证的生产加工行为的整治，无证生产行为得到有效遏制。
2．开展滥用食品添加剂、非食用原料加工食品的整治
1
打击措施具体，整治有力度
打击措施不够具体，整治力度小
开展新资源食品、食品添加剂和食品包装材料等的安全性评价和整治，滥用添加剂、使用非食品原料生产加工食品、保健食品添加违禁药物等违法行为得到有效遏制。
3．加强畜禽屠宰管理，规范肉品加工经营行为
1
定点规范屠宰，合格上市
基本规范，仍存在一定隐患
城市基本实现生猪定点屠宰，基本消除注水肉、病畜肉上市，牛、羊、禽类定点屠宰积极推进。
4．严格实施食品质量安全准入制度
1
准入制度执行严格
准入制度执行一般
严格依法审查企业生产条件，严格按标准组织生产，严格产品出厂检验，按照统一要求的进度完成准入任务。
5．落实日常监管制度
1
日常监管措施到位，监管严格
日常监管措施落实存在差距
建立了生产企业巡查、回访、年审、监督抽查等日常监管制度并得到落实。
2.3食品流通环节监管 1．加强现代市场体系建设，改善食品流通、经营方式
1
绿色市场建设推进有力，成效好
绿色市场建设推进步伐缓慢
积极实施“三绿工程”，倡导现代流通组织方式和经营方式，大力发展连锁经营和物流配送。
2．严格食品经营主体资格审查制度
1
严格审查，持证率高
审查不严，无证经营行为较多
依法严格审查食品生产、经营企业及个体工商户的主体资格，严格执行前置审批规定。
3．推进食品市场农产品质量检测体系建设
1
建设步伐快，效果好
建设步伐缓慢
农副产品市场实施“肉菜粮放心工程”覆盖面、检测设备配备率和检测实施率不断提高。
4．指导流通企业建立健全“六项”制度
1
“六项”制度健全，执行严格
制度不够完善，执行不够到位
建立健全进货检查验收制度，索证索票制度，购销台帐制度，销售食品质量安全承诺制度，“厂场挂钩”、“场地挂钩”等协议准入制度，不合格食品退市、召回等六项制度，效果显著。
5．落实市场开办者的食品质量监管责任
1
责任落实较好
责任不够落实
市场开办者落实对进场经营者的资格审查责任；对进场经营者的食品质量监督管理责任；对进场经营者的教育引导责任；建档备案和协助执法部门监督检查的责任。
6．全面落实日常监管四项制度
1
四项制度落实较好
四项制度落实不够到位
全面落实市场巡查制度，完善监督抽查和食品卫生例行监测制度，严格实行不合格食品的退市、召回、销毁制度，建立食品质量信息公布制度。
7．严查过保质期食品，打击“三无”行为
1
市场检查无“三无”、过期食品
市场检查“三无”、过期食品少量存在
严查市场无生产日期、无保质期、无厂名“三无”食品，不合格食品退市制度全面建立。
2.4食品消费环节监管 1．开展无证照餐馆整治
1
无证照经营现象消除
无证照经营现象基本消除
开展无证照餐馆整治、无证经营现象得到有效遏制。
2．强化对餐饮业、学校食堂和建筑工地食堂的卫生检查监督
2
无重大食品安全事故隐患
食品卫生安全仍有隐患
学校、建筑工地食堂饮食卫生监管得到有效加强。
3．加强对散装食品卫生监督检查
1
符合规范
基本符合规范
执行散装食品卫生规范。
4．实现食品卫生监督量化分级管理
1
量化分级管理成效显著
量化分级管理工作进展迟缓
积极推进食品卫生监督量化分级管理制度，提高日常监管的质量和效率。
5．开展食品污染物监测
1
开展监测情况较好
开展监测情况一般
完善和加强食品污染物监测，建立食品安全预防预警体系。
2.5重点专项整治 1．开展儿童食品整治活动
2
整治工作成效显著
整治工作成效一般
儿童食品整治有措施、有成效，劣质奶粉在市场上基本消除；儿童食品添加剂的使用得到有效规范。
2．开展“三假”、“三无”食品整治活动
2
有效遏制，现场检查未发现
基本遏制，少量存在
打击“假包装、假标识、假商标”及“无生产日期、无保质期、无厂名”食品有力度，整治成效显著。
3．强化农村及城乡结合部食品市场整治
2
监管到位，成效显著
监管不够到位，整治成效不明显
