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Provisions for Drug Registration (2007) [Expired]
药品注册管理办法(2007) [失效]
【法宝引证码】
 
  
  
Decree of the China Food and Drug Administration
(No. 28)
The Provisions for Drug Registration, adopted at the Meeting of the China Food and Drug Administration on June 18, 2007, are hereby promulgated and shall be effective as of October 1, 2007.
Officer: Shao Mingli
July 10, 2007
Provisions for Drug Registration
 

国家食品药品监督管理局令
(第28号)


药品注册管理办法》于2007年6月18日经国家食品药品监督管理局局务会审议通过,现予公布,自2007年10月1日起施行。
局长:邵明立
二○○七年七月十日
药品注册管理办法
Chapter I General Provisions
 

第一章 总则


Article 1 The Provisions are formulated for the purposes of ensuring the safety, efficacy and quality of drugs and regulating drug registration in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law), Administrative Permission Law of the People's Republic of China (hereinafter referred to as Administrative Permission Law) and the Regulations for Implementation of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Regulations for Implementation of the Drug Administration Law).
   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》)、《中华人民共和国行政许可法》(以下简称《行政许可法》)、《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 The Provisions apply to the applications for drug clinical trial, drug production or import, and conducting drug approval, relevant testing for drug registration, or regulation thereof, within the territory of the People's Republic of China.
   第二条 在中华人民共和国境内申请药物临床试验、药品生产和药品进口,以及进行药品审批、注册检验和监督管理,适用本办法。
Article 3 Drug registration refers to the process of review and approval on which the State Food and Drug Administration, in accordance with the official procedures, evaluates the safety, efficacy and quality of the drugs applied for marketing, and decides whether or not to approve such an application.
   第三条 药品注册,是指国家食品药品监督管理局根据药品注册申请人的申请,依照法定程序,对拟上市销售药品的安全性、有效性、质量可控性等进行审查,并决定是否同意其申请的审批过程。
Article 4 The State encourages the research and development of new drugs and adopts the special review and approval with respect to innovative drugs, new drugs for serious and life-threatening diseases and to address unmet medical needs and drugs.
   第四条 国家鼓励研究创制新药,对创制的新药、治疗疑难危重疾病的新药实行特殊审批。
Article 5 The State Food and Drug Administration is in charge of drug registration nationwide, and responsible for reviewing and approving the clinical trial, production and importation of drugs.
   第五条 国家食品药品监督管理局主管全国药品注册工作,负责对药物临床试验、药品生产和进口进行审批。
Article 6 The drug registration shall follow the principles of openness, fairness and justice.
The State Food and Drug Administration adopts the system of collective responsibility of the chief reviewers, the system of publicizing and challenging relevant persons, and the system of responsibility tracing, with social supervision in such procedures as acceptance, inspection, review and approval and sending.
   第六条 药品注册工作应当遵循公开、公平、公正的原则。
国家食品药品监督管理局对药品注册实行主审集体负责制、相关人员公示制和回避制、责任追究制,受理、检验、审评、审批、送达等环节接受社会监督。
Article 7 In the process of drug registration, the drug regulatory department shall make known to the general public, and hold hearings on, the matters which it deems of vital importance and involving public interests for the granting of permission.
Prior to making the decision of administrative licensing that has a direct bearing on the vital interest between the applicant and the other party, the drug regulatory department shall inform the applicant and the interested party of their rights of requesting for hearings, making statements and argues.
   第七条 在药品注册过程中,药品监督管理部门认为涉及公共利益的重大许可事项,应当向社会公告,并举行听证。
行政许可直接涉及申请人与他人之间重大利益关系的,药品监督管理部门在作出行政许可决定前,应当告知申请人、利害关系人享有要求听证、陈述和申辩的权利。
Article 8 The drug regulatory department shall provide the applicant with access to information on the status of the acceptance, examination, inspection, review and approval of drug registration application and the final resolution.
The drug regulatory department shall publicize the following information on its official websites or at the official premises for accepting applications:
   第八条 药品监督管理部门应当向申请人提供可查询的药品注册受理、检查、检验、审评、审批的进度和结论等信息。
药品监督管理部门应当在行政机关网站或者注册申请受理场所公开下列信息:
(1) the items, procedures, fees and their basis, and timelines of the drug registration, index of all the data needed to be submitted and model text of the application form;(2) the name list and other relevant information on the persons involved in the acceptance, examination, inspection, review and approval of drug registration; and(3) general information about categories of approved drugs, etc.
 (一)药品注册申请事项、程序、收费标准和依据、时限,需要提交的全部材料目录和申请书示范文本;
Article 9 The drug regulatory department, relevant institutions and persons involved in the drug registration have an obligation to keep the technical secrets and trial data submitted by the applicant confidential.
 (二)药品注册受理、检查、检验、审评、审批各环节人员名单和相关信息;
Chapter II Application for Drug Registration
 (三)已批准的药品目录等综合信息。
Article 10 An applicant for drug registration (hereinafter referred to as applicant) refers to the institution that submits a drug registration application and assumes corresponding legal liability.
A domestic applicant shall be an institution legally registered within the territory of People's Republic of China that independently assumes civil liability and an overseas applicant shall be a legal overseas drug manufacturer. Where an overseas applicant applies for import drug registration, it shall be done by its branch or entrusted agency within the territory of People's Republic of China.
The persons who handle the application for drug registration shall have professional knowledge and be familiar with the laws and regulations on, and the technical requirements for, drug registration.
   第九条 药品监督管理部门、相关单位以及参与药品注册工作的人员,对申请人提交的技术秘密和实验数据负有保密的义务。
Article 11 Drug registration applications include applications for new drugs, generic drugs, import drugs and their supplementary applications as well as re-registration applications.
Applications of domestic applicants shall be handled according to the procedures and requirements for new drugs or generic drugs, whereas applications of overseas applicants shall be handled according to those for import drugs.
 

