| Order of the State Administration for Market Regulation | | 国家市场监督管理总局令 |
| (No. 27) | | （第27号） |
| The Measures for the Administration of Drug Registration, as deliberated and adopted at the 1st executive meeting of 2020 of the State Administration for Market Regulation on January 15, 2020, are hereby issued and shall come into force on July 1, 2020. | | 《药品注册管理办法》已于2020年1月15日经国家市场监督管理总局2020年第1次局务会议审议通过，现予公布，自2020年7月1日起施行。 |
| Director: Xiao Yaqing | | 局长 肖亚庆 |
| January 22, 2020 | | 2020年1月22日 |
| Measures for the Administration of Drug Registration | | 药品注册管理办法 |
| (Issued by Order No. 27 of the State Administration for Market Regulation, January 22, 2020) | | （2020年1月22日国家市场监督管理总局令第27号公布） |
| Chapter I General Provisions | | 第一章 总 则 |
| Article 1 For the purposes of regulating the drug registration behavior, and ensuring the safety, effectiveness, and controllable quality of drugs, these Measures are developed according to the Medicinal Product Administration Law of the People's Republic of China (hereinafter referred to as the “Medicinal Product Administration Law”), the Law of the People's Republic of China on Traditional Chinese Medicine, the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the “Vaccine Administration Law”), the Administrative Licensing Law of the People's Republic of China, the Regulations for the Implementation of the Medicinal Product Administration Law of the People's Republic of China, and other laws and administrative regulations. | | 第一条 为规范药品注册行为，保证药品的安全、有效和质量可控，根据《中华人民共和国药品管理法》（以下简称《药品管理法》）、《中华人民共和国中医药法》、《中华人民共和国疫苗管理法》（以下简称《疫苗管理法》）、《中华人民共和国行政许可法》、《中华人民共和国药品管理法实施条例》等法律、行政法规，制定本办法。 |
| Article 2 These Measures shall be applicable to the drug development, registration, supervision and management activities carried out in the territory of the People's Republic of China for marketing of drugs. | | 第二条 在中华人民共和国境内以药品上市为目的，从事药品研制、注册及监督管理活动，适用本办法。 |
| Article 3 “Drug registration” means the activities that a drug registration applicant (hereinafter referred to as an “applicant”) files an application and other supplementary applications for clinical drug trial, approval for drug marketing, and re-registration, among others, under the legal procedures and according to the relevant requirements, and that the medical products administrative department examines the safety, effectiveness, and quality controllability based on the laws and regulations, and the existing scientific cognitions, to decide whether to agree with the activities applied for. | | 第三条 药品注册是指药品注册申请人（以下简称申请人）依照法定程序和相关要求提出药物临床试验、药品上市许可、再注册等申请以及补充申请，药品监督管理部门基于法律法规和现有科学认知进行安全性、有效性和质量可控性等审查，决定是否同意其申请的活动。 |
| After obtaining a drug registration certificate, an applicant shall be the drug marketing authorization holder (hereinafter referred to as “holder”). | | 申请人取得药品注册证书后，为药品上市许可持有人（以下简称持有人）。 |
| Article 4 The drug registration shall be subject to classified registration administration by traditional Chinese drug, chemical drug, and biological products. | | 第四条 药品注册按照中药、化学药和生物制品等进行分类注册管理。 |
| The registration of traditional Chinese drugs shall be classified by innovative traditional Chinese drugs, new modified traditional Chinese drugs, compound preparations of ancient classic famous Chinese traditional drugs, and drugs of the same name and prescription, among others. | | 中药注册按照中药创新药、中药改良型新药、古代经典名方中药复方制剂、同名同方药等进行分类。 |
| The registration of chemical drugs shall be classified by innovative chemical drugs, new modified chemical drugs, and generic drugs, among others. | | 化学药注册按照化学药创新药、化学药改良型新药、仿制药等进行分类。 |
| The registration of biological products shall be classified by innovative drugs of biological products, new modified drugs of biological products, and biological products on the market (including biological similar drugs), among others. | | 生物制品注册按照生物制品创新药、生物制品改良型新药、已上市生物制品（含生物类似药）等进行分类。 |
| The requirements for the detailed classification of traditional Chinese drugs, chemical drugs, and biological products, and the corresponding application materials shall be developed by the National Medical Products Administration (“NMPA”) according to the product characteristics, innovation degree, and evaluation management needs of registered drugs, and be announced to the public. | | 中药、化学药和生物制品等药品的细化分类和相应的申报资料要求，由国家药品监督管理局根据注册药品的产品特性、创新程度和审评管理需要组织制定，并向社会公布。 |
| The application for registration of drugs produced overseas shall be filed in accordance with the requirements for the detailed classification and the corresponding application materials. | | 境外生产药品的注册申请，按照药品的细化分类和相应的申报资料要求执行。 |
