| | |
Order of the State Drug Administration
(No.35)
The Measures for the Administration of Drug Registration (for trial implementation) were adopted at the executive meeting of the State Drug Administration on October 15, 2002 and are hereby promulgated. These Measures shall come into force on December 1, 2002.
Director of the Administration: Zheng Xiaoyu
October 30, 2002
Measures for the Administration of Drug Registration (for trial implementation)
| | 国家药品监督管理局局令
（第35号）
《药品注册管理办法》（试行）于2002年10月15日经国家药品监督管理局局务会议审议通过，现予发布。本办法自2002年12月1日起施行。
局长：郑筱萸
二00二年十月三十日
药品注册管理办法(试行)
|
Chapter 1 General Principles
| | 第一章 总则
|
Article 1 In order to guarantee the safety, effectiveness and controllable quality of drugs, and to regulate the drug registration, these Measures are formulated in accordance with the Medicinal Product Administration Law of the People's Republic of China (hereinafter referred to as Medicinal Product Administration Law), and the Implementation Regulations of the Medicinal Product Administration Law of the People's Republic of China (hereinafter referred to as Implementation Regulations).
| | 第一条 为保证药品的安全、有效和质量可控，规范药品注册行为，根据《中华人民共和国药品管理法》（以下简称《药品管理法》）、《中华人民共和国药品管理法实施条例》（以下简称《药品管理法实施条例》），制定本办法。
|
Article 2 These Measures shall apply to the drug development and clinic study, the application for drug clinic study, drug manufacturing or import, as well as the relevant drug registration, inspection, supervision and administration undertaken within the People's Republic of China.
| | 第二条 在中华人民共和国境内从事药物研制和临床研究，申请药物临床研究、药品生产或者进口，以及进行相关的药品注册检验、监督管理，适用本办法。
|
Article 3 Drug registration shall refer to the examination and approval process by conducting systematic evaluation of the safety, effectiveness and controllability of quality of the drugs to be marketed, and by making the decision on whether or not to approve the drug clinic study, drug manufacturing or import, the process shall include the examination and approval of the contents indicated in the certifications of approval for application for drug alteration and in the attachments thereof.
| | 第三条 药品注册，是指依照法定程序，对拟上市销售的药品的安全性、有效性、质量可控性等进行系统评价，并作出是否同意进行药物临床研究、生产药品或者进口药品决定的审批过程，包括对申请变更药品批准证明文件及其附件中载明内容的审批。
|
Article 4 The state encourages the study and development of new drugs, and employs accelerated examination and approval for new drugs developed and new drugs treating complicated and serious diseases.
| | 第四条 国家鼓励研究创制新药，对创制的新药及治疗疑难危重疾病的新药实行快速审批。
|
Article 5 The State Drug Administration (hereinafter referred to as SDA) shall be in charge of the administration of drug registration throughout the country, and be responsible for the examination and approval of drug clinic study, drug manufacturing and import.
The drug administrations of the provinces, autonomous regions and municipalities directly under the Central Government shall, upon the entrustment by the SDA, examine the completeness, normalization and authenticity of the application materials for drug registration.
| | 第五条 国家药品监督管理局主管全国药品注册管理工作，负责对药物临床研究、药品生产和进口的审批。
省、自治区、直辖市药品监督管理局受国家药品监督管理局的委托，对药品注册申报资料的完整性、规范性和真实性进行审核。
|
Article 6 An applicant for drug registration (hereinafter referred to as applicant) shall refer to an institution that files the application for drug registration, bears the corresponding legal liabilities, and holds the certifications of approval for drugs after the application is approved. A domestic applicant shall be an institution with legal person status that legally registered within China, and an overseas applicant shall be a legal overseas drug manufacturer. For an overseas applicant, its work office stationed in China or an agency within China commissioned by it shall make the drug registration for it.
The personnel handling the applications for drug registration shall be the corresponding professionals, and shall be familiar with the laws and regulations on and the technical requirements for the administration of drug registration.
| | 第六条 药品注册申请人（以下简称申请人），是指提出药品注册申请，承担相应法律责任，并在该申请获得批准后持有药品批准证明文件的机构。境内申请人应当是在中国境内合法登记的法人机构，境外申请人应当是境外合法制药厂商。境外申请人办理进口药品注册，应当由其驻中国境内的办事机构或者由其委托的中国境内代理机构办理。
办理药品注册申请事务的人员应当是相应的专业技术人员，并熟悉药品注册管理法律、法规和技术要求。
|
Chapter 2 Application for Drug Registration
| | 第二章 药品注册的申请
|
Article 7 Application for drug registration shall include the application for new drugs, application for drugs with existing state standards, application for imported drugs, and the supplementary application thereof. For a domestic applicant, the procedures for application for new drugs and application for drugs with existing state standards shall be followed, for an overseas applicant, the procedures for application for imported drugs shall be followed.
| | 第七条 药品注册申请包括新药申请、已有国家标准药品的申请和进口药品申请及其补充申请。境内申请人按照新药申请、已有国家标准药品的申请办理，境外申请人按照进口药品申请办理。
|
Article 8 Application for new drugs shall refer to the application for registration of drugs that haven't been marketed within China. If the type of preparation or the route of administration of any drugs that have been marketed is changed, the said drugs shall be administered as new drugs.
Application for drugs with existing state standards shall refer to the application for registration of the drugs for which the SDA has promulgated official standards.
Application for imported drugs shall refer to the application for registration of the drugs that are manufactured overseas and marketed in China.