第二章 基本要求


Article 12 Application for new drugs refers to application for registration of drugs that have not been marketed within the territory of People's Republic of China.
Application for changing dosage form or route of administration, or claiming a new indication for marketed drugs, shall be submitted as the process of new drug application.
Application for generic drugs refers to registration application for producing the drugs having existing national drug standard which is approved to be marketed by the State Food and Drug Administration, whereas the application for biological products shall be submitted as the process of new drug application.
Application for import drugs refers to registration application for drugs manufactured abroad to be marketed within the territory of the People's Republic of China.
Supplementary application refers to application for variation, addition, or cancellation of the items or contents approved in the original application for new drug, generic drug or import drug.
Re-registration application refers to application for continued production or importation of a drug after the expiration of the valid term of the drug approval document.
   第十条 药品注册申请人(以下简称申请人),是指提出药品注册申请并承担相应法律责任的机构。
境内申请人应当是在中国境内合法登记并能独立承担民事责任的机构,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具有相应的专业知识,熟悉药品注册的法律、法规及技术要求。
Article 13 The applicant shall provide sufficient and reliable research data to prove the safety, efficacy and quality of the drug, and be liable for the authenticity of all the dossiers submitted.
   第十一条 药品注册申请包括新药申请、仿制药申请、进口药品申请及其补充申请和再注册申请。
境内申请人申请药品注册按照新药申请、仿制药申请的程序和要求办理,境外申请人申请进口药品注册按照进口药品申请的程序和要求办理。
Article 14 The cited literature of the dossier of drug registration shall indicate the title of works or the name, volume number, issue and page of the journal. Where the cited references are not published, an author's permission shall be provided. For foreign literatures, Chinese translation shall be provided as required.
   第十二条 新药申请,是指未曾在中国境内上市销售的药品的注册申请。
对已上市药品改变剂型、改变给药途径、增加新适应症的药品注册按照新药申请的程序申报。
仿制药申请,是指生产国家食品药品监督管理局已批准上市的已有国家标准的药品的注册申请;但是生物制品按照新药申请的程序申报。
进口药品申请,是指境外生产的药品在中国境内上市销售的注册申请。
补充申请,是指新药申请、仿制药申请或者进口药品申请经批准后,改变、增加或者取消原批准事项或者内容的注册申请。
再注册申请,是指药品批准证明文件有效期满后申请人拟继续生产或者进口该药品的注册申请。
Article 15 The State Food and Drug Administration shall obey the development plan and policies on the pharmaceutical industry constituted by the State, and may conduct assessment to the market value of drugs.
   第十三条 申请人应当提供充分可靠的研究数据,证明药品的安全性、有效性和质量可控性,并对全部资料的真实性负责。
Article 16 In the process of drug registration, the drug regulatory department shall conduct on-site inspection and causal inspection to the non-clinical studies and clinical trials, as well as production site inspection for the pre-marketing approval to confirm the authenticity, precision and integrity of the dossier submitted.
   第十四条 药品注册所报送的资料引用文献应当注明著作名称、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 17 Where two or more institutions jointly apply for drugs, the application shall be submitted to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, in which the drug manufacturer is located; where the applicants are all drug manufacturers, the application shall be submitted to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, in which the manufacturer of pharmaceutical preparations is located; where none of the applicants is a drug manufacturer, the application shall be submitted to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, in which the site for pilot production of drug samples is located.
   第十五条 国家食品药品监督管理局应当执行国家制定的药品行业发展规划和产业政策,可以组织对药品的上市价值进行评估。
Article 18 An applicant shall provide the information on patent and its ownership of the applicant or other parties in China, in respect of the drug applied for registration, its formula, manufacturing processes and/or uses, etc. Where another party owns the patent in China, the applicant shall provide a statement of non-infringement. The drug regulatory department shall publish the information or the statement submitted by the applicant on its official website.
Where a patent dispute occurs in the process of drug registration, it shall be settled in accordance with relevant laws and regulations on patent.
   第十六条 药品注册过程中,药品监督管理部门应当对非临床研究、临床试验进行现场核查、有因核查,以及批准上市前的生产现场检查,以确认申报资料的真实性、准确性和完整性。
Article 19 For a drug patented in China, applicants other than the patentee may submit the application for registration two years prior to the expiry date of the patent. The State Food and Drug Administration shall review the drug application in accordance with the Provisions, and after the expiry date of the patent, check and issue the drug approval number, Import Drug License or a Pharmaceutical Product License if the application conforms with the provisions.
   第十七条 两个以上单位共同作为申请人的,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部门提出申请;申请人均为药品生产企业的,应当向申请生产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部门提出申请;申请人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部门提出申请。
Article 20 In accordance with the provisions in Article 35 of the Regulations for Implementation of the Drug Administration Law, where a manufacturer or distributor submits undisclosed drug experimental and other data which are independently acquired in order to obtain approval for production or marketing of the drug in question which contains any new chemical entity, the State Food and Drug Administration shall, within six years from the approval date of the drug, reject any application made by any other applicants by using the undisclosed data of the drug in question without permission of the original applicant who has obtained the drug approval, unless the data submitted are independently acquired by the applicants other than the original one.
   第十八条 申请人应当对其申请注册的药物或者使用的处方、工艺、用途等,提供申请人或者他人在中国的专利及其权属状态的说明;他人在中国存在专利的,申请人应当提交对他人的专利不构成侵权的声明。对申请人提交的说明或者声明,药品监督管理部门应当在行政机关网站予以公示。
药品注册过程中发生专利权纠纷的,按照有关专利的法律法规解决。
Article 21 Pre-clinical drug study for drug registration application includes drug synthetic processes, extraction methods, physical and chemical properties, purity, selection of dosage form, screening of formula, preparing processes, testing methods, quality specifications, stability, pharmacology, toxicology and animal pharmacokinetics, etc. For traditional Chinese medicine preparations, in addition to the above-mentioned items, pre-clinical drug study also includes the study in the source of the crude drugs, and of their pre-treatment and processing, etc. For biological products, it also includes study on the source, quality specifications, storage conditions, biological characteristics and genetic stability of the starting materials such as bacterial and viral seeds/strains, cell lines, bio-tissues, and immunological study, etc.
   第十九条 对他人已获得中国专利权的药品,申请人可以在该药品专利期届满前2年内提出注册申请。国家食品药品监督管理局按照本办法予以审查,符合规定的,在专利期满后核发药品批准文号、《进口药品注册证》或者《医药产品注册证》。
Article 22 A pre-clinical drug study shall be in conformity with relevant requirements, among which the Good Laboratory Practice for Non-Clinical Laboratory Studies shall be implemented in the study of safety evaluation.
   第二十条 按照《药品管理法实施条例》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,国家食品药品监督管理局自批准该许可之日起6年内,对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;但是申请人提交自行取得数据的除外。
Article 23 The drug research institution shall have relevant staff, premises, equipment, instruments and management system, which are appropriate to the research project, and ensure the authenticity of all experimental data. Experimental animals, reagents and raw materials used in the study shall conform with the provisions of the State.
   第二十一条 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、动物药代动力学研究等。中药制剂还包括原药材的来源、加工及炮制等的研究;生物制品还包括菌毒种、细胞株、生物组织等起始原材料的来源、质量标准、保存条件、生物学特征、遗传稳定性及免疫学的研究等。
Article 24 An applicant who entrusts other institutions with a drug research, individual experiment, testing, or pilot production, etc. shall conclude a contract with the trustee, and state it clearly in the registration application. The applicant shall be responsible for the authenticity of the research data in the application dossier.
   第二十二条 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 25 Where the application is only for registration of pharmaceutical preparations, any drug substance used for the study shall have a drug approval number, an Import Drug License or a Pharmaceutical Product License, and be acquired through legitimated means. Where a drug substance used for the study has no drug approval number, Import Drug License or Pharmaceutical Product License, the use of drug substance in study shall be approved by the State Food and Drug Administration.
   第二十三条 药物研究机构应当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,并保证所有试验数据和资料的真实性;所用实验动物、试剂和原材料应当符合国家有关规定和要求。
Article 26 The research data in application dossier for drug registration provided by an overseas drug research institution shall be attached with the items and pages of the information, and with notarized documents proving that the said drug research institution is legally registered overseas. The State Food and Drug Administration may send staff to conduct on-site inspection in needs of drug review.
   第二十四条 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、样品的试制等的,应当与被委托方签订合同,并在申请注册时予以说明。申请人对申报资料中的药物研究数据的真实性负责。
Article 27 The drug regulatory department may request the applicant or the drug research institution responsible for testing to repeat the test based on the items, methods and data specified in the application documents, and may also authorize a drug testing institute or another drug research institution to repeat the test or conduct methodological verification.
   第二十五条 单独申请注册药物制剂的,研究用原料药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》,且必须通过合法的途径获得。研究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,必须经国家食品药品监督管理局批准。
Article 28 The drug study shall be conducted according to the relevant technical guidelines issued by the State Food and Drug Administration. Where an applicant conducts the study by adopting other evaluation methods and techniques, supporting data proving the scientific feasibility of such methods and techniques shall be provided.
   第二十六条 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的经公证的证明文件。国家食品药品监督管理局根据审查需要组织进行现场核查。
Article 29 An applicant who obtains the drug approval number shall manufacture according to the manufacturing processes approved by the State Food and Drug Administration.
The drug regulatory department shall supervise and inspect the applicant's manufacture in accordance with the approved manufacturing processes and quality specifications.
   第二十七条 药品监督管理部门可以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,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或方法学验证。
Chapter III Drug Clinical Trials
   第二十八条 药物研究参照国家食品药品监督管理局发布的有关技术指导原则进行,申请人采用其他评价方法和技术的,应当提交证明其科学性的资料。
Article 30 Any drug clinical trial, including bioequivalence study, shall be approved by the State Food and Drug Administration, and shall be in compliance with the Good Clinical Practice.
Drug regulatory department shall supervise and inspect the approved clinical trials.
   第二十九条 申请人获得药品批准文号后,应当按照国家食品药品监督管理局批准的生产工艺生产。
药品监督管理部门根据批准的生产工艺和质量标准对申请人的生产情况进行监督检查。
Article 31 Clinical trials shall be conducted for new drug registration applications. As for generic drug registration applications and supplementary applications, clinical trials shall be conducted in accordance with the requirements in the Annex of the Provisions.
A clinical trial consists of phases I, II, III and IV.
Phase I Clinical Trial: initial clinical pharmacology and safety evaluation studies in humans. These studies are designed to observe tolerability of humans to and pharmacokinetics of a new drug, in order to provide basis for establishing the administration regimen.
Phase II Clinical Trial: preliminary evaluation of therapeutic effectiveness of a drug. The purposes are to preliminarily evaluate the therapeutic effectiveness and safety of the drug for particular indication(s) in patients, and provide evidence for design of Phase III clinical trial and settlement of administrative dose regimen. According to specific trial objectives, this phase of trial may be designed in various forms, including the randomized blind controlled clinical trial.
Phase III Clinical Trial: confirmation of therapeutic effectiveness of a drug. The purposes are to further verify drug therapeutic effectiveness and safety on eligible patients with target indication(s), to evaluate overall benefit-risk relationships of the drug, and to ultimately provide sufficient evidence for the review of drug registration application. The study, in general, shall be a randomized blind controlled trial with an adequate sample size.
Phase IV Clinical Trial: a new drug post-marketing study. The purposes are to assess therapeutic effectiveness and adverse reactions when a drug is widely used, to evaluate overall benefit-risk relationships of the drug when used among general population or specific groups, and to adjust the administration dose, etc.
Bioequivalence study refers to a human study, which applies bioavailability study methods with pharmacokinetic parameters as indicators to compare active ingredient absorption rate and extent of the preparations in the same or different dosage forms of a drug in terms of statistical differences under the same experimental condition.
 