| Article 5 NMPA shall be in charge of the drug registration management across the country, and be responsible for establishing the work system and rules for the management of drug registration, developing the management standards for drug registration, and organizing the evaluation of and approval for drug registration, and the relevant supervision and administration work according to the law. The Center for Drug Evaluation of NMPA (hereinafter referred to as the “Center for Drug Evaluation”) shall be responsible for the evaluation of applications for clinical drug trial, applications for drug marketing authorization, supplementary applications, and applications for re-registration of drugs produced overseas. The National Institutes for Food and Drug Control (“NIFDC”), the Chinese Pharmacopoeia Commission (“CHP”), the Center for Food and Drug Inspection of NMPA (hereinafter referred to as the “Center for Inspection”), the Center for Drug Reevaluation of NMPA (hereinafter referred to as the “Center for Drug Reevaluation”), the Center for Administrative Services and Complaints & Reports of NMPA, the Information Center of NMPA (hereinafter referred to as the “Information Center”), and other professional technical institutions of drugs shall undertake drug registration examination, confirmation of common name, inspection, monitoring, and reevaluation, certificate making and delivery, corresponding information construction and management, and other relevant work required for the administration of drug registration according to the law. | | 第五条 国家药品监督管理局主管全国药品注册管理工作，负责建立药品注册管理工作体系和制度，制定药品注册管理规范，依法组织药品注册审评审批以及相关的监督管理工作。国家药品监督管理局药品审评中心（以下简称药品审评中心）负责药物临床试验申请、药品上市许可申请、补充申请和境外生产药品再注册申请等的审评。中国食品药品检定研究院（以下简称中检院）、国家药典委员会（以下简称药典委）、国家药品监督管理局食品药品审核查验中心（以下简称药品核查中心）、国家药品监督管理局药品评价中心（以下简称药品评价中心）、国家药品监督管理局行政事项受理服务和投诉举报中心、国家药品监督管理局信息中心（以下简称信息中心）等药品专业技术机构，承担依法实施药品注册管理所需的药品注册检验、通用名称核准、核查、监测与评价、制证送达以及相应的信息化建设与管理等相关工作。 |
| Article 6 The medical products administrative department of a province, autonomous region, or municipality directly under the Central Government shall be responsible for the administration concerning the following drug registration within its respective administrative region: | | 第六条 省、自治区、直辖市药品监督管理部门负责本行政区域内以下药品注册相关管理工作： |
| (1) Acceptance, examination and approval of an application for re-registration of a domestically produced drug. | | （一）境内生产药品再注册申请的受理、审查和审批； |
| (2) Administration of the recordation for change in a drug after marketing and the reporting matters. | | （二）药品上市后变更的备案、报告事项管理； |
| (3) Organizing the investigation into and handling of the routine supervision and administration, and illegal acts of the institution for non-clinical drug safety reevaluation research and the institution for clinical drug trial. | | （三）组织对药物非临床安全性评价研究机构、药物临床试验机构的日常监管及违法行为的查处； |
| (4) Participating in the inspection, examination, and other work of drug registration organized by NMPA. | | （四）参与国家药品监督管理局组织的药品注册核查、检验等工作； |
| (5) Matters concerning drug registration entrusted by NMPA. | | （五）国家药品监督管理局委托实施的药品注册相关事项。 |
| The professional technical institutions of drugs established or designated by the medical products administrative department of a province, autonomous region, or municipality directly under the Central Government shall assume the evaluation, examination, inspection, monitoring, reevaluation and other work required for the supervision and administration of drugs according to the law. | | 省、自治区、直辖市药品监督管理部门设置或者指定的药品专业技术机构，承担依法实施药品监督管理所需的审评、检验、核查、监测与评价等工作。 |
| Article 7 The administration of drug registration shall follow the principles of openness, fairness and impartiality, be guided by clinical value, encourage research and development of new drugs, and actively promote the development of generic drugs. | | 第七条 药品注册管理遵循公开、公平、公正原则，以临床价值为导向，鼓励研究和创制新药，积极推动仿制药发展。 |
| NMPA shall continuously improve the reform of the evaluation and approval system, optimize the evaluation and approval procedures, improve the evaluation and approval efficiency, and establish a drug registration management system that is led by evaluation and supported by inspection, examination, monitoring and reevaluation. | | 国家药品监督管理局持续推进审评审批制度改革，优化审评审批程序，提高审评审批效率，建立以审评为主导，检验、核查、监测与评价等为支撑的药品注册管理体系。 |
| Chapter II Basic System and Requirements | | 第二章 基本制度和要求 |
| Article 8 The drug development and drug registration activities shall be carried out in compliance with the relevant laws, regulations, rules, standards and specifications; where other reevaluation methods and technologies are adopted with reference to the relevant technical guidance, its scientificity and applicability shall be proved; and the information during the whole process shall be guaranteed to be authentic, accurate, complete and traceable. | | 第八条 从事药物研制和药品注册活动，应当遵守有关法律、法规、规章、标准和规范；参照相关技术指导原则，采用其他评价方法和技术的，应当证明其科学性、适用性；应当保证全过程信息真实、准确、完整和可追溯。 |