Supplementary application shall refer to the application for alteration, adding or cancellation of the approved matters or contents after the applications for new drugs, drugs with existing state standards or imported drugs have been approved. If an application for registration of the drugs during the examination and approval or an approved application for clinical study needs to be altered correspondingly, or if transferring the new drug technologies, repackaging the imported drugs, and formalizing the tentative drug standards, the procedures for supplementary application shall be followed.
| | 第八条 新药申请，是指未曾在中国境内上市销售药品的注册申请。已上市药品改变剂型、改变给药途径的，按照新药管理。
已有国家标准药品的申请，是指生产已经由国家药品监督管理局颁布的正式标准的药品注册申请。
进口药品申请，是指在境外生产的药品在中国上市销售的注册申请。
补充申请，是指新药申请、已有国家标准药品的申请或者进口药品申请经批准后，改变、增加或取消原批准事项或内容的注册申请。审批过程中的药品注册申请、已批准的临床研究申请需进行相应变更的，以及新药技术转让、进口药品分包装、药品试行标准转正，按补充申请办理。
|
Article 9 An applicant shall file the application for drug registration with the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, and shall submit the relevant materials and drug samples; in case of an application for registration of imported drugs, the applicant shall file the application with the SDA.
| | 第九条 申请药品注册，申请人应当向所在地省、自治区、直辖市药品监督管理局提出，并报送有关资料和药物实样；其中申请进口药品注册，申请人应当向国家药品监督管理局提出。
|
Article 10 If two or more entities apply for registration of new drugs as a joint applicant, they shall file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where the drug manufacturing enterprise is located; if the applicant entities are all drug manufacturing enterprises, they shall file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where the drug manufacturing enterprise that applies for the preparation is located; if none of the applicant entities are drug manufacturing enterprises, they shall file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where the sample is trial-produced.
| | 第十条 两个以上单位共同作为新药申请人的，应当向其中药品生产企业所在地省、自治区、直辖市药品监督管理局提出申请；申请单位均为药品生产企业的，应当向申请制剂的药品生产企业所在地省、自治区、直辖市药品监督管理局提出申请；申请单位均不是药品生产企业的，应当向样品试制现场所在地省、自治区、直辖市药品监督管理局提出申请。
|
Article 11 For the drugs applying for registration or the prescriptions or techniques used, the applicant shall provide the patent in China and explanations on its ownership, submit a guaranty of no infringement upon the patents of others, and promise to be responsible for the possible infringement consequences.
| | 第十一条 申请人应当对所申请注册的药物或者使用的处方、工艺等，提供在中国的专利及其权属状态说明，并提交对他人的专利不构成侵权的保证书，承诺对可能的侵权后果负责。
|
Article 12 Where any dispute arises after the application for drug registration is approved, the parties shall settle the dispute through consultation by themselves, or through judicial bodies or patent administrative bodies pursuant to the relevant laws and regulations.
| | 第十二条 药品注册申请批准后发生专利权纠纷的，当事人应当自行协商解决，或者依照有关法律、法规的规定，通过司法机关或者专利行政机关解决。
|
Article 13 With respect to any drug to which a Chinese patent has been granted, other applicants may file an application for registration within 2 years before the expiration of the patent of that drug. The SDA shall make examination pursuant to these Measures, and, if the provisions are met, approve the manufacturing or import after the patent expires.
| | 第十三条 已获得中国专利的药品，其他申请人在该药品专利期满前2年内可以提出注册申请。国家药品监督管理局按照本办法予以审查，符合规定的，在专利期满后批准生产或者进口。
|
Article 14 According to Article 35 of the Implementation Regulations, with respect to the undisclosed experiment data or other data independently obtained and submitted by the manufacturer or seller that has acquired the license for manufacturing or selling drugs containing new chemical compounds, the SDA shall not approve any application for using such undisclosed data without the consent of the licensed applicant within 6 years from the day of approval for the license. But if other applicants submit the data independently obtained by themselves, the SDA may approve them.
When applying for drug registration, other applicants shall promise that all the experiment data are independently obtained by themselves and shall guarantee the authenticity of the data.
| | 第十四条 按照《药品管理法实施条例》第三十五条的规定，对获得生产或者销售含有新型化学成份药品许可的生产者或者销售者提交的自行取得且未披露的试验数据和其他数据，国家药品监督管理局自批准该许可之日起6年内，对其他未经已获得许可的申请人同意，使用其未披露数据的申请不予批准。但是其他申请人提交自行取得数据的除外。
其他申请人在提出药品注册申请时，应当承诺所有试验数据均为自行取得并保证其真实性。
|
Article 15 With respect to the drugs processed in China upon the commission of overseas drug manufacturers, but not sold or used in China, the domestic drug manufacturing enterprise that processes the drug shall file the application with the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located. The drug administration of the province, autonomous region or municipality directly under the Central Government shall approve the application if the provisions are met, but shall not issue the registered number of approval for the drug.
| | 第十五条 接受境外制药厂商的委托，在我国进行加工药品，但不在境内销售使用的，由进行加工的境内药品生产企业向所在地省、自治区、直辖市药品监督管理局提出申请。符合规定的，省、自治区、直辖市药品监督管理局予以批准，但不发给药品批准文号。
|
Chapter 3 Investigational Study of New Drugs before They Are Clinically Used
| | 第三章 药物的临床前研究
|
Article 16 Investigational study of new drugs conducted for application for drug registration shall include the synthetic techniques, extraction methods, physical and chemical properties, purity, choosing of form of this drug, selection of prescriptions, preparation techniques, inspection methods, quality indications and stability, pharmacology, toxicology, nuclein animal dynamics etc. As for Chinese medicine preparations, the sources and processing of the original medicine materials etc shall also be included; as for biologic products, the quality standard, preservation conditions, inheritance stability and immunological study of the initial materials such as microbial and toxic species, cell line or organism etc shall also be included.
