宁夏回族自治区保护消费者合法权益条例
宁夏回族自治区人大常务委员会
宁夏回族自治区保护消费者合法权益条例
宁夏回族自治区人大常务委员会
第一章 总 则
第一条 为了保护消费者的合法权益，加强对商品生产、销售和服务的监督，根据《中华人民共和国消费者权益保护法》和有关法律、法规的规定，结合自治区实际，制定本条例。
第二条 本条例所称消费者，是指为生活消费需要购买、使用商品或者接受服务的个人和单位。
本条例所称经营者，是指为消费者生产、销售商品或者提供服务的单位和个人。
第三条 县级以上人民政府应当履行保护消费者合法权益的职责，对于消费者权益保护工作的重大事项应当定期听取汇报，并组织、协调、督促有关行政部门做好保护消费者合法权益工作。
县级以上人民政府工商行政管理、质量技术监督、物价、卫生等有关部门应当在各自的职责范围内，加强对商品生产、销售和服务的监督检查，受理消费者的申诉，调查处理损害消费者合法权益的行为。
县级以上人民政府及其有关行政部门制定有关消费者权益的规范性文件时，应当通过新闻媒体公布，召开座谈会等形式听取消费者的意见和要求。
第四条 保护消费者的合法权益是全社会的共同责任。对损害消费者合法权益的行为，一切组织和个人有权进行监督。大众传播媒介应当做好维护消费者合法权益的宣传，对损害消费者合法权益的行为有权揭露、批评。
第二章 消费者的权利
第五条 消费者在购买、使用商品或者接受服务时，享有下列权利：
（一）自主选择商品和服务；
（二）了解商品和服务的真实情况；
（三）得到质量、计量、卫生、安全和合法价格的保障；
（四）要求提供购货凭证、服务单据和有关资料，得到必要的技术指导和售后服务；
（五）在规定或者约定的期限内出现故障或者影响正常使用的商品，要求修理、重作、更换、退货；
（六）合法权益受到损害时，要求赔偿，或者投诉、申诉、起诉、申请仲裁；
（七）人格尊严、民族风俗习惯受尊重；
（八）人身、财产安全受保障；
（九）对损害消费者合法权益的违法行为，进行检举、揭发、控告；
（十）有关法律、法规规定的其他权利。
第六条 消费者享有依法成立维护自身合法权益的社会团体的权利。
第三章 经营者的义务
第七条 经营者销售商品或者提供服务，应当依照有关法律、法规的规定履行义务。经营者和消费者有约定的，应当按照约定履行义务，但双方的约定不得违背法律、法规的规定。
第八条 经营者应当遵循平等、自愿、公平、诚实信用的原则，遵守下列规定：
（一）商品的质量、价格、计量、包装、标识、卫生和安全，应当符合法律、法规和有关规定；
（二）不得生产和销售假冒他人注册商标的商品；
（三）不得生产和销售违禁商品；
（四）不得伪造商品的产地、生产日期、许可证，伪造或者冒用他人的厂名、厂址、认证标志；
（五）不得销售应当检验、检疫而未检验、检疫或者伪造检验、检疫结果的商品；
（六）销售的商品和提供服务应当明码标价，不得以虚假的“清仓价”、“甩卖价”等欺骗性价格销售商品或者提供服务；
（七）不得拒绝消费者对商品质量、计量、价格的验证、复核；
（八）不得在销售的商品中掺杂、掺假，以次充好，以假充真，以旧充新，短尺少秤或者以不合格商品冒充合格商品；
（九）以预收货款、邮购、电视购物、网上购物、代办等方式销售商品或者提供服务的，应当保证质量，按期履约；
（十）不得强买、强卖、搭售商品、强行提供服务。提供选择性服务的，必须事先征得消费者的同意；
（十一）提供了解和选择商品的便利条件，需要启封、测试的商品应当无条件当面启封、测试，不得以商品的启封、测试为由强迫消费者购买；
（十二）不得以格式合同、通知声明、店堂告示等方式，做出对消费者不公平、不合理的规定，或者推御其损害消费者合法权益应当承担的民事责任；
（十三）不得拒绝、阻挠有关行政管理部门对商品、服务的监督检查和消费者协会对消费投诉的调查；
（十四）不得以虚假的“有奖销售”等宣传形式欺骗消费者；
（十五）尊重少数民族的消费习惯。
