证券公司分类监管规定（2010年修订）
中国证券监督管理委员会
证监会公告[2010]17号——关于修改《证券公司分类监管规定》的决定
中国证券监督管理委员会公告
〔2010〕17 号
现公布《关于修改〈证券公司分类监管规定〉的决定》，自公布之日起施行。
中国证券监督管理委员会
二○一○年五月十四日
附件1：关于修改《证券公司分类监管规定》的决定.doc
附件2：证券公司分类监管规定（2010年修订）.doc
证券公司分类监管规定（2010年修订）
第一章 总则
第一条 为有效实施证券公司常规监管，合理配置监管资源，提高监管效率，促进证券公司持续规范发展，根据《证券法》、《证券公司监督管理条例》等有关法律、行政法规的规定，制定本规定。
第二条 证券公司分类是指以证券公司风险管理能力为基础，结合公司市场竞争力和持续合规状况，按照本规定评价和确定证券公司的类别。
中国证监会根据市场发展情况和审慎监管原则，在征求行业意见的基础上，制定并适时调整证券公司分类的评价指标与标准。
第三条 中国证监会及其派出机构根据证券公司分类结果对不同类别的证券公司实施区别对待的监管政策。
第四条 证券公司的分类由中国证监会及其派出机构组织实施。
中国证监会在分类复核中建立专家评审机制，组成专家评审委员会，研究处理证券公司分类工作中遇到的重大问题。专家评审委员会的成员由中国证监会及其派出机构、证券行业自律组织、证券公司有关人员组成。
证券公司分类工作必须坚持依法合规、客观公正的原则。参与证券公司分类工作的人员应当具备相应的专业素质、业务能力和监管经验，在工作中坚持原则、廉洁奉公、勤勉尽责。
第二章 评价指标
第五条 证券公司风险管理能力主要根据资本充足、公司治理与合规管理、动态风险监控、信息系统安全、客户权益保护、信息披露等6类评价指标，按照《证券公司风险管理能力评价指标与标准》（见附件）进行评价，体现证券公司对流动性风险、合规风险、市场风险、信用风险、技术风险及操作风险等管理能力。
（一）资本充足。主要反映证券公司净资本以及以净资本为核心的风险控制指标情况，体现其资本实力及流动性状况。
（二）公司治理与合规管理。主要反映证券公司治理和规范运作情况，体现其合规风险管理能力。
（三）动态风险监控。主要反映证券公司风险控制指标及各项业务风险的动态识别、度量、监测、预警、报告及处理机制情况，体现其市场风险、信用风险的管理能力。
（四）信息系统安全。主要反映证券公司IT 治理及信息技术系统运行情况，体现其技术风险管理能力。
（五）客户权益保护。主要反映证券公司客户资产安全性、客户服务及客户管理水平，体现其操作风险管理能力。
（六）信息披露。主要反映证券公司报送信息的真实性、准确性、完整性和及时性，体现其会计风险及诚信风险管理能力。
第六条 证券公司市场竞争力主要根据证券公司经纪业务、承销与保荐业务、资产管理业务、成本管理能力、创新能力等方面的情况进行评价。
第七条 证券公司持续合规状况主要根据司法机关采取的刑事处罚措施，中国证监会及其派出机构采取的行政处罚措施、监管措施及证券行业自律组织纪律处分的情况进行评价。
第三章 评价方法
第八条 设定正常经营的证券公司基准分为100分。在基准分的基础上，根据证券公司风险管理能力评价指标与标准、市场竞争力、持续合规状况等方面情况，进行相应加分或扣分以确定证券公司的评价计分。
第九条 评价期内证券公司因违法违规行为被中国证监会及其派出机构采取行政处罚措施、监管措施或者被司法机关刑事处罚的，按以下原则给予相应扣分：
（一）公司被采取出具警示函，责令公开说明，责令参加培训，责令定期报告，责令增加内部合规检查次数的，每次扣1分；
（二）公司被采取出具警示函并在辖区内通报，责令改正，责令处分有关人员，或者董事、监事、高级管理人员因对公司违法违规行为负有责任被监管谈话的，每次扣1.5分；
（三）公司被采取出具警示函并在全行业通报，责令停止职权或解除职务，责令更换董事、监事、高级管理人员或限制其权利，限制股东权利或责令转让股权的，每次扣2分;
（四）公司被采取公开谴责，限制业务活动，暂不受理与行政许可有关文件，暂停核准新业务或增设、收购营业性分支机构申请的，每次扣2.5分；