| | 第十六条 为申请药品注册而进行的药物临床前研究，包括药物的合成工艺、提取方法、理化性质及纯度、剂型选择、处方筛选、制备工艺、检验方法、质量指标、稳定性，药理、毒理、动物药代动力学等。中药制剂还包括原药材的来源、加工及炮制等；生物制品还包括菌毒种、细胞株、生物组织等起始材料的质量标准、保存条件、遗传稳定性及免疫学的研究等。
|
Article 17 Relevant administration provisions shall be executed in the Investigational study of new drugs, and the Criterions for the Quality Control of Non-clinical Study of Drugs must be executed in the safety evaluation study.
| | 第十七条 药物临床前研究应当执行有关管理规定，其中安全性评价研究必须执行《药物非临床研究质量管理规范》。
|
Article 18 An institution engaging in drug study and development must have the personnel, site, equipment, instruments and management system accommodating to the experiment and study projects; the animals, reagents, and raw materials for experiment use shall meet the relevant provisions and requirements of the state, and the authenticity of all the experiment data and materials shall be guaranteed.
| | 第十八条 从事药物研究开发的机构必须具有与试验研究项目相适应的人员、场地、设备、仪器和管理制度；所用试验动物、试剂和原材料应当符合国家有关规定和要求，并应当保证所有试验数据和资料的真实性。
|
Article 19 For a separate application for the chemical raw material medicines used in the drug preparations and for the Chinese medicine materials and the crude slices of Chinese medicine subject to the administration by the registered number of approval, the registered number of approval for the drug, the Registration Certificate of Imported Drugs or the Registration Certificate of Pharmaceutical Products is required, the raw material medicines must be obtained through legal channels. Where the raw material medicines don't have the registered number of approval, the Registration Certificate of Imported Drugs or the Registration Certificate of Pharmaceutical Products, the approval of the SDA is required.
| | 第十九条 单独申请药物制剂所使用的化学原料药及实施批准文号管理的中药材和中药饮片，必须具有药品批准文号、《进口药品注册证》或者《医药产品注册证》，该原料药必须通过合法的途径获得。所用原料药不具有药品批准文号、《进口药品注册证》或者《医药产品注册证》的，必须经国家药品监督管理局批准。
|
Article 20 Where an applicant entrusts any other institution to conduct drug study, separate experiment, testing, trial manufacturing or production of samples etc, it shall sign a contract with the trustee. The applicant shall be responsible for the authenticity of the drug study data in the application materials.
| | 第二十条 申请人委托其他机构进行药物研究或者进行单项试验、检测、样品的试制、生产等，应当与被委托方签定合同。申请人应当对申报资料中的药物研究数据的真实性负责。
|
Article 21 If the application materials for drug registration include any drug experiment and study materials submitted by any overseas drug study institution, there must be attached explanations produced by that overseas drug study institution on the projects and page numbers of the materials provided, and the certifications which can prove that the institution has been legally registered and notarized overseas, and the attached materials may be used as the application materials only after they have been acknowledged by the SDA. The SDA shall send personnel to make on-spot examinations according to the needs.
| | 第二十一条 药品注册申报资料中有境外药物研究机构提供的药物试验研究资料的，必须附有境外药物研究机构出具的其所提供资料的项目、页码的情况说明和证明该机构已在境外合法登记并经公证的证明文件，经国家药品监督管理局认可后，方可作为药品注册申请的申报资料。国家药品监督管理局根据审查需要派员进行现场考察。
|
Article 22 When inspecting drug study according to the needs, the SDA and the drug administrations of a province, autonomous region or municipality directly under the Central Government may request the applicant or the drug study institution undertaking the experiment to conduct repeated experiment according to the projects, methods and data specified in the application materials, and shall send personnel to examine the experiment on the spot; or an institute for drug control or other drug study institution may be entrusted to make the repeated experiment.
| | 第二十二条 国家药品监督管理局和省、自治区、直辖市药品监督管理局根据需要对研究情况进行核查，要求申请人或者承担试验的药物研究机构按照其申报资料的项目、方法和数据进行重复试验，并派员现场考察试验过程；也可以委托药品检验所或者其他药物研究机构进行重复试验。
|
Article 23 Investigational study of new drugs shall be conducted by referring to the relevant technical guiding principles promulgated by the SDA. Where the applicant adopts other evaluation methods and techniques in the experiment, it shall submit the materials that can prove the scientificity of such methods and techniques.
| | 第二十三条 药物临床前研究应当参照国家药品监督管理局发布的有关技术指导原则进行。申请人采用其他的评价方法和技术进行试验的，应当提交能证明其科学性的资料。
|
Chapter 4 Clinical Study of Drugs
| | 第四章 药物的临床研究
|
Section 1 Basic Requirements
| | 第一节 基本要求
|
Article 24 Clinical study of drugs includes clinical trial and bioequivalence trial.
Clinical study of drugs must be approved by the SDA before it is carried out, and must follow the Criterions for the Quality Control of Clinical Trial of Drugs.
| | 第二十四条 药物的临床研究包括临床试验和生物等效性试验。
药物临床研究必须经国家药品监督管理局批准后实施，必须执行《药物临床试验质量管理规范》。
|
Article 25 For the application for registration of new drugs, clinical trial or bioequivalence trial shall be conducted.
Generally, it is not necessary to conduct clinical study for the application for registration of drugs with existing state standards. If clinical study is needed, as for the chemical drugs, the applicant may conduct only the bioequivalence trial; as for Chinese traditional patent medicines and biological products the quality of which needs to be controlled by techniques and standards, the clinical trial shall be conducted.