第九条 经营者从事经营活动应当悬挂营业执照。租赁他人柜台、场地或者厂商联营从事经营活动的，应当标明自身的真实名称和标记；展销会举办者、场地和柜台提供者应当监督参展者和场地、柜台使用者悬挂营业执照并标明真实名称和标记。
第十条 从事美容、美发的经营者，应当合理收费，不得价外加价，不得使用伪劣美容、美发用品。从事生活美容的经营者不得从事医疗美容服务。从事医疗美容的经营者应当确保消费者的健康和生命安全。
第十一条 从事旅游业的经营者，应当按照约定的时间和内容，为消费者办好有关旅游手续，不得擅自改变旅游线路、旅游时间、游览景点、食宿标准、交通工具、收费项目等约定条件；不得误导、强制消费者购买商品或者接受服务。
第十二条 从事加工、修理业的经营者，应当保证加工、修理项目质量，按期履约，不得有下列行为：
（一）偷换原材料或者零配件；
（二）虚列加工、修理项目；
（三）使用伪劣零配件；
（四）谎称更换零配件；
（五）擅自提高收费标准。
第十三条 销售商品房的经营者，应当以书面形式向消费者明示商品房的地址、结构、面积、价格、交房日期、配套设施、产权办理等内容，必须保证商品房达到国家规定的有关质量标准，不得将未经验收或者验收不合格的商品房交付使用。经营者不履行约定义务的，应当按照消费者
的要求予以换房或者退房。给消费者造成损失的，应当赔偿损失。
从事住宅装饰装修的经营者，应当与消费者以书面形式约定装饰装修的项目、数量、标准、价格、施工时限，并保证装饰装修的质量，不得偷工减料、价外加价。经营者不履行约定义务的，应当按照消费者的要求重作或者返工。给消费者造成损失的，应当赔偿损失。
第十四条 从事物业管理的经营者应当对受委托管理的房屋及其共用部位、共用设备、公共设施进行维护、修缮、更新，不得擅自扩大收费范围，提高收费标准。
第十五条 从事供电、供水、供热、供气的经营者，应当严格按照计量标准、价格收取费用，定期对设备进行检查维护，保证设备正常使用。不得限定消费者向其指定的经营者购买商品；不得擅自增加收费项目或者提高收费标准；不得强制消费者代收费用。
因计量不准或者不按规定标准而多收的费用，应当退还消费者。因所供电、水、热、气的质量不合格而造成消费者财产损失和人身损害的，应当赔偿消费者的损失。
第十六条 从事有线电视、邮政、电信业、医药的经营者，应当按照核定的项目、标准、价格收费，详列计价单位的明细项目并以清单的形式告知消费者，不得擅自增加收费项目或者提高收费标准；不得虚列收费项目或者重复收费；不得无故中止服务；不得拒绝消费者了解、查询消费
资料情况；不得收取查询费用。经营者不按规定的计量标准多收的费用，应当退还消费者。造成损失的，应当赔偿消费者的损失。
第十七条 从事医疗、卫生服务的，应当按照规定收取医疗费用，详列计价单位的明细项目并以清单的形式告知消费者，不得虚列收费项目或者重复收费；不得无故中止服务；不得涂改原始记录；不得拒绝患者查询检验、检查报告单等资料。
因使用不合格药品、不合格医疗器械或者违反诊疗护理规程，造成人身伤害的，应当依法承担民事责任。
第十八条 经营者销售商品或者提供服务，应当按照国家的有关规定或者商业惯例，向消费者出具购货凭证或者服务单据。消费者索要购货凭证或者服务单据、凭证的，经营者必须出具。
第十九条 经营者应当制定并公布维护消费者合法权益的制度，对从业人员进行维护消费者合法权益的教育，建立处理消费纠纷的责任制，及时、妥善处理消费纠纷。
第二十条 经营者按照国家规定或者向消费者的承诺，承担包修、包换、包退或者其他责任的，应当按照国家规定或者承诺履行，不得故意拖延或者无理拒绝。
第二十一条 经营者销售商品或者提供服务质量不符合规定或者约定的，应当在下列期限内予以修理、更换、退货或者重作，不得违反规定收取费用：
（一）法律、法规有期限规定的，按规定执行；
（二）经营者与消费者有约定的，约定期限不得少于3个月；
（三）法律、法规没有规定期限，经营者与消费者也没有约定的，期限不得少于6个月。