（五）董事、监事、高级管理人员因对公司违法违规行为负有责任被认定为不适当人选或被撤销任职资格的，每次扣3分；
（六）公司被采取警告行政处罚措施，或者董事、监事、高级管理人员因对公司违法违规行为负有责任被采取警告行政处罚措施的，每次扣4分；
（七）公司被采取罚款行政处罚措施，或者董事、监事、高级管理人员因对公司违法违规行为负有责任被采取罚款行政处罚措施的，每次扣5分；
（八）公司被采取没收违法所得行政处罚措施，或者董事、监事、高级管理人员因对公司违法违规行为负有责任被采取没收违法所得行政处罚措施的，每次扣6分；
（九）董事、监事、高级管理人员因对公司违法违规行为负有责任被采取一定期限内市场禁入，每次扣7分；
（十）公司被采取暂停业务许可行政处罚措施，或者董事、监事、高级管理人员因对公司违法违规行为负有责任被采取永久性市场禁入的，每次扣8分；
（十一）公司被采取撤销部分业务许可行政处罚措施或被刑事处罚的，每次扣10分。
证券公司分公司、营业部等分支机构被直接采取上述措施的，按以上原则减半扣分，累计最高扣5分；证券公司分支机构负责人等管理人员、保荐代表人等主要业务人员因对公司及分支机构违法违规行为负有责任被直接采取上述措施的，按以上原则减半扣分，累计最高扣5分；证券公司控股子公司纳入母公司合并评价的，子公司被采取的监管措施，按以上原则减半扣分。
第十条 证券公司被证券行业自律组织纪律处分的，每次扣0.5分。
第十一条 就同一事项对证券公司采取多项行政处罚措施、监管措施、纪律处分的，按最高分值扣分，不重复扣分，但因限期整改不到位再次被采取行政处罚措施、监管措施、纪律处分的除外；就不同事项采取同一行政处罚措施、监管措施、纪律处分的，应当分别计算、合计扣分。
证券公司因同一事项在不同评价期被分别采取行政处罚措施、监管措施、纪律处分的，按最高分值扣分；同一事项在以前评价期已被扣分但未达到最高分值扣分的，按最高分值与已扣分值的差额扣分。
第十二条 证券公司资本充足、公司治理与合规管理、动态风险监控、信息系统安全、客户权益保护和信息披露等6类评价指标存在一定问题，按具体评价标准每项扣0.5分。如已被采取监管措施的，按本规定第九条执行，不重复扣分。
第十三条 证券公司市场竞争力符合以下条件的，按以下原则给予相应加分：
（一）证券公司上一年度代理买卖证券业务净收入或营业部平均代理买卖证券业务净收入位于行业前5名、前10名、前20名的，分别加2分、1分、0.5分；
（二）证券公司上一年度承销与保荐业务、并购重组等财务顾问业务净收入或股票主承销家数或债券主承销家数位于行业前5名、前10名的，分别加2分、1分；
（三）证券公司上一年度资产管理业务净收入位于行业前5名、前10名、前20名的，分别加2分、1分、0.5分；
（四）证券公司上一年度净利润为正且成本管理能力位于行业前5名、前10名、前20名的，分别加2分、1分、0.5分；
（五）证券公司创新成果评价期内在行业推广的，单项或累计最高可加5分。
证券公司在评价期内如因违法违规行为被采取本规定第九条第（六）至第（十一）项措施的，不适用本条第（一）至第（三）项加分。
证券公司在评价期内发生未履行上市保荐和持续保荐法定职责与义务情形的，不适用本条第（二）项加分。
第十四条 证券公司符合以下条件的，按以下原则给予相应加分：
（一）公司最近2个、3个评价期内主要风险控制指标持续达标的，分别加2分、3分；
（二）公司最近2个、3个评价期内未被采取过本规定第九条第（六）至第（十一）项措施的，分别加2分、3分；
（三）公司净资本达到规定标准5倍及以上的，每一倍数加0.1分，最高可加3分；
（四）公司净资本与负债的比例、净资本与各项风险资本准备之和的比例达到规定标准2倍及以上的，分别加0.5分；
（五）净资本收益率位于行业前5名、前10名、中位数以上的，分别加2分、1分、0.5分。
第十五条 中国证监会及其派出机构可以根据证券公司在评价期内落实专项监管工作情况，对证券公司的评价计分进行调整，每项最高可加或扣3分。
第十六条 证券公司可以申请中国证监会认可的机构（以下简称专业评价机构）组织专家对其专业管理能力、信息技术系统的稳定与安全、客户服务与管理水平、投资者教育等方面进行专业评价；专业评价机构可针对证券行业内发生的重大事故、技术故障、业务纠纷与客户投诉等情况，对涉及的证券公司进行专业评价。证券公司专业评价的标准和办法另行制定。