| A drug shall meet the national drug standards and the drug quality standards approved by NMPA. The drug quality standards approved by NMPA shall be the drug registration standards. The drug registration standards shall satisfy the general technical requirements of the Pharmacopoeia of the People's Republic of China and shall not be lower than the provisions of the Pharmacopoeia of the People's Republic of China. Where the Pharmacopoeia of the People's Republic of China does not apply to the testing items or indicators of a variety for which an application for registration is filed, the applicant shall provide sufficient supporting data. | | 药品应当符合国家药品标准和经国家药品监督管理局核准的药品质量标准。经国家药品监督管理局核准的药品质量标准，为药品注册标准。药品注册标准应当符合《中华人民共和国药典》通用技术要求，不得低于《中华人民共和国药典》的规定。申报注册品种的检测项目或者指标不适用《中华人民共和国药典》的，申请人应当提供充分的支持性数据。 |
| The Center for Drug Evaluation and other professional technical institutions shall develop technical guiding principles and procedures according to the scientific progress, actual circumstance of industry development, and needs of drug supervision and administration, and announce them to the public. | | 药品审评中心等专业技术机构，应当根据科学进展、行业发展实际和药品监督管理工作需要制定技术指导原则和程序，并向社会公布。 |
| Article 9 An applicant shall be an enterprise or drug development institution that can assume corresponding legal responsibilities. A foreign applicant shall designate an enterprise legal person in the territory of China to handle relevant drug registration matters. | | 第九条 申请人应当为能够承担相应法律责任的企业或者药品研制机构等。境外申请人应当指定中国境内的企业法人办理相关药品注册事项。 |
| Article 10 An applicant shall, before applying for marketing registration of a drug, complete pharmaceutical research, pharmacological and toxicological research, clinical drug trial, and other relevant research work. Non-clinical safety reevaluation research of a drug shall be carried out by an institution with certification of the Good Laboratory Practice for Non-Clinical Laboratory Studies (GLP), and comply with the GLP. Clinical drug trial shall be approved, of which recordation shall be conducted for the bioequivalence test; and clinical drug trial shall be carried out at an institution for clinical drug trial in compliance with the relevant provisions and comply with the Good Clinical Practice (GCP). | | 第十条 申请人在申请药品上市注册前，应当完成药学、药理毒理学和药物临床试验等相关研究工作。药物非临床安全性评价研究应当在经过药物非临床研究质量管理规范认证的机构开展，并遵守药物非临床研究质量管理规范。药物临床试验应当经批准，其中生物等效性试验应当备案；药物临床试验应当在符合相关规定的药物临床试验机构开展，并遵守药物临床试验质量管理规范。 |
| To apply for drug registration, an applicant shall provide authentic, sufficient and reliable data, materials and samples to prove the safety, effectiveness and quality controllability of the drug. | | 申请药品注册，应当提供真实、充分、可靠的数据、资料和样品，证明药品的安全性、有效性和质量可控性。 |
| Where overseas research materials and data are used to support drug registration, their source, research institution or laboratory conditions, quality system requirements, and other management conditions shall follow the prevailing principles of the International Conference on Harmonization (“ICH”) and satisfy the relevant requirements of China for the administration of drug registration. | | 使用境外研究资料和数据支持药品注册的，其来源、研究机构或者实验室条件、质量体系要求及其他管理条件等应当符合国际人用药品注册技术要求协调会通行原则，并符合我国药品注册管理的相关要求。 |
| Article 11 To change the items or contents specified in the original drug registration approval document and its annexes, an applicant shall, according to the provisions and with reference to the relevant technical guiding principles, sufficiently study and verify the change in a drug, fully assess the impact of the possibility of change on the safety, effectiveness and quality controllability of the drug, and file a supplementary application, undergo recordation or report it under the change procedure. | | 第十一条 变更原药品注册批准证明文件及其附件所载明的事项或者内容的，申请人应当按照规定，参照相关技术指导原则，对药品变更进行充分研究和验证，充分评估变更可能对药品安全性、有效性和质量可控性的影响，按照变更程序提出补充申请、备案或者报告。 |
| Article 12 A drug registration certificate shall be valid for five years. During the validity period, a holder of a drug registration certificate shall continue to ensure the safety, effectiveness and quality controllability of the marketed drug, and apply for re-registration of the drug six months prior to the expiry of the validity period. | | 第十二条 药品注册证书有效期为五年，药品注册证书有效期内持有人应当持续保证上市药品的安全性、有效性和质量可控性，并在有效期届满前六个月申请药品再注册。 |
| Article 13 NMPA shall establish an accelerated drug registration system to support clinical value-oriented drug innovation. For a qualified application for drug registration, an applicant may apply for applying a breakthrough therapeutic drug, conditional approval, preferential evaluation and approval, and special approval procedures. During the process of drug development and registration, the medical products administrative department and its professional technical institution shall offer necessary technical guidance, communication and exchange, priority allocation of resources, shortened evaluation time limit, and other policy and technical support. | | 第十三条 国家药品监督管理局建立药品加快上市注册制度，支持以临床价值为导向的药物创新。对符合条件的药品注册申请，申请人可以申请适用突破性治疗药物、附条件批准、优先审评审批及特别审批程序。在药品研制和注册过程中，药品监督管理部门及其专业技术机构给予必要的技术指导、沟通交流、优先配置资源、缩短审评时限等政策和技术支持。 |