In supplementary application, it is needed to conduct clinical study if new indications are added for any drug already on the market or if the manufacturing techniques of the drug are altered significantly.
| | 第二十五条 申请新药注册，应当进行临床试验或者生物等效性试验。
申请已有国家标准的药品注册，一般不需要进行临床研究。需要进行临床研究的，化学药品可仅进行生物等效性试验；需要用工艺和标准控制药品质量的中成药和生物制品，应当进行临床试验。
在补充申请中，已上市药品增加新适应症或者生产工艺等有重大变化的，需要进行临床研究。
|
Article 27 Clinical trial is divided into phases I、II、III、and IV. For the application for registration of new drugs, Clinical trial of phases I、II、and III shall be conducted, under certain circumstances, the applicant may only conduct clinical trial of phases II and III or only phase III.
Phase I clinical trial: preliminary trial on clinical pharmacology and human body safety evaluation, which observes the degree of tolerance of human body against the new drug and the drug dynamics, and provides basis for working out the administration scheme.
Phase II clinical trial: preliminary evaluation of the treating effect, the purpose of which is to preliminarily evaluate the treating effect and safety of the drug on the target patient with the applicable disease, and also to provide basis for the determination of study design and dosage administration scheme for phase III clinical trial. Various forms may be employed for the study design of this phase in accordance with the specific study purpose, including randomized controlled clinical trial.
Phase III clinical trial: confirmation phase of the treating effect, the purpose of which is to further verify the treating effect and safety of the drug on the target patient with the applicable disease, to evaluate the relationship between interest and risk, and to eventually provide adequate basis for the application for drug registration for gaining approval. Generally, the trial shall be a randomized controlled trial with sufficient samples.
Phase IV clinical experiment: application study conducted by the applicant independently after the new drug comes into the market, the purpose of which is to examine the curative effect of the drug and the adverse reactions when it is widely used; to evaluate the relationship between interest and risk when the drug is used in ordinary or special groups; and to improve the dosage administration etc.
| | 第二十六条 临床试验分为I、II、III、IV期。申请新药注册应当进行I、II、III期临床试验，有些情况下可仅进行II期和III期，或者III期临床试验。
I期临床试验：初步的临床药理学及人体安全性评价试验。观察人体对于新药的耐受程度和药代动力学，为制定给药方案提供依据。
II期临床试验：治疗作用初步评价阶段。其目的是初步评价药物对目标适应症患者的治疗作用和安全性，也包括为III期临床试验研究设计和给药剂量方案的确定提供依据。此阶段的研究设计可以根据具体的研究目的，采用多种形式，包括随机盲法对照临床试验。
III期临床试验：治疗作用确证阶段。其目的是进一步验证药物对目标适应症患者的治疗作用和安全性，评价利益与风险关系，最终为药物注册申请获得批准提供充分的依据。试验一般应为具有足够样本量的随机盲法对照试验。
IV期临床试验：新药上市后由申请人自主进行的应用研究阶段。其目的是考察在广泛使用条件下的药物的疗效和不良反应；评价在普通或者特殊人群中使用的利益与风险关系；改进给药剂量等。
|
Article 27 The number of cases experimented in drug clinical study shall be in accordance with the study purpose and meet the relevant statistics requirements and the minimum clinical study case number specified in these Measures. As for rare diseases, special diseases or other circumstances where it is needed to reduce clinical study cases or to exempt the clinical trial, examination and approval by the SDA is required.
| | 第二十七条 药物临床研究的受试例数应当根据临床研究的目的，符合相关统计学的要求和本办法所规定的最低临床研究病例数要求。罕见病、特殊病种及其他情况，要求减少临床研究病例数或者免做临床试验的，必须经国家药品监督管理局审查批准。
|
Article 28 With respect to bacterins or other special drugs prepared at the phase of seed selection of bacterial or toxic species, if there are no suitable animal models and the laboratories can not evaluate the curative effect thereof, the applicant may apply for clinical study with the SDA on the premise that the safety of the experimented person is secured.
| | 第二十八条 在菌毒种选种阶段制备的疫苗或者其他特殊药物，无合适的动物模型且试验室无法评价其疗效的，在保证受试者安全的前提下，可以向国家药品监督管理局申请临床研究。
|
Section 2 Requirements Before the Study
| | 第二节 实施前的要求
|
Article 29 After a drug clinical study has been approved, the applicant shall select, from the institutions qualified for drug clinical trial, an institution to undertake the drug clinical trial, decide on, through consultation, the entity responsible for the clinical study, the major researchers and the entities participating in the clinical study.
| | 第二十九条 药物临床研究批准后，申请人应当从具有药物临床试验资格的机构中，选择承担药物临床试验的机构，商定临床研究的负责单位、主要研究者及临床研究参加单位。
|
Article 30 The applicant shall sign a clinical study contract with the selected entity responsible for and the entities participating in the clinical study, supply the draft of letter of consent with knowledge of the experimented person and the manuals for the researchers conducting the clinical trial, perfect the clinical study scheme by referring to the relevant technical guiding principles, and request the ethic committee of the clinical trial institution to examine the scientificity of the clinical study and the ethic issues involved.
| | 第三十条 申请人应当与选定的临床研究负责和参加单位签定临床研究合同，提供受试者知情同意书样稿和临床试验研究者手册，参照有关技术指导原则完善临床研究方案，并提请临床试验机构伦理委员会对临床研究方案的科学性和涉及的伦理问题进行审查。
|
Article 31 The applicant shall provide the selected clinical study entities with free medicines for use in clinical study and drugs for comparison use (except for phase IV clinical trial), enclose the sample inspection report; and bear the expenses needed for the clinical study.
| | 第三十一条 申请人应当向选定的临床研究单位免费提供临床研究用药物和对照用药品（IV期临床试验除外），并附样品检验报告书；承担临床研究所需要的费用。
|
Article 32 Drugs for use in clinical study shall be prepared in workshops meeting the conditions provided for in the Criterions for the Quality Control of Drug Manufacturing. The preparing process shall strictly follow the Criterions for the Quality Control of Drug Manufacturing.