第二十二条 实行包修的商品，必须有保修点，在保修期内没有履行保修义务或者保修点已经撤销的，商品的销售者应当按照消费者的要求负责修理、更换、退货。包修商品需要运输和邮寄的，经营者应当承担往返运输费或者邮寄费用。
第四章 消费者组织
第二十三条 消费者协会和其他消费者组织是代表消费者对经营者销售商品和提供服务实行社会监督，保护消费者合法权益的社会团体。
县级以上行政区域应当设立消费者协会。消费者协会可在乡（镇）设立分支机构，或者在集贸市场、商业集中区等建立监督站，方便消费者咨询和投诉。消费者协会基层组织可以发展会员。
第二十四条 消费者协会履行下列职责：
（一）宣传、贯彻保护消费者权益的法律、法规；
（二）受理消费者投诉，对投诉事项依法进行调查、调解；
（三）参与有关部门对商品和服务的质量、价格、卫生、安全、计量等进行检查和测定；
（四）协同有关部门查处假冒、伪劣商品；
（五）对损害消费者合法权益的行为进行批评、揭露，并通过舆论工具向社会公布或者向有关行政管理部门提出处理建议；
（六）参与拟定保护消费者合法权益的法规、规章及规范性文件；
（七）为消费者提供消费信息和咨询服务。引导消费者科学、合理的消费；
（八）对维护消费者合法权益表现突出的单位和个人，予以表彰和奖励；
（九）法律、法规规定的其他职责。
第二十五条 县级以上人民政府及有关部门应当支持消费者协会和其他消费者组织开展工作。为消费者协会提供必要的经费和工作条件，保障其职责的正常履行。
对消费者协会提出的查询，有关部门应当在15日内作出答复；拒不答复的，消费者协会可向有关部门的本级人民政府或者上级机关报告，也可向社会披露。
第二十六条 消费者组织不得从事商品经营和营利性服务，不得以营利为目的向社会推荐商品和服务。
第五章 争议的解决
第二十七条 消费者与经营者发生消费权益纠纷的，可协商解决。协商无效的，可选择下列方式请求保护：
（一）向消费者协会投诉；
（二）向有关行政部门申诉；
（三）向仲裁机构申请仲裁；
（四）向人民法院起诉。
第二十八条 消费者和经营者对商品质量或者服务质量有争议的，可以由双方约定的鉴定部门鉴定，也可以由受理申诉的行政部门或者受理投诉的消费者组织指定的法定部门鉴定。因鉴定发生的直接费用，由责任方承担。
第二十九条 消费者要求解决消费争议，应当提供购买商品或者接受服务的实物、购货凭证、服务单据或者有关证据。
对于难以检测、鉴定的，经营者应当提供证明自己无过错的证据，不能提供无过错证据的，应当承担责任。
第三十条 消费者组织应当自收到消费者投诉之日起5日内作出是否受理的决定。不予受理的，应当向消费者说明理由；决定受理的一般投诉，应当在30日内作出处理；决定受理的重大复杂投诉，应当在60日内作出处理。
有关行政部门对消费者的申诉或者消费者组织提请处理的纠纷，应当自接到申诉书或者消费者组织的建议书之日起5日内，作出是否受理的决定。决定不受理的，应当向消费者或者消费者组织说明理由。决定受理的，应当在60日内作出处理。
法律、法规有规定的，从其规定。
第六章 法律责任
第三十一条 经营者销售商品或者提供服务，造成消费者或者他人人身伤害、残疾或者死亡的，按照下列规定标准支付费用：
（一）医疗费，按医院对受害者治疗所必需的费用计算；
（二）治疗期间护理费，受害者治疗期间生活不能自理的，按照当地雇请一名护理人员所需费用计算；
（三）治疗期间的交通费，按照与受害人的身体状况相适应所必需的交通费用计算；
（四）误工费，按照受害者因误工减少的实际收入计算，实际收入难以确认的，按照职工年平均工资标准和实际误工天数（包括节假日）计算；
（五）残疾者生活自助器具费，按照普及型器具的费用计算；
（六）残疾者一次性生活补助，受害者丧失部分或者全部劳动能力的，按照年平均生活费的5倍至30倍计算；
（七）残疾赔偿金，根据受害者伤残等级或者程度，按照职工年平均工资的10倍至20倍计算；
（八）丧葬费，按照当地殡葬单位基本服务项目收费标准计算；
（九）死亡赔偿金，按职工年平均工资的20倍计算；