| Article 14 NMPA shall establish a system for related evaluation and approval of chemical active pharmaceutical ingredients (“APIs”), auxiliary materials, and packaging materials and containers in direct contact with drugs. In the approval of drug preparations, chemical APIs shall be jointly evaluated and approved, and the relevant auxiliary materials and packaging materials and containers in direct contact with drugs shall be jointly evaluated. The Center for Drug Evaluation shall establish an information registration platform for chemical APIs, auxiliary materials, and packaging materials and containers in direct contact with drugs, announce the relevant registration information for selection by relevant applicants or holders, and conduct related evaluation when evaluating the relevant applications for registration of drug preparations. | | 第十四条 国家药品监督管理局建立化学原料药、辅料及直接接触药品的包装材料和容器关联审评审批制度。在审批药品制剂时，对化学原料药一并审评审批，对相关辅料、直接接触药品的包装材料和容器一并审评。药品审评中心建立化学原料药、辅料及直接接触药品的包装材料和容器信息登记平台，对相关登记信息进行公示，供相关申请人或者持有人选择，并在相关药品制剂注册申请审评时关联审评。 |
| Article 15 Prescription drugs and over-the-counter (OTC) drugs shall be subject to classified registration and conversion management. The Center for Drug Evaluation shall, according to the characteristics of OTC drugs, develop relevant technical guiding principles and procedures for the marketing registration of OTC drugs and announce them to the public. The Center for Drug Reevaluation shall develop relevant technical requirements and procedures for the conversion of prescription and OTC drugs after marketing, and announce them to the public. | | 第十五条 处方药和非处方药实行分类注册和转换管理。药品审评中心根据非处方药的特点，制定非处方药上市注册相关技术指导原则和程序，并向社会公布。药品评价中心制定处方药和非处方药上市后转换相关技术要求和程序，并向社会公布。 |
| Article 16 An applicant may, before applying for clinical drug trial, during the process of clinical drug trial, before applying for marketing license of a drug, and at other key stages, conduct communication and exchange on major problems with the Center for Drug Evaluation and other professional technical institutions. During the drug registration process, the Center for Drug Evaluation and other professional technical institutions may, as needed for work, organize communication and exchange with applicants. | | 第十六条 申请人在药物临床试验申请前、药物临床试验过程中以及药品上市许可申请前等关键阶段，可以就重大问题与药品审评中心等专业技术机构进行沟通交流。药品注册过程中，药品审评中心等专业技术机构可以根据工作需要组织与申请人进行沟通交流。 |
| The procedures, requirements and time limit for communication and exchange shall be separately developed by the Center for Drug Evaluation and other professional technical institutions according to their functions and be announced to the public. | | 沟通交流的程序、要求和时限，由药品审评中心等专业技术机构依照职能分别制定，并向社会公布。 |
| Article 17 The Center for Drug Evaluation and other professional technical institutions shall, as needed for work, establish an expert consultation system, form an expert consultation committee, request experts' opinions on major issues during the process of evaluation, inspection, examination, and confirmation of common name, and fully maximize the technical supporting role of experts. | | 第十七条 药品审评中心等专业技术机构根据工作需要建立专家咨询制度，成立专家咨询委员会，在审评、核查、检验、通用名称核准等过程中就重大问题听取专家意见，充分发挥专家的技术支撑作用。 |
| Article 18 NMPA shall establish and record catalogue sets of chemical drugs that are newly approved to be marketed and that pass the consistency reevaluation of the quality and efficacy of generic drugs, specify the drug name, active ingredients, dosage form, specifications, whether it is a reference preparation, holder and other relevant information, update them in a timely manner, and announce them to the public. The procedures and requirements for the recording of the catalogue sets of chemical drugs shall be developed by the Center for Drug Evaluation and be announced to the public. | | 第十八条 国家药品监督管理局建立收载新批准上市以及通过仿制药质量和疗效一致性评价的化学药品目录集，载明药品名称、活性成分、剂型、规格、是否为参比制剂、持有人等相关信息，及时更新并向社会公开。化学药品目录集收载程序和要求，由药品审评中心制定，并向社会公布。 |
| Article 19 NMPA shall support the inheritance and innovation of traditional Chinese medicine, establish and improve a registration management system and technical reevaluation system that meets the characteristics of traditional Chinese medicine, encourage the use of modern science and technology and traditional research methods to develop traditional Chinese medicine, strengthen the quality control of traditional Chinese medicine, and improve the clinical trial level of traditional Chinese medicine. | | 第十九条 国家药品监督管理局支持中药传承和创新，建立和完善符合中药特点的注册管理制度和技术评价体系，鼓励运用现代科学技术和传统研究方法研制中药，加强中药质量控制，提高中药临床试验水平。 |
| For an application for registration of traditional Chinese medicine, an applicant shall assess the clinical value and resource, highlight the clinical value as a guidance, and promote the sustainable use of resources. | | 中药注册申请，申请人应当进行临床价值和资源评估，突出以临床价值为导向，促进资源可持续利用。 |