中国证监会及其派出机构可以根据证券公司专业评价结果，对证券公司评价计分进行调整，每项专业评价最高可加3分。
经专业评价机构评定，证券公司发生的重大事故、技术故障、业务纠纷、客户投诉是由于证券公司管理不善引起的，中国证监会及其派出机构应采取相应的监管措施，进行扣分。
第四章 类别划分
第十七条 中国证监会根据证券公司评价计分的高低，将证券公司分为A（AAA、AA、A）、B（BBB、BB、B）、C（CCC、CC、C）、D、E等5大类11个级别。
被依法采取责令停业整顿、指定其他机构托管、接管、行政重组等风险处置措施的证券公司，评价计分为0分，定为E类公司。评价计分低于60分的证券公司，定为D类公司。
中国证监会每年根据行业发展情况，结合以前年度分类结果，事先确定A、B、C三大类别公司的相对比例，并根据评价计分的分布情况，具体确定各类别、各级别公司的数量，其中B类BB级及以上公司的评价计分应高于基准分100分。
（一）A类公司风险管理能力在行业内最高，能较好地控制新业务、新产品方面的风险；
（二）B类公司风险管理能力在行业内较高，在市场变化中能较好地控制业务扩张的风险；
（三）C类公司风险管理能力与其现有业务相匹配；
（四）D类公司风险管理能力低，潜在风险可能超过公司可承受范围；
（五）E类公司潜在风险已经变为现实风险，已被采取风险处置措施。
第十八条 证券公司在评价期内存在挪用客户资产、违规委托理财、财务信息虚假或股东虚假出资、抽逃出资等违法违规行为的，将公司类别下调3个级别；情节严重的，将公司类别直接认定为D类。
第十九条 证券公司在自评时，若不如实标注存在问题，存在遗漏、隐瞒等情况，将在应扣分事项上加倍扣分；自评时存在隐瞒重大事项或者报送、提供的信息和资料有虚假记载、误导性陈述或重大遗漏的，将视情节轻重将公司类别下调1至3个级别。
证券公司未在规定日期之前上报自评结果的，将公司类别下调1个级别；未在确定分类结果期限之前上报自评结果的，将公司类别直接认定为D类。
第五章 组织实施
第二十条 证券公司分类每年进行一次，评价期为上一年度5月1日至本年度4月30日，涉及的财务数据、业务数据原则上以上一年度经审计报表及中国证券业协会公布的信息为准。
第二十一条 证券公司分类按照证券公司自评、派出机构初审、中国证监会复核的程序进行。
第二十二条 证券公司应当按照本规定的要求进行自评。证券公司应结合自身情况，对照评价指标与标准，如实反映存在的问题及被采取的监管措施，经公司主要负责人和合规负责人签署确认后，将自评结果上报公司住所地中国证监会派出机构。
第二十三条 中国证监会派出机构在证券公司自评的基础上，根据日常监管掌握的情况，对证券公司自评结果进行初审和评价计分，将初审结果上报中国证监会。
在初审过程中，中国证监会派出机构可以就有关问题进行核查，并与证券公司核对情况，确认事实。
第二十四条 中国证监会在派出机构初审的基础上进行复核并确定证券公司的类别，于每年7月15日之前将分类结果书面告知证券公司。
证券公司对其分类结果有异议的，在收到分类结果书面通知之日起1个月内可向中国证监会提出书面申述。中国证监会在收到申述后1个月内予以答复。
第二十五条 对于在自评时隐瞒事项或者报送、提供的信息和资料有虚假记载、误导性陈述或重大遗漏的证券公司，中国证监会派出机构应当对公司主要负责人视情节轻重采取监管谈话等措施，并记入诚信档案。
第二十六条 中国证监会派出机构在日常监管工作中，对证券公司发生的违规行为和异常情况应及时调查、迅速采取适当的监管措施并记入监管档案，在此基础上对证券公司进行客观、公正的初审和评价计分。中国证监会派出机构对证券公司的违法违规行为是否及时、充分采取相应监管措施，以及证券公司分类初审的质量，是落实辖区监管责任制，考评中国证监会派出机构证券公司监管工作绩效的重要依据。
第二十七条 证券公司状况发生重大变化或者出现异常且足以导致公司分类类别调整的，中国证监会及其派出机构应当根据有关情况及时对相关证券公司的分类进行动态调整；证券公司也可以向派出机构提出调整分类的申请，经派出机构初审后报中国证监会复核确定。