第三章 药物的临床试验


Article 32 The sample size of a drug clinical trial shall conform to the objectives of the clinical trial and fulfill statistical requirements, and shall be no smaller than the minimum number of subjects required by the Annex of the Provisions. Where there are circumstances, regarding rare or special diseases, etc., which request clinical sample size reduction or clinical trial exemption, a request shall be made with the clinical trial application, and reviewed and approved by the State Food and Drug Administration.
   第三十条 药物的临床试验(包括生物等效性试验),必须经过国家食品药品监督管理局批准,且必须执行《药物临床试验质量管理规范》。
药品监督管理部门应当对批准的临床试验进行监督检查。
Article 33 As for vaccines prepared during bacterial or viral strain screening or other special drugs, if confirmed without any suitable animal model and laboratory measurement in terms of curative effectiveness, clinical trials may be applied for to the State Food and Drug Administration, subject to ensuring the safety of trial subjects.
   第三十一条 申请新药注册,应当进行临床试验。仿制药申请和补充申请,根据本办法附件规定进行临床试验。
临床试验分为I、II、Ⅲ、IV期。
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的审查提供充分的依据。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以及改进给药剂量等。
生物等效性试验,是指用生物利用度研究的方法,以药代动力学参数为指标,比较同一种药物的相同或者不同剂型的制剂,在相同的试验条件下,其活性成份吸收程度和速度有无统计学差异的人体试验。
Article 34 When a drug clinical trial is approved, the applicant shall select institutions for the clinical trial from those certified for conducting drug clinical trials.
   第三十二条 药物临床试验的受试例数应当符合临床试验的目的和相关统计学的要求,并且不得少于本办法附件规定的最低临床试验病例数。罕见病、特殊病种等情况,要求减少临床试验病例数或者免做临床试验的,应当在申请临床试验时提出,并经国家食品药品监督管理局审查批准。
Article 35 Drugs used for clinical trials shall be manufactured in facilities in compliance with the Good Manufacturing Practice for Pharmaceutical Products (GMP). The manufacturing process shall strictly meet the requirements of the GMP.
The applicant shall be responsible for the quality of the drugs used for clinical trials.
   第三十三条 在菌毒种选种阶段制备的疫苗或者其他特殊药物,确无合适的动物模型且实验室无法评价其疗效的,在保证受试者安全的前提下,可以向国家食品药品监督管理局申请进行临床试验。
Article 36 The applicant may conduct the testing for clinical trial drugs by itself, or entrust a drug testing institute specified in the Provisions to conduct such testing, according to its proposed specifications. Vaccines, blood products and other biological products specified by the State Food and Drug Administration shall be tested by drug testing institutes designated by the State Food and Drug Administration.
A drug can be used for a clinical trial only after tested as qualified.
Drug regulatory departments may conduct sampling and testing on drugs used for clinical trials.
   第三十四条 药物临床试验批准后,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。
Article 37 Prior to conducting a clinical trial, the applicant shall report to the State Food and Drug Administration for record while copying to the drug regulatory department of the seat of the clinical trial institution and that of the province, autonomous region or municipality directly under the Central Government to receive the application a confirmed clinical trial protocol, the name of the principal investigator at the institution in charge of the clinical trial, a list of participating institutions and names of investigators wherefrom, an ethic committee approval letter, and a template of the informed consent form, etc.
   第三十五条 临床试验用药物应当在符合《药品生产质量管理规范》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。
申请人对临床试验用药物的质量负责。
Article 38 Where the applicant finds a clinical trial institution violating relevant regulations or failing to implement the clinical trial protocol, it shall urge the institution to make corrections; if the circumstances are serious, the applicant may demand suspension or termination of the clinical trial, and shall report the matter to the State Food and Drug Administration and the drug regulatory departments of the relevant provinces, autonomous regions or municipalities directly under the Central Government.
   第三十六条 申请人可以按照其拟定的临床试验用样品标准自行检验临床试验用药物,也可以委托本办法确定的药品检验所进行检验;疫苗类制品、血液制品、国家食品药品监督管理局规定的其他生物制品,应当由国家食品药品监督管理局指定的药品检验所进行检验。
临床试验用药物检验合格后方可用于临床试验。
药品监督管理部门可以对临床试验用药物抽查检验。
Article 39 After completion of a clinical trial, the applicant shall submit a clinical trial final report, a statistical analysis report and its database to the State Food and Drug Administration.
   第三十七条 申请人在药物临床试验实施前,应当将已确定的临床试验方案和临床试验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食品药品监督管理局备案,并抄送临床试验单位所在地和受理该申请的省、自治区、直辖市药品监督管理部门。
Article 40 A clinical trial shall be conducted within three years after approval. If overdue, the original approval documents shall be invalid. If the clinical trial is still needed, the application shall be reapplied for.
   第三十八条 申请人发现药物临床试验机构违反有关规定或者未按照临床试验方案执行的,应当督促其改正;情节严重的,可以要求暂停或者终止临床试验,并将情况报告国家食品药品监督管理局和有关省、自治区、直辖市药品监督管理部门。
Article 41 If any serious adverse event occurs during the clinical trial, the investigators shall report to the drug regulatory departments of the relevant provinces, autonomous regions or municipalities directly under the Central Government and the State Food and Drug Administration and notify the applicant within 24 hours, and report to the ethic committee in time.
   第三十九条 申请人完成临床试验后,应当向国家食品药品监督管理局提交临床试验总结报告、统计分析报告以及数据库。
Article 42 In any of the following circumstances during a clinical trial, the State Food and Drug Administration may order the applicant to modify the protocol, suspend or terminate the clinical trial,:
   第四十条 药物临床试验应当在批准后3年内实施。逾期未实施的,原批准证明文件自行废止;仍需进行临床试验的,应当重新申请。
(1) the ethic committee fails to perform its duty;(2) safety of the subjects cannot be adequately ensured;(3) a serious adverse event is not reported within the specified timeline;(4) there is evidence to prove that the drug used for the clinical trial is not effective;(5) a quality problem of the drug used for the clinical trial occurs;(6) there is a fraud in the clinical trial; or(7) there is any other case violating the Good Clinical Practice.
   第四十一条 临床试验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部门和国家食品药品监督管理局,通知申请人,并及时向伦理委员会报告。
Article 43 Where there is any large-scale of and unexpected adverse reaction or serious adverse event, or there is evidence to prove any serious quality problem of the drug used for a clinical trial, the State Food and Drug Administration or the drug regulatory department of the province, autonomous region or municipality directly under the Central Government may take emergency control measures and order to suspend or terminate the clinical trial. The applicant and clinical trial institution must stop the clinical trial immediately.
   第四十二条 临床试验有下列情形之一的,国家食品药品监督管理局可以责令申请人修改试验方案、暂停或者终止临床试验:
Article 44 An overseas applicant intending to conduct an international multi-center clinical trial in China shall submit an application to the State Food and Drug Administration in accordance with the Provisions, and fulfill the following requirements:
 (一)伦理委员会未履行职责的;
(1) the drugs used for clinical trials shall be already approved or in phase II or III clinical trial overseas. The State Food and Drug Administration does not accept any overseas applicant's international multi-center clinical trial application for any preventive vaccine not being registered overseas yet;(2) while approving to conduct an international multi-center clinical trial, the State Food and Drug Administration may require the applicant to conduct phase I clinical trial first in China;(3) when conducting an international multi-center clinical trial in China, if there are any observed serious adverse reaction and unexpected adverse reaction associated with the drug in any country, the applicant shall, in accordance with relevant regulations, report to the State Food and Drug Administration in time;(4) the applicant shall submit a complete clinical trial report to the State Food and Drug Administration after the completion of a clinical trial; and(5) the data obtained from an international multi-center clinical trial for drug registration application in China shall be in conformity with the requirements on clinical trial in the Provisions. All the study materials of the international multi-center clinical trial shall be submitted.
 (二)不能有效保证受试者安全的;
Chapter IV Application and Approval of New Drugs
 (三)未按照规定时限报告严重不良事件的;
Article 45 The State Food and Drug Administration may implement special review and approval in cases of the following applications:
 (四)有证据证明临床试验用药物无效的;
(1) active ingredients extracted from plants, animals and minerals, etc. and their preparations not yet marketed in China, and newly discovered Chinese crude drugs and their preparations;(2) chemical drug substances and their preparations and biological products not yet approved for marketing in China or abroad;(3) new drugs for the treatment of diseases such as AIDS, malignant tumors and rare diseases, etc. with significant clinical advantage; and(4) new drugs for the treatment of diseases, for which effective therapeutic methods are not available.
For drugs specified in the previous clause, applicants may apply for special review and approval in the process of drug registration. The Center for Drug Evaluation of the State Food and Drug Administration shall organize expert meetings to discuss and determine whether or not to conduct special review and approval for the drugs.
Specified measures for special review and approval shall be formulated separately.
 (五)临床试验用药物出现质量问题的;
Article 46 Where a new drug is co-developed by several institutions, the registration can be applied for by one of the institutions, and its duplicate application shall not be made by the others. If a joint application for registration is needed, the institutions shall co-sign as the applicant of the new drug. Each approved new drug, including its different strengths shall be produced by only one institution.
 (六)临床试验中弄虚作假的;
Article 47 For the registration application to change the dosage form without changing administration route of a marketed drug, new techniques shall be employed to improve the drug quality and safety, and the changed dosage form shall have significant clinical advantage compared with the previous dosage form.
Registration applications to change the dosage form without changing the route of administration or to claim any new indication shall be submitted by certified manufacturers, with exceptions for special dosage forms such as targeting delivery, sustained release and controlled release preparations, etc.
 (七)其他违反《药物临床试验质量管理规范》的情形。
Article 48 In the process of the review and approval of a new drug, the registration classification and technical requirements thereof shall not be changed, even though the preparations of the same active ingredients are approved for marketing abroad.
In the process of the review and approval of a new drug, the registration classification and technical requirements thereof shall not be changed, even though the preparations of the same active ingredients applied for by domestic manufacturers are approved for marketing in China.
   第四十三条 临床试验中出现大范围、非预期的不良反应或者严重不良事件,或者有证据证明临床试验用药物存在严重质量问题时,国家食品药品监督管理局或者省、自治区、直辖市药品监督管理部门可以采取紧急控制措施,责令暂停或者终止临床试验,申请人和临床试验单位必须立即停止临床试验。
Article 49 The dossier for drug registration application shall be submitted at one time. No other technical materials should be added by the applicant after a drug registration application is accepted, with the exceptions for applications of special review and approval, new finding regarding drug safety, or supplementary materials as required. Where an applicant deems it integrant for any new technical material to be supplemented, the submitted application shall be withdrawn. Only if no same product is in the new drug observation period, the applicant may re-apply in compliance with the relevant requirements in the Provisions.
   第四十四条 境外申请人在中国进行国际多中心药物临床试验的,应当按照本办法向国家食品药品监督管理局提出申请,并按下列要求办理:
Section 1 Clinical Trials for New Drugs
 (一)临床试验用药物应当是已在境外注册的药品或者已进入II期或者Ⅲ期临床试验的药物;国家食品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药物的国际多中心药物临床试验申请;
Article 50 After completing the pre-clinical study, the applicant shall fill the Application Form for Drug Registration, and report authentically relevant materials to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the applicant is located.
 (二)国家食品药品监督管理局在批准进行国际多中心药物临床试验的同时,可以要求申请人在中国首先进行I期临床试验;
Article 51 Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall conduct the preliminary review of the application dossiers, and issue a acceptance notice of drug registration application if requirements are met, or issue a non-acceptance notice, in which reasons shall be given, of drug registration application if requirements are not met.
 (三)在中国进行国际多中心药物临床试验时,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食品药品监督管理局;
Article 52 Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall organize to conduct on-site inspections of the drug research and development conditions and raw data, make preliminary review of the submitted dossiers, and provide review opinions within five days from the date it accepts an application. Where the drug for which the registration is applied is a biological product, samples from three production batches thereof shall also be collected for testing, and a notice for the testing for registration shall be issued to the drug testing institute.
 (四)临床试验结束后,申请人应当将完整的临床试验报告报送国家食品药品监督管理局;
Article 53 Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall deliver the review opinions, inspection reports and the application dossiers to the Center for Drug Evaluation of the State Food and Drug Administration within the specified timeline, and notice the applicants.
 (五)国际多中心药物临床试验取得的数据用于在中国进行药品注册申请的,应当符合本办法有关临床试验的规定并提交国际多中心临床试验的全部研究资料。
Article 54 The drug testing institute that receives a notice for the testing for registration shall test the samples according to the drug specifications submitted by the applicant, verify the submitted drug specifications, and submit a certificate of analysis for drug registration to the Center for Drug Evaluation of the State Food and Drug Administration within the specified timeline, and copy to the applicant.
 