| Chapter III Marketing Registration of Drugs | | 第三章 药品上市注册 |
| Section 1 Clinical drug trial | | 第一节 药物临床试验 |
| Article 20 For the purpose of these Measures, clinical drug trial means the drug research carried out in human body to determine the safety and effectiveness of a drug for the purposes of marketing registration of a drug. | | 第二十条 本办法所称药物临床试验是指以药品上市注册为目的，为确定药物安全性与有效性在人体开展的药物研究。 |
| Article 21 Clinical drug trial shall be divided into phase I clinical trial, phase II clinical trial, phase III clinical trial, phase IV clinical trial, and bioequivalence trial. According to the characteristics of a drug and the research purpose, the research contents shall include clinical pharmacological research, exploratory clinical trial, confirmatory clinical trial and post-marketing research. | | 第二十一条 药物临床试验分为Ⅰ期临床试验、Ⅱ期临床试验、Ⅲ期临床试验、Ⅳ期临床试验以及生物等效性试验。根据药物特点和研究目的，研究内容包括临床药理学研究、探索性临床试验、确证性临床试验和上市后研究。 |
| Article 22 Clinical drug trial shall be carried out in institutions for clinical drug trial that have corresponding conditions and that have undergone recordation formalities as required. Clinical trials of vaccines shall be implemented or organized by Grade 3 medical institutions or disease prevention and control institutions at or above the provincial level that meet the conditions prescribed by NMPA and the National Health Commission. | | 第二十二条 药物临床试验应当在具备相应条件并按规定备案的药物临床试验机构开展。其中，疫苗临床试验应当由符合国家药品监督管理局和国家卫生健康委员会规定条件的三级医疗机构或者省级以上疾病预防控制机构实施或者组织实施。 |
| Article 23 An applicant filing an application for clinical drug trial after completing the pharmaceutical research, pharmacological and toxicological research, and other researches supporting clinical drug trial shall submit relevant research materials according to the requirements for the application materials. After the formal examination, an application whose application materials satisfy the requirements shall be accepted. The Center for Drug Evaluation shall organize pharmaceutical, medical and other technical personnel to evaluate the accepted applications for clinical drug trials. An application for clinical drug trial shall be approved or disapproved within 60 days from the date of acceptance, and the applicant shall be notified of the approval result through the website of the Center for Drug Evaluation; and where an applicant is not notified within the prescribed time limit, the application shall be deemed to have been approved and the applicant may carry out clinical drug trial according to the submitted plan. | | 第二十三条 申请人完成支持药物临床试验的药学、药理毒理学等研究后，提出药物临床试验申请的，应当按照申报资料要求提交相关研究资料。经形式审查，申报资料符合要求的，予以受理。药品审评中心应当组织药学、医学和其他技术人员对已受理的药物临床试验申请进行审评。对药物临床试验申请应当自受理之日起六十日内决定是否同意开展，并通过药品审评中心网站通知申请人审批结果；逾期未通知的，视为同意，申请人可以按照提交的方案开展药物临床试验。 |
| An applicant approved to carry out a clinical drug trial shall be a sponsor for clinical drug trial (hereinafter referred to as “sponsor”). | | 申请人获准开展药物临床试验的为药物临床试验申办者（以下简称申办者）。 |
| Article 24 An applicant intending to carry out a bioequivalence test shall, after undergoing the recordation formalities for bioequivalence test at the website of the Center for Drug Evaluation as required, carry out relevant research work according to the plan recorded. | | 第二十四条 申请人拟开展生物等效性试验的，应当按照要求在药品审评中心网站完成生物等效性试验备案后，按照备案的方案开展相关研究工作。 |
| Article 25 A clinical drug trial to be carried out shall be examined and approved by the ethics committee. | | 第二十五条 开展药物临床试验，应当经伦理委员会审查同意。 |
| The management of drugs used in a clinical drug trial shall satisfy the relevant requirements of the GCP. | | 药物临床试验用药品的管理应当符合药物临床试验质量管理规范的有关要求。 |
| Article 26 A sponsor approved to carry out clinical drug trial shall, before carrying out subsequent clinical drug trial by stages, develop corresponding plan for clinical drug trial, carry out clinical drug trial upon examination and with consent of the ethics committee, and submit corresponding plan for clinical drug trial and supporting materials on the website of the Center for Drug Evaluation. | | 第二十六条 获准开展药物临床试验的，申办者在开展后续分期药物临床试验前，应当制定相应的药物临床试验方案，经伦理委员会审查同意后开展，并在药品审评中心网站提交相应的药物临床试验方案和支持性资料。 |
| Article 27 Where indications (or functions) are intended to be added for a drug approved for clinical drug trial and the use of a drug in combination with other drugs is added, an applicant shall file a new application for clinical drug trial, and may only carry out new clinical drug trial with approval. | | 第二十七条 获准开展药物临床试验的药物拟增加适应症（或者功能主治）以及增加与其他药物联合用药的，申请人应当提出新的药物临床试验申请，经批准后方可开展新的药物临床试验。 |
| Where a clinical drug trial needs to be carried out for indications (or functions) of a drug approved to be marketed, a new application for clinical drug trial shall be filed. | | 获准上市的药品增加适应症（或者功能主治）需要开展药物临床试验的，应当提出新的药物临床试验申请。 |