（十）丧失劳动能力的残疾者或者死者生前被抚养人的生活费，以平均生活费为标准，对不满18周岁的，按抚养到18周岁计算；对其他无劳动能力的，按抚养20年计算。
前款所称职工年平均工资，是指自治区人民政府统计部门公布的上一年度当地职工平均工资。前款所称年平均生活费，是指自治区人民政府统计部门公布的上一年度城镇居民家庭或者农民家庭人均生活费的支出额。
法律、法规对本条规定的支付费用另有规定的，从其规定。
第三十二条 经营者在承担商品修理、更换、退货或者重作责任期内，因拖延时间给消费者造成直接经济损失的，应当给予赔偿。
第三十三条 经营者销售商品或者提供服务有下列欺诈行为的，应当按照消费者的要求增加赔偿其受到的损失，增加赔偿的金额为消费者购买商品的价格或者接受服务费用的一倍：
（一）进行虚假宣传，发布虚假广告，现场虚假演示和说明，雇佣他人进行欺骗性销售诱导，以及对消费者的承诺不予履行的；
（二）以虚假的“清仓价”、“甩卖价”等欺骗性价格表示的；
（三）销售“处理品”等商品不予标明的；
（四）以虚假的“有奖销售”等方式销售商品的；
（五）销售掺杂、掺假、以假充真、以次充好、以不合格商品冒充合格商品的，或者销售过期、失效、变质、受污染的商品的；
（六）伪造商品的产地、生产日期或者许可证、检验证、检疫证的，伪造冒用他人的厂名、厂址、认证标志的；
（七）不以自己的真实名称或者标记从事经营活动的；
（八）采取虚假的计量或者其他不正当手段，变相提高价格的；
（九）偷换原材料、零配件，虚列加工、修理项目，使用伪劣零配件或者谎称更换零配件的；
（十）以邮购、网上购物、中介服务等方式骗取价款或者酬金不提供或者不按照约定条件提供商品或者服务的；
（十一）有其他欺诈行为的。
法律、法规另有规定的，从其规定。
第三十四条 经营者违反本条例，损害消费者权益，法律、法规已有处罚规定的，从其规定；法律、法规没有规定的，由工商行政管理部门或者有关行政机关责令改正，根据情节单处或者并处警告、没收违法所得、处以违法所得一倍以上五倍以下的罚款；没有违法所得的，处以五千元
以上一万元以下的罚款；情节严重的，责令停业整顿、暂扣营业执照；构成犯罪的，由司法机关依法追究刑事责任。
第三十五条 因销售商品质量或者提供服务质量不合格使消费者合法权益受到损害的，销售者或者服务者应当接受消费者的要求给予赔偿。销售者赔偿后，属于生产者的责任或者供货者的责任，销售者有权向生产者或者供货者追偿。
第三十六条 经营者侮辱、诽谤消费者，搜查消费者的身体及其携带物品，侵害消费者的人格尊严或者侵犯消费者人身自由的，应当停止侵害、恢复名誉、消除影响、赔礼道歉，后果严重的，给予精神赔偿；构成犯罪的，由司法机关依法追究刑事责任。
第三十七条 当事人对行政处罚决定不服的，可依法申请行政复议或者提起行政诉讼。当事人逾期不申请复议、也不起诉、又不履行处罚决定的，由作出处罚决定的机关申请人民法院强制执行。
第三十八条 以暴力、威胁等方式阻碍行政部门工作人员或者消费者组织工作人员依法履行职责的，由公安机关依照《中华人民共和国治安管理处罚条例》的规定予以处罚；构成犯罪的，依法追究刑事责任。
第三十九条 有关行政部门、消费者协会及其工作人员不依法履行职责，玩忽职守，滥用职权，徇私舞弊的，由其所在单位或者上级主管部门给予行政处分；给当事人造成损失的，依法承担赔偿责任；构成犯罪的，由司法机关依法追究刑事责任。
第七章 附 则
第四十条 购买、使用直接用于农业、畜牧业、渔业、林业生产的生产资料或者接受相关服务，其合法权益受到损害的，法律、法规有规定的，从其规定；法律、法规没有规定的，参照本条例执行。
第四十一条 本条例自2001年1月1日起施行。1991年12月28日宁夏回族自治区第六届人民代表大会常务委员会第二十二次会议通过的《宁夏回族自治区保护消费者合法权益条例》同时废止。
2000年11月17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.