第四章 新药申请的申报与审批


Article 55 After receiving submitted dossiers, the Center for Drug Evaluation of the State Food and Drug Administration shall organize pharmaceutical, medical and other technical personnel to conduct technical review of the submitted dossiers within the specified timeline, and may request, with reasons, applicants to provide supplementary materials when necessary. After completing technical reviews, the Center for Drug Evaluation shall give technical review opinions and report together with relevant documents to the State Food and Drug Administration.
The State Food and Drug Administration shall make review and approval decisions based on the technical review opinions. Where the regulations are conformed to, a Drug Clinical Trial Approval shall be issued; where the regulations are not conformed to, a Disapproval Notice shall be issued with reasons provided.
   第四十五条 国家食品药品监督管理局对下列申请可以实行特殊审批:
Section 2 Production of New Drugs
 (一)未在国内上市销售的从植物、动物、矿物等物质中提取的有效成份及其制剂,新发现的药材及其制剂;
Article 56 After completing drug clinical trials, applicants shall fill the Application Form for Drug Registration, submit production application dossiers to the drug regulatory departments of the provinces, autonomous regions, or municipalities directly under the Central Government where the applicant is located, and at the same time provide the raw materials and research information for preparing reference standards to the National Institute for the Control of Pharmaceutical and Biological Products.
 (二)未在国内外获准上市的化学原料药及其制剂、生物制品;
Article 57 Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall conduct the preliminary review of the application dossiers, and issue an acceptance notice of drug registration application if requirements are met, or issue a non-acceptance notice, in which reasons shall be given, of drug registration application if requirements are not met.
 (三)治疗艾滋病、恶性肿瘤、罕见病等疾病且具有明显临床治疗优势的新药;
Article 58 Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall organize to conduct on-site inspections of the drug research and development conditions and raw data, make preliminary review of the submitted dossiers, and provide review opinions within five days from the date it accepts an application. For the other drugs except biological products, samples of three production batches shall also be collected for testing, and a notice of specifications verification shall be issued to the drug testing institute.
Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall deliver the review opinions, inspection reports and the application dossiers to the Center for Drug Evaluation of the State Food and Drug Administration within the specified timeline, and notice the applicants.
 (四)治疗尚无有效治疗手段的疾病的新药。
符合前款规定的药品,申请人在药品注册过程中可以提出特殊审批的申请,由国家食品药品监督管理局药品审评中心组织专家会议讨论确定是否实行特殊审批。
特殊审批的具体办法另行制定。
Article 59 Drug testing institutes shall verify the submitted drug specifications and give the verification opinions to the Center for Drug Evaluation of the State Food and Drug Administration within the specified timeline, and at the same time copy to the drug regulatory departments of the provinces, autonomous regions, or municipalities directly under the Central Government that notify them to conduct the verification, and the applicants.
   第四十六条 多个单位联合研制的新药,应当由其中的一个单位申请注册,其他单位不得重复申请;需要联合申请的,应当共同署名作为该新药的申请人。新药申请获得批准后每个品种,包括同一品种的不同规格,只能由一个单位生产。
Article 60 After receiving submitted dossiers, the Center for Drug Evaluation of the State Food and Drug Administration shall organize pharmaceutical, medical and other technical personnel to conduct technical review of the submitted dossiers within the specified timeline, and may request, with reasons, applicants to provide supplementary materials when necessary.
Where the regulations are conformed to as reviewed, the Center for Drug Evaluation of the State Food and Drug Administration shall notice the applicant to apply for production site inspection and inform the Center for Drug Certification of the State Food and Drug Administration. Where the regulations are not conformed to as reviewed, the Center for Drug Evaluation of the State Food and Drug Administration shall report the review opinions and relevant documents to the State Food and Drug Administration; the State Food and Drug Administration shall make a disapproval decision to the application based on the technical review opinions, and issue a Disapproval Notice with reasons.
   第四十七条 对已上市药品改变剂型但不改变给药途径的注册申请,应当采用新技术以提高药品的质量和安全性,且与原剂型比较有明显的临床应用优势。
改变剂型但不改变给药途径,以及增加新适应症的注册申请,应当由具备生产条件的企业提出;靶向制剂、缓释、控释制剂等特殊剂型除外。
Article 61 The applicant shall apply for on-site inspection to the Center for Drug Certification of the State Food and Drug Administration within six months from the date it receives the notice of production site inspection.
   第四十八条 在新药审批期间,新药的注册分类和技术要求不因相同活性成份的制剂在国外获准上市而发生变化。
在新药审批期间,其注册分类和技术要求不因国内药品生产企业申报的相同活性成份的制剂在我国获准上市而发生变化。
Article 62 The Center for Drug Certification of the State Food and Drug Administration shall, within 30 days from the date it receives the application for production site inspection, organize on-site inspection of large-scale samples production, verify the applicability of the manufacturing processes and at the same time take samples of one batch of products (samples of three batches of products for biological products), and provide production site inspection report to the Center for Drug Evaluation of the State Food and Drug Administration within ten days after the site inspection.
   第四十九条 药品注册申报资料应当一次性提交,药品注册申请受理后不得自行补充新的技术资料;进入特殊审批程序的注册申请或者涉及药品安全性的新发现,以及按要求补充资料的除外。申请人认为必须补充新的技术资料的,应当撤回其药品注册申请。申请人重新申报的,应当符合本办法有关规定且尚无同品种进入新药监测期。
Article 63 Samples shall be produced at a plant with the GMP Certificate. As for a new manufacturer, a new workshop established or the production of a dosage form added at an existing manufacturer, the sample production shall meet the GMP requirements.
 