| Article 28 A sponsor shall submit a safety update report during the research and development period on the website of the Center for Drug Evaluation on a regular basis. The safety update report during the research and development period shall be submitted once a year, and within two months in every full year after the clinical drug trial is approved. The Center for Drug Evaluation may require a sponsor to adjust the reporting period based on the examination situation. | | 第二十八条 申办者应当定期在药品审评中心网站提交研发期间安全性更新报告。研发期间安全性更新报告应当每年提交一次，于药物临床试验获准后每满一年后的两个月内提交。药品审评中心可以根据审查情况，要求申办者调整报告周期。 |
| For information on suspicious and unexpected severe adverse reactions and other potentially serious safety risks that occur during the period of clinical drug trial, a sponsor shall report to the Center for Drug Evaluation in a timely manner as required. Depending on the severity of the safety risk, a sponsor may be required to take measures such as adjusting the plan for clinical drug trial, informed consent, and researchers' manual to strengthen risk control, and may be required to suspend or terminate the clinical drug trial if necessary. | | 对于药物临床试验期间出现的可疑且非预期严重不良反应和其他潜在的严重安全性风险信息，申办者应当按照相关要求及时向药品审评中心报告。根据安全性风险严重程度，可以要求申办者采取调整药物临床试验方案、知情同意书、研究者手册等加强风险控制的措施，必要时可以要求申办者暂停或者终止药物临床试验。 |
| The specific requirements of the safety update report during the research and development period shall be developed and announced by the Center for Drug Evaluation. | | 研发期间安全性更新报告的具体要求由药品审评中心制定公布。 |
| Article 29 Where, during the period of clinical drug trial, there is a change in the plan for clinical drug trial, a non-clinical or pharmacological change, or new discovery, a sponsor shall, according to the provisions and with reference to the relevant technical guiding principles, sufficiently assess the impact on the safety of the trial subjects. | | 第二十九条 药物临床试验期间，发生药物临床试验方案变更、非临床或者药学的变化或者有新发现的，申办者应当按照规定，参照相关技术指导原则，充分评估对受试者安全的影响。 |
| A sponsor deeming that the safety of the trial subjects is not affected upon assessment may directly conduct trial and reporting in the safety update report during the research and development period. Where the safety risk of trial subjects may be increased, a supplementary application shall be filed. A supplementary application for clinical drug trial shall be approved or disapproved within 60 days from the date of acceptance, and the applicant shall be notified of the approval result through the website of the Center for Drug Evaluation; and where an applicant is not notified within the prescribed time limit, the application shall be deemed to have been approved. | | 申办者评估认为不影响受试者安全的，可以直接实施并在研发期间安全性更新报告中报告。可能增加受试者安全性风险的，应当提出补充申请。对补充申请应当自受理之日起六十日内决定是否同意，并通过药品审评中心网站通知申请人审批结果；逾期未通知的，视为同意。 |
| Where the sponsor is changed, the changed sponsor shall assume the relevant responsibilities and obligations for the clinical drug trial. | | 申办者发生变更的，由变更后的申办者承担药物临床试验的相关责任和义务。 |
| Article 30 During the period of clinical drug trial, upon discovery of a safety problem or other risks, a sponsor shall adjust the plan for clinical drug trial, suspend or terminate the clinical trial in a timely manner, and report to the Center for Drug Evaluation. | | 第三十条 药物临床试验期间，发现存在安全性问题或者其他风险的，申办者应当及时调整临床试验方案、暂停或者终止临床试验，并向药品审评中心报告。 |
| Under one of the following circumstances, a sponsor may be required to adjust the plan for clinical drug trial, and suspend or terminate the clinical drug trial: | | 有下列情形之一的，可以要求申办者调整药物临床试验方案、暂停或者终止药物临床试验： |
| (1) The ethics committee fails to perform its duties. | | （一）伦理委员会未履行职责的； |
| (2) The safety of the trial subjects cannot be adequately ensured. | | （二）不能有效保证受试者安全的； |
| (3) The sponsor fails to submit a safety update report during the research and development period as required. | | （三）申办者未按照要求提交研发期间安全性更新报告的； |
| (4) The sponsor fails to handle or report the suspicious and unexpected severe adverse reactions in a timely manner. | | （四）申办者未及时处置并报告可疑且非预期严重不良反应的； |
| (5) There is evidence to prove that the research on drug is invalid. | | （五）有证据证明研究药物无效的； |
| (6) There is quality problem in the drug used for clinical trial. | | （六）临床试验用药品出现质量问题的； |
| (7) It practices fraud during the clinical drug trial. | | （七）药物临床试验过程中弄虚作假的； |
| (8) Other circumstances that violate the GCP. | | （八）其他违反药物临床试验质量管理规范的情形。 |
| When there is large-scale unexpected severe adverse reaction in a clinical drug trial, or there is evidence to prove that there is a serious quality problem in the drug used in the clinical trial, the sponsor and the institution for clinical drug trial shall immediately stop the clinical drug trial. The medical products administrative department may, according to the duties and functions, order the adjustment of plans for clinical trial, and suspension or termination of clinical drug trial. | | 药物临床试验中出现大范围、非预期的严重不良反应，或者有证据证明临床试验用药品存在严重质量问题时，申办者和药物临床试验机构应当立即停止药物临床试验。药品监督管理部门依职责可以责令调整临床试验方案、暂停或者终止药物临床试验。 |