The SDA or the entrusted drug administration of the province, autonomous region or municipality directly under the Central Government may make on-spot examinations according to the needs.
| | 第三十二条 临床研究用药物，应当在符合《药品生产质量管理规范》条件的车间制备。制备过程应当严格执行《药品生产质量管理规范》的要求。
国家药品监督管理局或者委托省、自治区、直辖市药品监督管理局，根据审查需要进行现场考察。
|
Article 33 An applicant may inspect the drugs for use in clinical study by itself according to the drug standards determined by the SDA, either may it entrust the National Institute for the Control of Pharmaceutical and Biological Products or an institute for drug control designated by the SDA to make the inspection, the drugs can be used in clinical study only after they have passed the inspection. The SDA may designate an institute for drug control to make selective inspection over the drugs for use in the clinical study.
Vaccine products and blood products, and other biological products as well as overseas-manufactured drugs for use in clinical study provided for by the SDA, must be inspected by the institutes for drug control designated by the SDA, and can be used in clinical study only after they have passed the inspection. The applicant shall bear all the responsibilities for the quality of the drugs for clinical study use.
| | 第三十三条 申请人可以按照国家药品监督管理局审定的药品标准自行检验临床研究用药物，也可以委托中国药品生物制品检定所或者国家药品监督管理局指定的药品检验所进行检验，检验合格后方可用于临床研究。国家药品监督管理局可以指定药品检验所对临床研究用的药物进行抽查检验。
疫苗类制品、血液制品、国家药品监督管理局规定的其他生物制品以及境外生产的临床研究用药物，必须经国家药品监督管理局指定的药品检验所检验，合格后方可用于临床研究。申请人对临床研究用药物的质量负有全部责任。
|
Article 34 An applicant shall, before carrying out the clinical study of drugs, submit the clinical study scheme and the names of the principal researchers of the entity responsible for the clinical study, the list of the participating entities and the researchers thereof, the letter of approval of the ethics committee, the sample of the letter of consent with knowledge to the SDA for record, and shall submit them to the drug administrations of the provinces, autonomous regions or municipalities directly under the Central Government where the clinical study entities are located.
| | 第三十四条 申请人在药物临床研究实施前，应当将已确定的临床研究方案和临床研究负责单位的主要研究者姓名、参加研究单位及其研究者名单、伦理委员会审核同意书、知情同意书样本等报送国家药品监督管理局备案，并报送临床研究单位所在地省、自治区、直辖市药品监督管理局。
|
Section 3 Administration of Clinical Study
| | 第三节 临床研究的管理
|
Article 35 In the clinical study of drugs, the applicant shall appoint personnel with certain professional knowledge to supervise the implementation of the Criterions for the Quality Control of Clinical Trial of Drugs.
| | 第三十五条 药物临床研究过程中，申请人应当指定具有一定专业知识的人员监督执行《药物临床试验质量管理规范》。
|
Article 36 If an applicant finds out that any clinical researcher violates the relevant provisions or fails to carry out the clinical study scheme, it shall urge the researcher to correct; if the circumstances are serious, it may demand suspension or termination of the clinical study, and shall report to the SDA and the drug administration of the relevant province, autonomous region or municipality directly under the Central Government.
| | 第三十六条 申请人发现临床研究者违反有关规定或者未按照临床研究方案执行的，应当督促其改正；情节严重的，可以要求暂停临床研究，或者终止临床研究，并将情况报告国家药品监督管理局和有关省、自治区、直辖市药品监督管理局。
|
Article 37 After finishing each phase of clinical trial, the applicant shall submit the clinical study and statistics analysis report to the SDA and to the drug administration of the relevant province, autonomous region or municipality directly under the Central Government.
If the period of clinical study exceeds 1 year, the applicant shall submit a report on the clinical study process to the SDA and the drug administration of the relevant province, autonomous region or municipality directly under the Central Government.
| | 第三十七条 申请人完成每期临床试验后，应当向国家药品监督管理局和有关省、自治区、直辖市药品监督管理局提交临床研究和统计分析报告。
临床研究时间超过1年的，申请人应当自批准之日起每年向国家药品监督管理局和有关省、自治区、直辖市药品监督管理局提交临床研究进展报告。
|
Article 38 The clinical study of drugs shall be carried out within 2 years from the day of approval. If it hasn't been carried out within that period, the original certifications of approval shall be invalidated automatically; a new application shall be filed if it is still needed to carry out the clinical study.
| | 第三十八条 药物临床研究被批准后应当在2年内实施。逾期未实施的，原批准证明文件自行废止；仍需进行临床研究的，应当重新申请。
|
Article 39 The entities and personnel participating in the clinical study shall be familiar with the properties, functions, curative effect and safety of the drugs for clinical trial use; understand the responsibilities and obligations of clinical researchers; obtain the letter of consent with knowledge voluntarily signed by the experimented person; and make the clinical study records timely, accurately and truthfully.
| | 第三十九条 参加临床研究的单位及人员应当熟悉供临床试验用药物的性质、作用、疗效和安全性；了解临床研究者的责任和义务；获得由受试者自愿签署的知情同意书；及时、准确、真实地做好临床研究记录。
|
Article 40 If an applicant violates the Criterions for the Quality Control of Clinical Trial of Drugs or requests to change the data or conclusion of the trial, the entities and personnel participating in the clinical study shall report to the drug administration of the relevant province, autonomous region or municipality directly under the Central Government and the SDA.
| | 第四十条 参加临床研究的单位及人员，对申请人违反《药物临床试验质量管理规范》或者要求改变试验数据、结论的，应当向所在地省、自治区、直辖市药品监督管理局和国家药品监督管理局报告。
|
Article 41 The entities undertaking the clinical study and the clinical researchers are obliged to take necessary measures to guarantee the safety of the experimented person.