第一节 新药临床试验


Article 64 Drug testing institutes shall conduct sample testing according to the verified specifications, and within the specified timeline, provide testing reports to the Center for Drug Evaluation of the State Food and Drug Administration, and copy to the relevant drug regulatory departments of the provinces, autonomous regions, or municipalities directly under the Central Government and the applicants.
   第五十条 申请人完成临床前研究后,应当填写《药品注册申请表》,向所在地省、自治区、直辖市药品监督管理部门如实报送有关资料。
Article 65 The Center for Drug Evaluation of the State Food and Drug Administration shall make a general opinion based on the technical review opinions, production site inspection reports and sample testing results, and report the general opinion together with relevant documents to the State Food and Drug Administration. The State Food and Drug Administration shall make a review and approval decision based on the general opinion. Where the regulations are conformed to, a New Drug Certificate shall be issued; if the applicant already has a Drug Manufacturing Certificate and possesses the production conditions, a drug approval number shall be issued at the same time; where the regulations are not conformed to, a Disapproval Notice shall be issued with reasons.
A New Drug Certificate shall not be issued to the approved registration applications for changing dosage forms without changing route of administration or claiming for new indications, with exceptions for special dosage forms such as targeting delivery, sustained release and controlled release preparations, etc.
   第五十一条 省、自治区、直辖市药品监督管理部门应当对申报资料进行形式审查,符合要求的,出具药品注册申请受理通知书;不符合要求的,出具药品注册申请不予受理通知书,并说明理由。
Section 3 New Drug Observation Period
   第五十二条 省、自治区、直辖市药品监督管理部门应当自受理申请之日起5日内组织对药物研制情况及原始资料进行现场核查,对申报资料进行初步审查,提出审查意见。申请注册的药品属于生物制品的,还需抽取3个生产批号的检验用样品,并向药品检验所发出注册检验通知。
Article 66 In order to protect the public health, the State Food and Drug Administration may set an observation period for any new drug approved for production. The observation period of a new drug shall be no longer than five years from the date the drug is approved for production.
During the observation period of a new drug, the State Food and Drug Administration shall not approve other manufacturers to produce, change dosage form of or import the drug.
   第五十三条 省、自治区、直辖市药品监督管理部门应当在规定的时限内将审查意见、核查报告以及申报资料送交国家食品药品监督管理局药品审评中心,并通知申请人。
Article 67 A drug manufacturer shall investigate the manufacturing processes, quality, stability, therapeutic effect and adverse reactions, etc. of a new drug in the observation period, and report annually to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, where it is located. Where a drug manufacturer fails to perform its duties in the observation period, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall order it to make rectifications.
   第五十四条 接到注册检验通知的药品检验所应当按申请人申报的药品标准对样品进行检验,对申报的药品标准进行复核,并在规定的时间内将药品注册检验报告送交国家食品药品监督管理局药品审评中心,并抄送申请人。
Article 68 Where institutions for drug manufacturing, distribution, use, testing or supervision find any critical quality problem, serious or unexpected adverse reaction of a new drug, they shall report to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government in time. Once receiving the report, the drug regulatory department of a province, autonomous region, or municipality directly under the Central Government shall organize prompt investigation, and report to the State Food and Drug Administration.
   第五十五条 国家食品药品监督管理局药品审评中心收到申报资料后,应在规定的时间内组织药学、医学及其他技术人员对申报资料进行技术审评,必要时可以要求申请人补充资料,并说明理由。完成技术审评后,提出技术审评意见,连同有关资料报送国家食品药品监督管理局。
国家食品药品监督管理局依据技术审评意见作出审批决定。符合规定的,发给《药物临床试验批件》;不符合规定的,发给《审批意见通知件》,并说明理由。
Article 69 Where a drug manufacturer does not conduct production of the new drug, for which an observation period is set, within two years from the date of the approval, the State Food and Drug Administration may approve the application of another drug manufacturer to produce the new drug and reset the observation period of the drug.
 

第二节 新药生产


Article 70 Starting from the date a new drug enters the observation period, any other application for the clinical trial of the same drug already approved by the State Food and Drug Administration may proceed along drug registration application, review and approval procedures; where regulations are conformed to, the State Food and Drug Administration shall approve the production or importation of the same drug. The observations of the drugs produced by the domestic manufacturers should be conducted together with the drug already in the observation period.
   第五十六条 申请人完成药物临床试验后,应当填写《药品注册申请表》,向所在地省、自治区、直辖市药品监督管理部门报送申请生产的申报资料,并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及有关标准物质的研究资料。
Article 71 Starting from the date a new drug enters the observation period, other registration applications for the same drug shall no longer be accepted. The other applicants' applications for the same drug already accepted but not yet approved for clinical trials shall be returned; upon the expiration of the observation period of the drug, the registration of a generic or import drug may be applied for.
   第五十七条 省、自治区、直辖市药品监督管理部门应当对申报资料进行形式审查,符合要求的,出具药品注册申请受理通知书;不符合要求的,出具药品注册申请不予受理通知书,并说明理由。
Article 72 Where an application for an import drug registration is approved first, the domestic application already approved for clinical trial of the drug may proceed along drug registration application, review and approval procedures; where regulations are conformed to, the State Food and Drug Administration shall approve the production of the drug; or, the applicant may withdraw the application, and submit a generic drug application. The other applications for the same drugs already accepted but not yet approved for clinical trials shall be returned; the registration of a generic drug may be applied for.
   第五十八条 省、自治区、直辖市药品监督管理部门应当自受理申请之日起5日内组织对临床试验情况及有关原始资料进行现场核查,对申报资料进行初步审查,提出审查意见。除生物制品外的其他药品,还需抽取3批样品,向药品检验所发出标准复核的通知。
省、自治区、直辖市药品监督管理部门应当在规定的时限内将审查意见、核查报告及申报资料送交国家食品药品监督管理局药品审评中心,并通知申请人。
Chapter V Application and Approval of Generic Drugs
   第五十九条 药品检验所应对申报的药品标准进行复核,并在规定的时间内将复核意见送交国家食品药品监督管理局药品审评中心,同时抄送通知其复核的省、自治区、直辖市药品监督管理部门和申请人。
Article 73 The applicant applying for registration of a generic drug shall be a drug manufacturer. The applied drug shall be within the production scope specified in the Drug Manufacturing Certificate.
   第六十条 国家食品药品监督管理局药品审评中心收到申报资料后,应当在规定的时间内组织药学、医学及其他技术人员对申报资料进行审评,必要时可以要求申请人补充资料,并说明理由。
经审评符合规定的,国家食品药品监督管理局药品审评中心通知申请人申请生产现场检查,并告知国家食品药品监督管理局药品认证管理中心;经审评不符合规定的,国家食品药品监督管理局药品审评中心将审评意见和有关资料报送国家食品药品监督管理局,国家食品药品监督管理局依据技术审评意见,作出不予批准的决定,发给《审批意见通知件》,并说明理由。
Article 74 The generic drug shall have the identical active ingredients, route of administration, dosage form, strength and therapeutic effects with the registered drug. Where a drug has been produced by more than one manufacturer, the selection of registered drugs for comparative study shall be in accordance with relevant technical guidelines.
   第六十一条 申请人应当自收到生产现场检查通知之日起6个月内向国家食品药品监督管理局药品认证管理中心提出现场检查的申请。
Article 75 To apply for the registration of a generic drug, the applicant shall fill the Application Form for Drug Registration, submit relevant dossiers and apply for production site inspection to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located.
   第六十二条 国家食品药品监督管理局药品认证管理中心在收到生产现场检查的申请后,应当在30日内组织对样品批量生产过程等进行现场检查,确认核定的生产工艺的可行性,同时抽取1批样品(生物制品抽取3批样品),送进行该药品标准复核的药品检验所检验,并在完成现场检查后10日内将生产现场检查报告送交国家食品药品监督管理局药品审评中心。
Article 76 Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall conduct the preliminary review of the application dossiers, and issue an acceptance notice of drug registration application if requirements are met, or issue a non-acceptance notice, in which reasons shall be given, of drug registration application if requirements are not met.
As for a drug for which the protection of traditional Chinese medicine preparations has been applied, from the date the application for the protection is accepted through the date an administrative decision is made, the acceptance of the application of its generic drug shall be suspended.
   第六十三条 样品应当在取得《药品生产质量管理规范》认证证书的车间生产;新开办药品生产企业、药品生产企业新建药品生产车间或者新增生产剂型的,其样品生产过程应当符合《药品生产质量管理规范》的要求。
Article 77 Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall organize to conduct on-site inspections of the drug research and development conditions as well as raw data, and production site inspections according to the manufacturing processes and quality specifications provided by the applicant, and take samples of three consecutive batches of products, and send to the drug testing institutes for testing within five days starting from the date they accept an application.
The production of samples shall be in conformity with the requirements in Article 63 in the Provisions.
   第六十四条 药品检验所应当依据核定的药品标准对抽取的样品进行检验,并在规定的时间内将药品注册检验报告送交国家食品药品监督管理局药品审评中心,同时抄送相关省、自治区、直辖市药品监督管理部门和申请人。
Article 78 Drug regulatory departments of the provinces, autonomous regions, or municipalities directly under the Central Government shall review the submitted dossiers within the specified timeline and give review opinions. Where the regulations are conformed to, they shall provide for the Center for Drug Evaluation of the State Food and Drug Administration with the review opinions, the check report, the production site inspection report and the application dossiers, and inform the applicant. Where the regulations are not conformed to, they shall issue a Disapproval Notice with reasons, and notify the drug testing institute to terminate the testing for registration.
   第六十五条 国家食品药品监督管理局药品审评中心依据技术审评意见、样品生产现场检查报告和样品检验结果,形成综合意见,连同有关资料报送国家食品药品监督管理局。国家食品药品监督管理局依据综合意见,作出审批决定。符合规定的,发给新药证书,申请人已持有《药品生产许可证》并具备生产条件的,同时发给药品批准文号;不符合规定的,发给《审批意见通知件》,并说明理由。
改变剂型但不改变给药途径,以及增加新适应症的注册申请获得批准后不发给新药证书;靶向制剂、缓释、控释制剂等特殊剂型除外。
Article 79 Drug testing institutes shall conduct sample testing, provide testing reports to the Center for Drug Evaluation of the State Food and Drug Administration within the specified timeline, and copy to the drug regulatory departments of the provinces, autonomous regions, or municipalities directly under the Central Government that notify them to conduct the verification, and the applicants.
 