将监管的重点和工作重心下移，建立了农村食品安全监管网络，加大对分散在社区、城乡结合部和村镇的各类食品批发市场、集贸市场、个体商贩、小加工作坊、小食品店、小餐馆的监管力度，假冒伪劣食品得到有效控制。
2.6积极推进食品安全信用体系建设 1．认真开展试点工作
2
政府、部门重视，试点工作进展顺利
政府、部门重视不够，试点工作进度迟缓
政府、部门对信用体系建设工作重视，有试点方案，并积极推进。
2．加强食品安全信用基础工作
2
基础工作扎实推进
工作进度迟缓
企业积极建立食品生产经营档案；监管部门建立食品安全监管信用信息记录和档案制度，并积极组织实施。
3．积极建立完善各项制度
2
不断建立完善
制度不够完善
积极探索，不断创新，建立规范、制度，食品安全信用激励惩戒机制基本形成。
2.7 食品安全案件查处到位 1．建立食品安全案件快速反应机制
2
认真受理，处理及时
案件受理查办不及时
对于投诉举报以及媒体曝光的食品安全事件，作出快速反应，迅速开展调查、处理，并及时反馈、报告调查处理结果。
2．大案要案查处情况
2
查处力度大，及时查办
案件受理、查办不及时，处置不严格
对大案要案受理快，查办及时，处理严格。
3．大案要案移送情况
2
移送及时
移送不及时
案件查处中，部门协调配合好，非管辖案件及时移交有关部门处理。
2.8宣传教育到位 1．开展宣传活动
1
形式多样，成效显著
形式单一，效果一般
利用各种形式，广泛宣传实施食品放心工程的重要意义、内容、措施。
2．开展培训教育
1
培训任务落实，效果好
教育培训覆盖面小，效果差
加强对管理相对人的教育培训，强化食品加工经营企业是食品安全第一责任人的意识。加强对监管队伍人员的培训，提高行政执法能力和水平。
3．普及食品安全知识
1
食品安全普及知识宣传较好
普及知识宣传少，消费者了解少
利用各种形式，宣传群众，教育群众，使广大消费者增加食品安全知识，树立自我保护意识。
4．建立信息发布和宣传报道制度
1
及时发布监管有关信息，宣传报道到位
信息发布不及时，报道少
监管部门及时公布食品安全信息，重大食品安全事故及时曝光；建立了与媒体之间的信息沟通制度，媒体能积极、客观、及时报道食品放心工程实施情况。
2.9食用农产品种植养殖环境保护 1．建立健全食用农产品基地环境安全预警与应急体系
1
体系完善，预警与应急能力强，全天候运行
体系基本完善，预警与应急能力较强，运行基本正常
从装备到能力建设完善，确保全天候运行。
2．建立健全食用农产品基地环境质量监测监管体系
1
基地环境质量监测监管网络健全，保证日常运行
基地环境质量监测监管网络基本健全，基本保证日常运行
“硬件”和“软件”都齐备，确保日常运行正常。
三、绩效目标实现情况（40分）（下列指标为参考项目，以当年制定的目标为准进行考核）
3.1治理成果 1．全市蔬菜农药残留检测合格率
3
达到和超过预期目标值
与目标差距较远，低于目标值5%以内
有关检测指标按国家、省级以上部门年度监测、抽检情况进行评价。
2．生猪及其产品中违禁药物检出率
3
达到和超过预期目标
微量超标
3．水产品药物残留检测合格率
3
达到和超过预期目标
微量超标
4．无公害农产品生产基地面积
3
达到和超过预期目标
低于目标值5%以内
5．重点产品质量检测覆盖面
10
国家规定的重点检测品种全部覆盖
少数品种项目开展检测
6．加工食品质量抽查合格率
3
达到和超过预期目标
低于目标值5%以内
7．食品质量卫生安全投诉事件投诉处理率
3
及时处理，处理率95%以上
处理不够及时，处理率85%以上
8．集体食物中毒数量
6
有效控制，未增加
发生起数较上年上升5%以上0分
9．农副产品市场实施“肉菜粮放心工程”覆盖面、检测设备配备率和检测实施率
3
实施面增长10%以上
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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.