Clinical researchers shall pay close attention to the occurrence of any adverse reaction case involving the drugs for clinical study use, take proper treating measures for the experimented person without delay, and write the case into the records.
If any serious adverse reaction case occurs in the course of a clinical study, the researchers shall, within 24 hours, report to the drug administration of the relevant province, autonomous region or municipality directly under the Central Government and the SDA, and shall make a timely report to the ethics committee.
| | 第四十一条 承担临床研究的单位和临床研究者，有义务采取必要的措施，保障受试者的安全。
临床研究者应当密切注意临床研究用药物不良事件的发生，及时对受试者采取适当的处理措施，并记录在案。
临床研究过程中发生严重不良事件的，研究者应当在24小时内报告有关省、自治区、直辖市药品监督管理局和国家药品监督管理局及申请人，并及时向伦理委员会报告。
|
Article 42 For the clinical studies that have been approved, the SDA and the drug administrations of the relevant provinces, autonomous regions and municipalities directly under the Central Government shall conduct regular or specific on-spot examinations or data checks.
| | 第四十二条 对已批准的临床研究，国家药品监督管理局和省、自治区、直辖市药品监督管理局应当进行常规的或者有因的现场考察或者数据稽查。
|
Article 43 If any of the following cases occurs in the course of a clinical study, the SDA may request the applicant to modify the clinical study scheme, or to suspend or terminate the clinical study:
| | 第四十三条 临床研究期间发生下列情形之一的，国家药品监督管理局可以要求申请人修改临床研究方案、暂停或者终止临床研究：
|
(1) The ethics committee fails to perform its duties;
| | （一）伦理委员会未履行职责的；
|
(2) Safety of the experimented person can't be effectively guaranteed;
| | （二）不能有效保证受试者安全的；
|
(3) A serious adverse reaction case hasn't been reported within the prescribed time limit;
| | （三）未按照规定时限报告严重不良事件的；
|
(4) Report on the clinical study progress is not submitted in timely and truthfully;
| | （四）未及时、如实报送临床研究进展报告的；
|
(5) Approved clinical study fails to acquire evaluable results within 2 years after the scheduled end of the study;
| | （五）已批准的临床研究超过原预定研究结束时间2年仍未取得可评价结果的；
|
(6) There is, already, evidence proving that the drugs for clinical trial use are ineffective;
| | （六）已有证据证明临床试验用药物无效的;
|
(7) Drugs for clinical trial use encounter quality problems;
| | （七）临床试验用药物出现质量问题的；
|
(8) Frauds are committed in the clinical study;
| | （八）临床研究中弄虚作假的；
|
(9) Other cases of violation of the Criterions for the Quality Control of Clinical Trial of Drugs.
| | （九）违反《药物临床试验质量管理规范》其他情况的。
|
Article 44 Where the SDA makes the decision of modifying the clinical study scheme, ordering suspension or termination of the clinical study, the applicant or the entity conducting the clinical study shall execute such decision. If they have any objections, they may present their opinions within 10 days and explain the reasons in written form.
| | 第四十四条 国家药品监督管理局作出修改临床研究方案、责令暂停或者终止临床研究的决定，申请人或者临床研究单位应当执行。有异议的，可以在10日内提出意见并书面说明理由。
|
Article 45 If large-scope and unanticipated adverse reactions or serious adverse reaction cases occur in a clinical study, or there has been evidence that can prove the drugs for clinical trial use have serious quality problems, the SDA or the drug administration of the relevant province, autonomous region or municipality directly under the Central Government may take urgent measures and order suspension or termination of the clinical study, the applicant and the clinical study entity must stop the clinical study immediately.
| | 第四十五条 临床研究中出现大范围、非预期的不良反应或者严重不良事件时，或者有证据证明临床研究用药物存在严重质量问题时，国家药品监督管理局或者省、自治区、直辖市药品监督管理局可以采取紧急控制措施，责令暂停或者终止临床研究，申请人和临床研究单位必须立即停止临床研究。
|
Article 46 The use of drugs for clinical trial use shall be taken care of by the clinical researchers. The researches must guarantee that all the drugs for study use are only used on the experimented persons, and the method of use and dosage shall conform to the study scheme. The researchers may not pass the drugs for study use to any person not participating in the clinical study. Drugs for clinical study use may not be marketed.