第三节 新药监测期


Article 80 The Center for Drug Evaluation of the State Food and Drug Administration shall organize pharmaceutical, medical and other technical personnel to conduct technical review of the submitted dossiers within the specified timeline, and may request, with reasons, applicants to provide supplementary materials when necessary.
   第六十六条 国家食品药品监督管理局根据保护公众健康的要求,可以对批准生产的新药品种设立监测期。监测期自新药批准生产之日起计算,最长不得超过5年。
监测期内的新药,国家食品药品监督管理局不批准其他企业生产、改变剂型和进口。
Article 81 The Center for Drug Evaluation of the State Food and Drug Administration shall make a general opinion based on the technical review opinions, production site inspection reports and sample testing results, and report the general opinion together with relevant documents to the State Food and Drug Administration. The State Food and Drug Administration shall make a review and approval decision based on the general opinion. Where the regulations are conformed to, it shall issue a drug approval number or a Drug Clinical Trial Approval; where the regulations are not conformed to, it shall issue a Disapproval Notice with reasons.
   第六十七条 药品生产企业应当考察处于监测期内的新药的生产工艺、质量、稳定性、疗效及不良反应等情况,并每年向所在地省、自治区、直辖市药品监督管理部门报告。药品生产企业未履行监测期责任的,省、自治区、直辖市药品监督管理部门应当责令其改正。
Article 82 After completing drug clinical trials, applicants shall submit clinical trial data to the Center for Drug Evaluation of the State Food and Drug Administration. The State Food and Drug Administration shall issue a drug approval number or a Disapproval Notice based on the technical review opinions.
   第六十八条 药品生产、经营、使用及检验、监督单位发现新药存在严重质量问题、严重或者非预期的不良反应时,应当及时向省、自治区、直辖市药品监督管理部门报告。省、自治区、直辖市药品监督管理部门收到报告后应当立即组织调查,并报告国家食品药品监督管理局。
Article 83 As for a marketed drug with confirmed safety problems, the State Food and Drug Administration may decide to suspend the acceptance or review and approval of the application of its generic drugs.
   第六十九条 药品生产企业对设立监测期的新药从获准生产之日起2年内未组织生产的,国家食品药品监督管理局可以批准其他药品生产企业提出的生产该新药的申请,并重新对该新药进行监测。
Chapter VI Application and Approval of Import Drugs
   第七十条 新药进入监测期之日起,国家食品药品监督管理局已经批准其他申请人进行药物临床试验的,可以按照药品注册申报与审批程序继续办理该申请,符合规定的,国家食品药品监督管理局批准该新药的生产或者进口,并对境内药品生产企业生产的该新药一并进行监测。
Section 1 Registration of Import Drugs
   第七十一条 新药进入监测期之日起,不再受理其他申请人的同品种注册申请。已经受理但尚未批准进行药物临床试验的其他申请人同品种申请予以退回;新药监测期满后,申请人可以提出仿制药申请或者进口药品申请。
Article 84 A drug being applied for importation shall have already obtained the drug marketing authorization in the producing country or region where the overseas pharmaceutical manufacturer is located; those not yet obtained marketing authorization in the producing country or region, however confirmed with safety, efficacy and clinical needs by the State Food and Drug Administration may be approved for importation.
The production of a drug applied for importation shall comply with the GMP requirements of both the producing country or region where the drug manufacturer is located and China.
   第七十二条 进口药品注册申请首先获得批准后,已经批准境内申请人进行临床试验的,可以按照药品注册申报与审批程序继续办理其申请,符合规定的,国家食品药品监督管理局批准其进行生产;申请人也可以撤回该项申请,重新提出仿制药申请。对已经受理但尚未批准进行药物临床试验的其他同品种申请予以退回,申请人可以提出仿制药申请。
Article 85 To apply for import drug registration, the applicant shall fill the Application Form for Drug Registration, submit relevant dossiers and samples, provide relevant approval documents, and submit the application to the State Food and Drug Administration.
 