上述分类调整属于调高证券公司类别的，证券公司评价指标应当持续6个月以上满足与调高类别相应的标准。
第六章 分类结果使用
第二十八条 中国证监会按照分类监管原则，对不同类别证券公司规定不同的风险控制指标标准和风险资本准备计算比例，并在监管资源分配、现场检查和非现场检查频率等方面区别对待。
第二十九条 证券公司分类结果将作为证券公司申请增加业务种类、新设营业网点、发行上市等事项的审慎性条件。
第三十条 证券公司分类结果将作为确定新业务、新产品试点范围和推广顺序的依据。
第三十一条 中国证券投资者保护基金公司根据证券公司分类结果，确定不同级别的证券公司缴纳证券投资者保护基金的具体比例。
第三十二条 证券公司分类结果主要供中国证监会及其派出机构使用，证券公司不得将分类结果用于广告、宣传、营销等商业目的。
第七章 附则
第三十三条 证券公司控股的证券子公司，可以合并纳入母公司分类评价，母子公司合并评价的，母公司的分类结果适用于子公司。
第三十四条 本规定下列用语的含义：
（一）主要风险控制指标，是指净资本、净资本/各项风险资本准备之和、净资本/净资产、净资本/负债、净资产/负债等5项指标。
（二）成本管理能力，是指营业收入与营业支出的比例，用（营业收入－投资收益－公允价值变动收益）/营业支出进行衡量。
第三十五条 本规定自公布之日起施行。
附件：
证券公司风险管理能力评价指标与标准
评价指标 序号 评价标准
1、资本充足 1.01 净资本绝对数指标符合规定标准
1.02 净资本相对数指标符合规定标准
1.03 各项业务风控指标符合规定标准
2、公司治理与合规管理 2.01 股东会、董事会、监事会有效运作，公司股东资格及行为、公司董事、监事、高管人员资质及任免变更符合监管要求
2.02 内部组织架构和业务管控制度健全有效
2.03 内部激励约束机制和责任追究制度科学合理并有效执行
2.04 合规管理组织体系和保障措施健全有效
2.05 合规管理制度有效执行，合规考核纳入员工绩效考核、合规文化建设融入经营管理全过程
2.06 合规总监切实履行职责，并按要求及时向证券监管部门报告违法违规行为或合规风险隐患
3、动态风险监控 3.01 风控组织体系独立有效运作
3.02 风控指标动态监控系统及各项业务风险控制机制健全，能动态识别、度量、预警、报告及处理各类风险
3.03 压力测试及敏感性分析机制健全有效并能按要求报送分析测试报告
3.04 净资本补足机制和业务规模调整机制健全并能有效实施
4、信息系统安全 4.01 IT治理完善，信息系统管理机制独立有效
4.02 信息系统功能齐备，有效满足客户委托、交易、清算、开户、查询等需求，客户电子资料等信息安全
4.03 信息系统安全稳定运行，能够避免频繁信息安全事故或重大事故
4.04 信息系统应急预案有效， 能够及时应对信息安全事故
5、客户权益保护 5.01 客户资产存放管理制度完善，能够有效保障客户资产安全
5.02 客户服务和管理制度健全，能够了解客户并提供适当性产品和服务
5.03 营销人员管理制度健全，有效防止营销人员损害客户权益
5.04 客户投诉处理机制有效，能够稳妥处理各类上访、投诉、纠纷，防止群体性事件、恶性个案发生
5.05 投资者教育融入各项业务流程和服务环节，在防范和打击非法证券活动中积极发挥作用
6、信息披露 6.01 年度报告真实、准确、完整，不存在虚假记载、误导性陈述或重大遗漏，能按规定及时报告和披露
6.02 综合监管报表真实、准确、完整，不存在虚假记载、误导性陈述或重大遗漏，能按规定及时报告
6.03 公开披露的信息以及向股东和监管部门报告的信息真实、准确、完整、及时，不存在虚假记载、误导性陈述或重大遗漏
6.04 重要事项报告和处理机制健全，发生信息安全事故、群体性事件、恶性个案、被其他政府部门采取行政处罚措施、涉及刑事民事诉讼等重大事项能按规定及时向监管部门报告并及时处理，能及时应对涉及公司的舆论报道
6.05 按规定使用分类评价结果
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.