| | 第四十六条 临床研究用药物的使用由临床研究者负责。研究者必须保证所有研究用药物仅用于该临床研究的受试者，其用法与用量应当符合研究方案。研究者不得把研究用药物转交任何非临床研究参加者。临床研究用药物不得销售。
|
Article 47 If an overseas applicant wishes to conduct an international multi-center clinical study of drugs, it shall file an application with the SDA pursuant to these Measures and meet the requirements of the following provisions:
| | 第四十七条 境外申请人在中国进行国际多中心药物临床研究的，应当按照本办法向国家药品监督管理局提出申请，并符合下列规定：
|
(1) The drugs for clinical study use shall be drugs that have been registered overseas or have entered Phase II clinical trial; the SDA will not accept any application filed by an overseas applicant for international multi-center clinical study of new preventive vaccine drugs not yet registered overseas;
| | （一）临床研究用药物应当是已在境外注册的药品或者已进入II期临床试验的药物；国家药品监督管理局不受理境外申请人提出的尚未在境外注册的预防用疫苗类新药的国际多中心药物临床研究申请；
|
(2) The SDA may, when granting approval for the conduction of international multi-center clinical study of drugs, request the applicant to carry out Phase I clinical trial in China according to the needs;
| | （二）国家药品监督管理局在批准进行国际多中心药物临床研究的同时，可以根据需要，要求申请人在中国首先进行I期临床试验；
|
(3) In the conduction of international multi-center clinical study of drugs in China, if serious adverse reactions and unanticipated adverse reactions relating to such drugs are found in any country, the applicant shall report to the SDA timely pursuant to the relevant provisions;
| | （三）在中国进行国际多中心药物临床研究时，在任何国家发现与该药物有关的严重不良反应和非预期不良反应，申请人应当按照有关规定及时报告国家药品监督管理局；
|
(4) After a clinical study is ended, the applicant shall submit the complete clinical study report to the SDA;
| | （四）临床研究结束后，申请人应当将完整的临床研究报告报送国家药品监督管理局；
|
(5) Where the data obtained in an international multi-center clinical study of drugs are used in the application for drug registration in China, the provisions relating to clinical study provided for in the Medicinal Product Administration Law, the Implementation Regulations, and these Measures must be met, and the applicant must submit all the study materials of the international multi-center clinical study.
| | （五）国际多中心药物临床研究取得的数据，用于在中国进行药品注册申请，必须符合《药品管理法》、《药品管理法实施条例》及本办法有关临床研究的规定，申请人必须提交多中心临床研究的全部研究资料。
|
Chapter 5 Application and Examination & Approval of New Drugs
| | 第五章 新药的申报与审批
|
Section 1 Basic Requirements
| | 第一节 基本要求
|
Article 48 The materials submitted for the application for registration of new drugs shall be complete and normative, and the data must be true and reliable; the documentary materials quoted shall be marked with the title of the work, title of the publication, as well as the volume, issue and page etc; the documentary materials not publicly published shall be accompanied with the certifications of permission of use by the owner of the materials. Materials in foreign languages shall be accompanied with Chinese translations pursuant to the requirements.
| | 第四十八条 申请新药注册所报送的资料应当完整、规范，数据必须真实、可靠；引用文献资料应当注明著作名称、刊物名称及卷、期、页等；未公开发表的文献资料应当提供资料所有者许可使用的证明文件。外文资料应当按照要求提供中文译本。
|
Article 49 The SDA shall make an accelerated examination and approval with respect to the applications for the following new drugs:
| | 第四十九条 国家药品监督管理局对下列新药申请可以实行快速审批：
|
(1) New Chinese medicine materials, effective components extracted from Chinese medicines or natural drugs, as well as the preparations of those components;
| | （一）新的中药材及其制剂，中药或者天然药物中提取的有效成份及其制剂；
|
(2) Chemical raw materials medicines, as well as the preparations and biological products thereof, that haven't been approved to be marketed home and abroad;
| | （二）未在国内外获准上市的化学原料药及其制剂、生物制品；
|
(3) New drugs that fight against AIDS virus and that are used in the diagnosis and prevention of AIDS, new drugs treating malignant tumours and rare diseases etc;
| | （三）抗艾滋病病毒及用于诊断、预防艾滋病的新药，治疗恶性肿瘤、罕见病等的新药；
|
(4) New drugs treating the diseases that can't be cured by effective means yet.
| | （四）治疗尚无有效治疗手段的疾病的新药。
|
Article 50 The drug administration of a province, autonomous region and municipality directly under the Central Government shall, after receiving an application for registration of any new drug listed in Article 49 of these Measures, make the examination and give opinions on whether that application meets the conditions for accelerated examination and approval. The SDA shall determine whether to make an accelerated examination and approval for that application for new drug upon the acceptance of it.
| | 第五十条 省、自治区、直辖市药品监督管理局在收到本办法 第四十九条所列新药的注册申请后，应当就该申请是否符合快速审批的条件进行审查并提出意见。国家药品监督管理局在受理时，确定是否对该新药申请实行快速审批。
|
Article 51 With respect to any new drug jointly developed by several entities, the application for registration may be filed by one entity among them, and the other entities may not file the application any more. Except the drugs listed in Items 1) and 2) of Article 49 of these Measures, after the application for a new drug is approved, each category of such drug may only be manufactured by one entity, and different specs of the same category may not be manufactured by different entities.
| | 第五十一条 多个单位联合研制的新药，可以由其中的一个单位申请注册，其他的单位不得重复申请。需要联合申请注册的，应当共同署名作为该新药的申请人。除本办法第四十九条（一）、（二）规定的药物外，新药申请批准后每个品种只能由一个单位生产，同一品种的不同规格不得分由不同单位生产。
|
Article 52 In the examination process of a new drug, if the technical requirements for that new drug are changed because the same category of drug is allowed to go on the market overseas, the original technical requirements shall remain unchanged.
| | 第五十二条 在新药审批期间，新药的技术要求由于相同品种在境外获准上市而发生变化的，维持原技术要求不变。
|
Section 2 Examination & Approval of Clinical Study of New Drugs
| | 第二节 新药临床研究的审批
|
Article 53 After finishing the investigational study of new drugs, an applicant shall fill in the Application Form for Drug Registration, and faithfully submit the relevant materials and drug samples to the drug administrations of the province, autonomous region or municipality directly under the Central Government.