第五章 仿制药的申报与审批


Article 86 The State Food and Drug Administration shall conduct the preliminary review of the application dossiers, and issue an acceptance notice of drug registration application and notify the National Institute for the Control of Pharmaceutical and Biological Products to conduct testing for registration of samples from three batches if requirements are met; or issue a non-acceptance notice of drug registration application with reasons if requirements are not met.
The State Food and Drug Administration may organize to conduct on-site inspection of development and production conditions, and take samples.
   第七十三条 仿制药申请人应当是药品生产企业,其申请的药品应当与《药品生产许可证》载明的生产范围一致。
Article 87 The National Institute for the Control of Pharmaceutical and Biological Products shall organize to conduct the testing for drug registration within five days from the date it receives the dossiers and samples.
   第七十四条 仿制药应当与被仿制药具有同样的活性成份、给药途径、剂型、规格和相同的治疗作用。已有多家企业生产的品种,应当参照有关技术指导原则选择被仿制药进行对照研究。
Article 88 The drug testing institutes undertaking the import drug testing shall complete the testing for registration and submit the certificate of analysis for drug registration to the National Institute for the Control of Pharmaceutical and Biological Products within 60 days from the date they receive the documents, samples and relevant reference standards.
Sample testing and verification of specifications for controlled drugs or vaccines shall be completed within 90 days.
   第七十五条 申请仿制药注册,应当填写《药品注册申请表》,向所在地省、自治区、直辖市药品监督管理部门报送有关资料和生产现场检查申请。
Article 89 The National Institute for the Control of Pharmaceutical and Biological Products shall organize experts to conduct technical review within 20 days from the date it receives the certificate of analysis for drug registration and the verified import specifications, and if necessary, conduct further verification according to the review opinions.
   第七十六条 省、自治区、直辖市药品监督管理部门对申报资料进行形式审查,符合要求的,出具药品注册申请受理通知书;不符合要求的,出具药品注册申请不予受理通知书,并说明理由。
已申请中药品种保护的,自中药品种保护申请受理之日起至作出行政决定期间,暂停受理同品种的仿制药申请。
Article 90 After completing the testing for import drug registration, the National Institute for the Control of Pharmaceutical and Biological Products shall give the verified specifications, certificate of analysis and opinions thereof to the Center for Drug Evaluation of the State Food and Drug Administration, and copy the applicants.
   第七十七条 省、自治区、直辖市药品监督管理部门应当自受理申请之日起5日内组织对研制情况和原始资料进行现场核查,并应当根据申请人提供的生产工艺和质量标准组织进行生产现场检查,现场抽取连续生产的3批样品,送药品检验所检验。
样品的生产应当符合本办法第六十三条的规定。
Article 91 The Center for Drug Evaluation of the State Food and Drug Administration shall organize pharmaceutical, medical and other technical personnel to conduct technical review of the submitted dossiers within the specified timeline, and may request, with reasons, applicants to provide supplementary materials when necessary.
   第七十八条 省、自治区、直辖市药品监督管理部门应当在规定的时限内对申报资料进行审查,提出审查意见。符合规定的,将审查意见、核查报告、生产现场检查报告及申报资料送交国家食品药品监督管理局药品审评中心,同时通知申请人;不符合规定的,发给《审批意见通知件》,并说明理由,同时通知药品检验所停止该药品的注册检验。
Article 92 The Center for Drug Evaluation of the State Food and Drug Administration shall make a general opinion based on the technical review opinions and sample testing results, and report the general opinion together with relevant documents to the State Food and Drug Administration. The State Food and Drug Administration shall make a review and approval decision based on the general opinion. Where the regulations are conformed to, a Clinical Trial Approval shall be issued; where the regulations are not conformed to, a Disapproval Notice shall be issued with reasons.
   第七十九条 药品检验所应当对抽取的样品进行检验,并在规定的时间内将药品注册检验报告送交国家食品药品监督管理局药品审评中心,同时抄送通知其检验的省、自治区、直辖市药品监督管理部门和申请人。
Article 93 After a clinical trial application is approved, the applicant shall conduct the trial in accordance with the requirements in Chapter III of the Provisions and the other relevant requirements.
After a clinical trial is completed, the applicant shall fill the Application Form for Drug Registration, submit the clinical trial data, other altered and supplementary data in accordance with regulations, give in detail the basis and reasons, and provide relevant approved documents.
   第八十条 国家食品药品监督管理局药品审评中心应当在规定的时间内组织药学、医学及其他技术人员对审查意见和申报资料进行审核,必要时可以要求申请人补充资料,并说明理由。
Article 94 The Center for Drug Evaluation of the State Food and Drug Administration shall organize pharmaceutical, medical and other technical personnel to conduct comprehensive review of the submitted clinical trial data within the specified timeline, and may request, with reasons, applicants to provide supplementary materials when necessary.
The State Food and Drug Administration shall make a review and approval decision based on the general opinion. An Import Drug License shall be issued if regulations are conformed to. For a drug applied for registration by a drug manufacturer in Hong Kong, Macao or Taiwan of China, its application shall be handled in reference to the application procedures for import drug registration. If requirements are met, a Pharmaceutical Product License shall be issued; if requirements are not met, a Disapproval Notice shall be issued with reasons.
   第八十一条 国家食品药品监督管理局药品审评中心依据技术审评意见、样品生产现场检查报告和样品检验结果,形成综合意见,连同相关资料报送国家食品药品监督管理局,国家食品药品监督管理局依据综合意见,做出审批决定。符合规定的,发给药品批准文号或者《药物临床试验批件》;不符合规定的,发给《审批意见通知件》,并说明理由。
Article 95 To apply for importation of pharmaceutical preparations, approved documents for the lawful sources of the immediate packaging materials and containers and those of the drug substances and the excipients used for the pharmaceutical preparations shall be provided. Where drug substances and excipients are not yet approved by the State Food and Drug Administration, relevant data of manufacturing processes, specifications and testing methods, etc. shall be submitted.
   第八十二条 申请人完成临床试验后,应当向国家食品药品监督管理局药品审评中心报送临床试验资料。国家食品药品监督管理局依据技术意见,发给药品批准文号或者《审批意见通知件》。
Section 2 Registration of Import Drug Repackaging
   第八十三条 已确认存在安全性问题的上市药品,国家食品药品监督管理局可以决定暂停受理和审批其仿制药申请。
Article 96 The import drug repackaging refers to dividing a large pack into small ones in China or adding outer-package to a drug with inner-package, placing insert sheets and attaching labels, etc., after the production process of the finished pharmaceutical preparations for the drug are completed overseas .
 

第六章 进口药品的申报与审批


Article 97 To apply for import drug repackaging, the following requirements shall be met:
 

第一节 进口药品的注册


(1) the Import Drug License or Pharmaceutical Product License of the drug is already obtained;(2) the drug shall be one that is not produced within the territory of China, or is produced in China but unable to meet clinical needs;(3) one drug produced by a drug manufacturer shall be repackaged by only one drug manufacturer. The term allowed for repackaging shall not exceed the expiry date of the Import Drug License or Pharmaceutical Product License;(4) the inner–packaging of a drug in any dosage form for repackaging, except tablets and capsules, shall be completed overseas;(5) a drug manufacturer that conducts repackaging shall hold the Drug Manufacturing Certificate. To apply for repackaging of import unpackaged tablets and capsules, the manufacturer shall also hold the GMP certificate covering the dosage forms for repackaging; and(6) An application for drug repackaging shall be made one year prior to the expiration of the Import Drug License or the Pharmaceutical Product License.
   第八十四条 申请进口的药品,应当获得境外制药厂商所在生产国家或者地区的上市许可;未在生产国家或者地区获得上市许可,但经国家食品药品监督管理局确认该药品安全、有效而且临床需要的,可以批准进口。
申请进口的药品,其生产应当符合所在国家或者地区药品生产质量管理规范及中国《药品生产质量管理规范》的要求。
Article 98 An overseas drug manufacturer shall sign a contract for import drug repackaging with a domestic drug manufacturer, and fill in the Drug Supplementary Application Form.
   第八十五条 申请进口药品注册,应当填写《药品注册申请表》,报送有关资料和样品,提供相关证明文件,向国家食品药品监督管理局提出申请。
Article 99 To apply for the repackaging of an import drug, the drug manufacturer entrusted with repackaging of the drug shall submit an application to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where it is located. The trustee shall submit the Supplementary Drug Application Form filled in by the truster, the relevant data and samples as well as the contract of entrustment, etc. The drug regulatory department shall conduct the preliminary review of the submitted documents. Where requirements are met, it shall issue a notice of acceptance; where requirements are not met, it shall issue a notice of non-acceptance with reasons.
The drug regulatory department shall make review opinions, then submit the application documents and review opinions to the State Food and Drug Administration and inform the applicant at the same time.
   第八十六条 国家食品药品监督管理局对申报资料进行形式审查,符合要求的,出具药品注册申请受理通知书,并通知中国药品生物制品检定所组织对3个生产批号的样品进行注册检验;不符合要求的,出具药品注册申请不予受理通知书,并说明理由。
国家食品药品监督管理局可以组织对其研制和生产情况进行现场检查,并抽取样品。
Article 100 The State Food and Drug Administration shall review the submitted documents. Where the regulations are conformed to, it shall issue an Approval for Supplementary Drug Application and a drug approval number; where the regulations are not conformed to, it shall issue a Disapproval Notice with reasons.
   第八十七条 中国药品生物制品检定所收到资料和样品后,应当在5日内组织进行注册检验。
Article 101 The repackaged import drugs shall comply with the registration specifications for import drugs.
   第八十八条 承担进口药品注册检验的药品检验所在收到资料、样品和有关标准物质后,应当在60日内完成注册检验并将药品注册检验报告报送中国药品生物制品检定所。
特殊药品和疫苗类制品的样品检验和药品标准复核应当在90日内完成。
Article 102 The insert sheets and labels of a repackaged import drug shall be in conformity with those of the import drug, and shall be indicated with the approval number of the repackaging drug and the name of drug manufacturer.
   第八十九条 中国药品生物制品检定所接到药品注册检验报告和已经复核的进口药品标准后,应当在20日内组织专家进行技术审查,必要时可以根据审查意见进行再复核。
Article 103 The testing for import of overseas pharmaceutical preparation in large package shall be conducted according to the State Food and Drug Administration regulations. The same specifications shall be used for the testing of both repackaged and import products.
   第九十条 中国药品生物制品检定所完成进口药品注册检验后,应当将复核的药品标准、药品注册检验报告和复核意见送交国家食品药品监督管理局药品审评中心,并抄送申请人。
Article 104 The overseas drug manufacturer providing the drug shall be responsible for the quality of the repackaged drug. If there is any quality problem, the State Food and Drug Administration may withdraw the approval number of the repackaged drug, revoke the Import Drug License or the Pharmaceutical Product License when necessary according to the requirements of Article 42 of the Drug Administration Law.
   第九十一条 国家食品药品监督管理局药品审评中心应当在规定的时间内组织药学、医学及其他技术人员对申报资料进行审评,必要时可以要求申请人补充资料,并说明理由。
Chapter VII Application of Non-Prescription Drugs
   第九十二条 国家食品药品监督管理局药品审评中心依据技术审评意见和样品检验结果等,形成综合意见,连同相关资料报送国家食品药品监督管理局,国家食品药品监督管理局依据综合意见,做出审批决定。符合规定的,发给《药物临床试验批件》;不符合规定的,发给《审批意见通知件》,并说明理由。
Article 105 Where the applied generic drug is regulated as a non-prescription drug, the applicant shall indicate the item of non-prescription drug in the "additional application items" of the Application Form for Drug Registration.
   第九十三条 临床试验获得批准后,申请人应当按照本办法第三章及有关要求进行试验。
临床试验结束后,申请人应当填写《药品注册申请表》,按照规定报送临床试验资料及其他变更和补充的资料,并详细说明依据和理由,提供相关证明文件。
Article 106 Where the applied generic drug is regulated as both a prescription and non-prescription drug, the applicant may submit an application for either a prescription or non-prescription drug according to the respective requirements.
   第九十四条 国家食品药品监督管理局药品审评中心应当在规定的时间内组织药学、医学及其他技术人员对报送的临床试验等资料进行全面审评,必要时可以要求申请人补充资料,并说明理由。
国家食品药品监督管理局依据综合意见,做出审批决定。符合规定的,发给《进口药品注册证》。中国香港、澳门和台湾地区的制药厂商申请注册的药品,参照进口药品注册申请的程序办理,符合要求的,发给《医药产品注册证》;不符合要求的,发给《审批意见通知件》,并说明理由。
Article 107 For any of the following circumstances, the applicant may indicate the item of non-prescription drug in the "additional application items" of the Application Form for Drug Registration. If relevant requirements for non-prescription drugs apply, the drug shall be reviewed and approved, and regulated as a non-prescription drug; if relevant requirements for non-prescription drugs do not apply, it shall be reviewed and approved, and regulated as a prescription drug:
   第九十五条 申请进口药品制剂,必须提供直接接触药品的包装材料和容器合法来源的证明文件、用于生产该制剂的原料药和辅料合法来源的证明文件。原料药和辅料尚未取得国家食品药品监督管理局批准的,应当报送有关生产工艺、质量指标和检验方法等规范的研究资料。
(1) To alter the dosage form of a non-prescription drug determined by the State Food and Drug Administration without changing the indications or functions, dosage and route of administration; or(2) To formulate a new fixed dose combination using active ingredients of non-prescription drugs determined by the State Food and Drug Administration.
 