| Article 31 After a clinical drug trial is ordered to be suspended, the sponsor intending to proceed with the clinical drug trial shall file a supplementary application for resuming the clinical drug trial after making rectification, and may only proceed with the clinical drug trial upon examination and with approval. Where the clinical drug trial has been suspended for three years, an application has not been filed, and clinical drug trial has not been approved to be resumed, the license of clinical drug trial shall automatically become invalid. | | 第三十一条 药物临床试验被责令暂停后，申办者拟继续开展药物临床试验的，应当在完成整改后提出恢复药物临床试验的补充申请，经审查同意后方可继续开展药物临床试验。药物临床试验暂停时间满三年且未申请并获准恢复药物临床试验的，该药物临床试验许可自行失效。 |
| Where, after the clinical drug trial is terminated, the clinical drug trial intends to be continued, an application for clinical drug trial shall be re-filed. | | 药物临床试验终止后，拟继续开展药物临床试验的，应当重新提出药物临床试验申请。 |
| Article 32 A clinical drug trial shall be implemented within three years after approval. Where, from the date when an application for clinical drug trial is approved, no trial subject signs an informed consent within three years, the license for clinical drug trial shall automatically become invalid. Where clinical drug trial still needs to be carried out, an application shall be re-filed. | | 第三十二条 药物临床试验应当在批准后三年内实施。药物临床试验申请自获准之日起，三年内未有受试者签署知情同意书的，该药物临床试验许可自行失效。仍需实施药物临床试验的，应当重新申请。 |
| Article 33 A sponsor shall, before carrying out clinical drug trial, register the plan for clinical drug trial and other information on the clinical drug trial registration and information disclosure platform. During the period of clinical drug trial, a sponsor shall continuously update the registration information and register the results of the clinical drug trial after the completion of the clinical drug trial. The registration information shall be publicized on the platform, and the sponsor shall be responsible for the authenticity of the registration information on clinical drug trial. | | 第三十三条 申办者应当在开展药物临床试验前在药物临床试验登记与信息公示平台登记药物临床试验方案等信息。药物临床试验期间，申办者应当持续更新登记信息，并在药物临床试验结束后登记药物临床试验结果等信息。登记信息在平台进行公示，申办者对药物临床试验登记信息的真实性负责。 |
| The specific requirements for registration and information disclosure of clinical drug trial shall be developed and announced by the Center for Drug Evaluation. | | 药物临床试验登记和信息公示的具体要求，由药品审评中心制定公布。 |
| Section 2 Drug marketing authorization | | 第二节 药品上市许可 |
| Article 34 After completing the pharmaceutical research, pharmacological and toxicological research, clinical drug trial, and other researches supporting the marketing registration of a drug, determining the quality standards, completing the verification of commercial large-scale production process, and making sound preparation for the acceptance of drug registration inspection and examination, an applicant shall file an application for drug marketing authorization, and submit relevant research materials in accordance with the requirements of the application materials. After the formal examination of the application materials, an application that satisfies the requirements shall be accepted. | | 第三十四条 申请人在完成支持药品上市注册的药学、药理毒理学和药物临床试验等研究，确定质量标准，完成商业规模生产工艺验证，并做好接受药品注册核查检验的准备后，提出药品上市许可申请，按照申报资料要求提交相关研究资料。经对申报资料进行形式审查，符合要求的，予以受理。 |
| Article 35 Where a generic drug, in vitro diagnostic reagent managed as a drug, or any other eligible circumstance assessed by an applicant to be unnecessary to conduct or impossible for conducting clinical drug trial and meeting the conditions for exempting clinical drug trial, the applicant may directly file an application for drug marketing authorization. The technical guiding principles and relevant specific requirements for exempting clinical drug trial shall be developed and announced by the Center for Drug Evaluation. | | 第三十五条 仿制药、按照药品管理的体外诊断试剂以及其他符合条件的情形，经申请人评估，认为无需或者不能开展药物临床试验，符合豁免药物临床试验条件的，申请人可以直接提出药品上市许可申请。豁免药物临床试验的技术指导原则和有关具体要求，由药品审评中心制定公布。 |
| A generic drug shall be consistent with the quality and efficacy of the reference preparation. An applicant shall, with reference to the relevant technical guiding principles, select reasonable reference preparations. | | 仿制药应当与参比制剂质量和疗效一致。申请人应当参照相关技术指导原则选择合理的参比制剂。 |
| Article 36 Under one of the following circumstances, an application for marketing authorization of an OTC drug may be directly filed: | | 第三十六条 符合以下情形之一的，可以直接提出非处方药上市许可申请： |
| (1) There is already an OTC drug marketed with the same active ingredients, indications (or functions), dosage forms and specifications as the drug within the territory of China. | | （一）境内已有相同活性成分、适应症（或者功能主治）、剂型、规格的非处方药上市的药品； |