| | 第五十三条 申请人完成临床前研究后，填写《药品注册申请表》，向所在地省、自治区、直辖市药品监督管理局如实报送有关资料和药物实样。
|
Article 54 The drug administration of the province, autonomous region or municipality directly under the Central Government shall make an examination of form of the application materials, organize an on-spot investigation of the manufacturing process and conditions, select samples for inspection use, and send notice on registration inspection to the designated institute for drug control. The administration shall, after finishing the aforesaid work, submit the examination opinions, investigation report and application materials to the SDA, and notify the applicant.
| | 第五十四条 省、自治区、直辖市药品监督管理局应当对申报资料进行形式审查，组织对研制情况及条件进行现场考察，抽取检验用样品，并向指定的药品检验所发出注册检验通知。完成上述工作后将审查意见、考察报告及申报资料报送国家药品监督管理局，并通知申请人。
|
Article 55 The institute for drug control receiving the notice on registration inspection shall make an inspection on the selected samples, check the drug standards of the application, and submit the inspection report and check opinions to the SDA within the prescribed time limit, and shall send those documents to the drug administration of the province, autonomous region or municipality directly under the Central Government that sent the notice on inspection and to the applicant.
| | 第五十五条 接到注册检验通知的药品检验所对抽取的样品进行检验，对申报的药品标准进行复核，并在规定的时限内将检验报告书和复核意见报送国家药品监督管理局，同时报送通知其检验的省、自治区、直辖市药品监督管理局和申请人。
|
Article 56 With respect to the application materials for clinical study of new drugs submitted by the drug administration of the province, autonomous region or municipality directly under the Central Government, the SDA shall accept the application if the requirements are met after examination, issue the notice on acceptance, and may request the applicant to supply drug samples if necessary.
| | 第五十六条 国家药品监督管理局对省、自治区、直辖市药品监督管理局报送的新药临床研究申请资料，经审查符合要求的，予以受理，发给受理通知单，必要时可以要求申请人提供药物实样。
|
Article 57 After accepting an application for new drugs, the SDA shall organize professionals in pharmacology, medicine and other technical fields to make the technical evaluation of the new drugs, and decide on whether or not to approve the clinical study of such drugs by the form of Official Letter on Clinical Study of Drugs.
| | 第五十七条 国家药品监督管理局在受理新药申请后，组织药学、医学和其他技术人员，对新药进行技术审评，以《药物临床研究批件》的形式，决定是否批准其进行临床研究。
|
Article 58 If the institute for drug control deems that the drug standard supplied can't control the quality, the applicant may withdraw its application for new drugs. If the application is not withdrawn, the SDA may return such application if it is determined that the drug standard can't control the quality after examination.
| | 第五十八条 药品检验所认为申报的药品标准无法控制质量的，申请人可以撤回新药申请。未撤回的，国家药品监督管理局经审核其药品标准确属无法控制质量的，予以退审。
|
Article 59 If it does not accord with its medicines standard declared that the sample is examined, the SDA may return the drug‘s application after examination.
| | 第五十九条 样品检验不符合其申报的药品标准的，国家药品监督管理局在核实后对该新药申请予以退审。
|
Article 60 If a withdrawn application for new drugs meets the conditions for application after the applicant makes study over again, it may be filed again and be processed pursuant to the original application procedures.
| | 第六十条 撤回的新药申请，申请人在重新进行研究后，符合申请条件的，可以重新提交申请，并按照原申请程序办理。
|
Article 61 During the examination of an application for drug registration by the SDA, no new technical materials may be supplemented except for innovative drug components or new discoveries involving the safety of drugs. If it is a must to supplement new technical materials, the applicant shall withdraw its application for drug registration and file a new one pursuant to the original procedures.
| | 第六十一条 国家药品监督管理局审查药品注册申请期间，除创新的药物成份或者涉及药品安全性的新发现，一般不得补充新的技术资料。必须补充新的技术资料的，申请人应当撤回其药品注册申请，按照原程序重新申报。
|
Section 3 Examination & Approval of Manufacturing of New Drugs
| | 第三节 新药生产的审批
|
Article 62 After finishing the clinical study of drugs, an applicant shall submit the clinical study materials and other modified and supplemented materials to the drug administration of the province, autonomous region or municipality directly under the Central Government where it is located, explain the basis and reasons in details, and send the raw materials of the standard products to the National Institute for the Control of Pharmaceutical and Biological Products at the same time.
．．．．．． | | 第六十二条 完成药物临床研究后，申请人向所在地省、自治区、直辖市药品监督管理局报送临床研究资料及其他变更和补充的资料，并详细说明依据和理由，同时向中国药品生物制品检定所报送制备标准品的原材料。
．．．．．． |
Dear visitor,you are attempting to view a subscription-based section of lawinfochina.com. If you are already a subscriber, please login to enjoy access to our databases . If you are not a subscriber, please subscribe . Should you have any questions, please contact us at:
+86 (10) 8268-9699 or +86 (10) 8266-8266 (ext. 153)
Mobile: +86 133-1157-0713
Fax: +86 (10) 8266-8268
database@chinalawinfo.com
| |
您好：您现在要进入的是北大法律英文网会员专区，如您是我们英文用户可直接 登录，进入会员专区查询您所需要的信息；如您还不是我们 的英文用户，请注册并交纳相应费用成为我们的英文会员 。如有问题请来电咨询；
Tel: +86 (10) 82689699, +86 (10) 82668266 ext. 153
Mobile: +86 13311570713
Fax: +86 (10) 82668268
E-mail: database@chinalawinfo.com
|
| | | |
| | | |