| (2) The dosage form or specification is changed for an OTC drug determined by NMPA, but the indication (or function), dosage or route of medication of the drug is not changed. | | （二）经国家药品监督管理局确定的非处方药改变剂型或者规格，但不改变适应症（或者功能主治）、给药剂量以及给药途径的药品； |
| (3) A new compound preparation composed of active ingredients of an OTC drug determined by NMPA is used. | | （三）使用国家药品监督管理局确定的非处方药的活性成份组成的新的复方制剂； |
| (4) Other circumstances for directly filing an application for OTC drug marketing authorization. | | （四）其他直接申报非处方药上市许可的情形。 |
| Article 37 Where the generic name of a drug to be used for a drug for which an application has been filed is not listed in the national drug standards or drug registration standards, the applicant shall file an application for approval of the generic name when filing an application for drug marketing authorization. After an application for drug marketing authorization is accepted, the relevant materials for the approval of the generic name shall be transferred to the CHP, and the CHP shall report to the Center for Drug Evaluation after granting approval. | | 第三十七条 申报药品拟使用的药品通用名称，未列入国家药品标准或者药品注册标准的，申请人应当在提出药品上市许可申请时同时提出通用名称核准申请。药品上市许可申请受理后，通用名称核准相关资料转药典委，药典委核准后反馈药品审评中心。 |
| Where the generic name of a drug to be used for a drug for which an application has been filed has been listed in the national drug standards or drug registration standards and the Center for Drug Evaluation believes that the generic name of the drug needs to be approved during the evaluation process, the CHP shall be notified of approving the generic name and providing relevant materials, and the CHP shall report to the Center for Drug Evaluation after granting approval. | | 申报药品拟使用的药品通用名称，已列入国家药品标准或者药品注册标准，药品审评中心在审评过程中认为需要核准药品通用名称的，应当通知药典委核准通用名称并提供相关资料，药典委核准后反馈药品审评中心。 |
| The CHP shall, when approving a generic name of a drug, effectively conduct communication and exchange with the applicant, and notify the applicant of the approval result. | | 药典委在核准药品通用名称时，应当与申请人做好沟通交流，并将核准结果告知申请人。 |
| Article 38 The Center for Drug Evaluation shall organize pharmaceutical, medical and other technical personnel to evaluate the accepted applications for drug marketing authorization as required. | | 第三十八条 药品审评中心应当组织药学、医学和其他技术人员，按要求对已受理的药品上市许可申请进行审评。 |
| Where, during the evaluation process, the drug registration inspection and examination is initiated based on risks, the relevant technical institution shall complete the inspection and examination within the prescribed time limit. | | 审评过程中基于风险启动药品注册核查、检验，相关技术机构应当在规定时限内完成核查、检验工作。 |
| Where the Center for Drug Evaluation conducts comprehensive evaluation of the safety, effectiveness, and quality controllability of a drug based on the drug registration application materials, inspection results, and examination results, among others, the OTC drugs shall also be transferred to the Center for Drug Reevaluation for suitability examination of OTC drugs. | | 药品审评中心根据药品注册申报资料、核查结果、检验结果等，对药品的安全性、有效性和质量可控性等进行综合审评，非处方药还应当转药品评价中心进行非处方药适宜性审查。 |
| Article 39 Where the comprehensive evaluation conclusion is adopted, the drug shall be approved for marketing, and a drug registration certificate shall be issued. If the comprehensive evaluation conclusion is not adopted, a disapproval decision shall be made. A drug registration certificate shall specify the drug approval number, holder, manufacturer and other information. An OTC drug registration certificate shall also indicate the type of OTC drug. | | 第三十九条 综合审评结论通过的，批准药品上市，发给药品注册证书。综合审评结论不通过的，作出不予批准决定。药品注册证书载明药品批准文号、持有人、生产企业等信息。非处方药的药品注册证书还应当注明非处方药类别。 |
| The approved drug production process, quality standards, instructions and labels shall be sent to the applicant as an annex to the drug registration certificate, and the post-marketing drug research requirements shall also be annexed if necessary. The aforesaid information shall be included in the file of drug varieties and be updated in a timely manner according to the changes after marketing. | | 经核准的药品生产工艺、质量标准、说明书和标签作为药品注册证书的附件一并发给申请人，必要时还应当附药品上市后研究要求。上述信息纳入药品品种档案，并根据上市后变更情况及时更新。 |
| After a drug is approved for marketing, the holder shall produce the drug according to the production process and quality standards approved by NMPA, and specify and implement them according to the requirements of the management standards for drug production quality. | | 药品批准上市后，持有人应当按照国家药品监督管理局核准的生产工艺和质量标准生产药品，并按照药品生产质量管理规范要求进行细化和实施。 |
Article 40 Where, during the period of evaluation of an application for drug marketing authorization, there are major changes that may affect the safety, effectiveness, and quality controllability of the drug, the applicant shall withdraw the original application for registration and re-file an application after the supplementary research.
．．．．．． | | 第四十条 药品上市许可申请审评期间，发生可能影响药品安全性、有效性和质量可控性的重大变更的，申请人应当撤回原注册申请，补充研究后重新申报。
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