第二节 进口药品分包装的注册


Article 108 For the registration application of a non-prescription drug, the insert sheet and package label shall comply with the relevant regulations on non-prescription drugs.
   第九十六条 进口药品分包装,是指药品已在境外完成最终制剂生产过程,在境内由大包装规格改为小包装规格,或者对已完成内包装的药品进行外包装、放置说明书、粘贴标签等。
Article 109 For the registration application of an import drug categorized as non-prescription drug, the application, review and approval procedures for import drugs shall apply, and the technological requirements shall be the same as those for the domestically produced non-prescription drugs.
   第九十七条 申请进口药品分包装,应当符合下列要求:
Chapter VIII Submission, Review and Approval of Supplementary Application
 (一)该药品已经取得《进口药品注册证》或者《医药产品注册证》;
Article 110 For the variation of the items specified in the approval document and its attachment for approved new drug development, drug production and import drug, supplementary applications shall be made.
The applicant shall assess the implications of the variation to the safety, efficacy and quality of the drug, and conduct corresponding technical studies in reference to relevant technical guidelines.
 (二)该药品应当是中国境内尚未生产的品种,或者虽有生产但是不能满足临床需要的品种;
Article 111 The applicant shall fill in Supplementary Drug Application Form and submit relevant dossier and explanation to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located. Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall conduct the preliminary review of the application dossiers, and issue an acceptance notice of drug registration application if requirements are met, or issue a non-acceptance notice, with reasons, of drug registration application if requirements are not met.
 (三)同一制药厂商的同一品种应当由一个药品生产企业分包装,分包装的期限不得超过《进口药品注册证》或者《医药产品注册证》的有效期;
Article 112 For the supplementary application of an import drug, the applicant shall submit relevant dossier and explanations to the State Food and Drug Administration, and provide documents approving the variation issued by the drug regulatory department of the producing country or region. The State Food and Drug Administration shall conduct the preliminary review of the application dossiers, and issue an acceptance notice of drug registration application if requirements are met, or issue a non-acceptance notice, in which reasons shall be given, of drug registration application if requirements are not met.
 (四)除片剂、胶囊外,分包装的其他剂型应当已在境外完成内包装;
Article 113 For any supplementary application to amend the drug registration specifications, change excipients for pharmaceutical use in the drug formulation, or modify the manufacturing process that affects the drug quality, etc., the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall provide a review opinion, report it to the State Food and Drug Administration for review and approval, and inform the applicant at the same time.
For supplementary application to amend the drug registration specifications, the drug testing institute shall verify the specifications when necessary.
 (五)接受分包装的药品生产企业,应当持有《药品生产许可证》。进口裸片、胶囊申请在国内分包装的,接受分包装的药品生产企业还应当持有与分包装的剂型相一致的《药品生产质量管理规范》认证证书;
Article 114 For any supplementary application to change the name of a domestic drug manufacturer, the shelf-life of a domestically produced drug, or the production site by a domestic drug manufacturer internally, etc., the drug regulatory departments of the provinces, autonomous regions, or municipalities directly under the Central Government shall conduct the acceptance, review and approval. Where the regulations are conformed to, it shall issue an Approval for Supplementary Drug Application, and report to the State Food and Drug Administration for record; where the regulations are not conformed to, it shall issue a Disapproval Notice with reasons.
 (六)申请进口药品分包装,应当在该药品《进口药品注册证》或者《医药产品注册证》的有效期届满1年前提出。
Article 115 Any supplementary application to alter drug packaging label in accordance with regulations, or amend the insert sheet as required by the State Food and Drug Administration, etc. shall be filed to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government for record.
   第九十八条 境外制药厂商应当与境内药品生产企业签订进口药品分包装合同,并填写《药品补充申请表》。
Article 116 Supplementary applications of import drugs shall be reviewed and approved by the State Food and Drug Administration. Those supplementary applications to change the place of production of the drug substance used for any import drug preparation, change the appearance of an import drug not resulting in specification changes, amend the insert sheet of an import drug according to the national specifications or the requirements of the State Food and Drug Administration, update the safety information in the insert sheet of an import drug, alter drug packaging label in accordance with regulations, or change the registration agent shall be filed to the State Food and Drug Administration for record.
   第九十九条 申请进口药品分包装的,应当由接受分包装的药品生产企业向所在地省、自治区、直辖市药品监督管理部门提出申请,提交由委托方填写的《药品补充申请表》,报送有关资料和样品。省、自治区、直辖市药品监督管理部门对申报资料进行形式审查后,符合要求的,出具药品注册申请受理通知书;不符合要求的,出具药品注册申请不予受理通知书,并说明理由。
省、自治区、直辖市药品监督管理部门提出审核意见后,将申报资料和审核意见报送国家食品药品监督管理局审批,同时通知申请人。
Article 117 For supplementary applications of drug manufacturing technology transfer, altering formula or manufacturing process that may affect product quality, etc., the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall organize production site inspection, according to the attachment of the Letter of Approval for Drug Registration or the verified manufacturing process. Drug testing institutes shall conduct testing on samples of three batches of product.
   第一百条 国家食品药品监督管理局对报送的资料进行审查,符合规定的,发给《药品补充申请批件》和药品批准文号;不符合规定的,发给《审批意见通知件》,并说明理由。
Article 118 While reviewing drug supplementary applications, the State Food and Drug Administration may require, with reasons, the applicants to submit additional documents when necessary. Where the regulations are conformed to, it shall issue an Approval for Supplementary Drug Application and a drug approval number; where the regulations are not conformed to, it shall issue a Disapproval Notice with reasons.
   第一百零一条 进口分包装的药品应当执行进口药品注册标准。
Article 119 After the supplementary application is approved, if a drug approval document is to be renewed, the original one shall be cancelled by the State Food and Drug Administration; if an additional drug approval certificate is to be issued, the original one shall remain valid.
   第一百零二条 进口分包装药品的说明书和标签必须与进口药品的说明书和标签一致,并且应当标注分包装药品的批准文号和分包装药品生产企业的名称。
Chapter IX Drug Re-Registration
   第一百零三条 境外大包装制剂的进口检验按照国家食品药品监督管理局的有关规定执行。包装后产品的检验与进口检验执行同一药品标准。
Article 120 The valid term of a drug approval number, Import Drug License or Pharmaceutical Product License issued by the State Food and Drug Administration is five years. To continue its drug production or importation, the applicant shall submit a re-registration application six months prior to the expiry date.
   第一百零四条 提供药品的境外制药厂商应当对分包装后药品的质量负责。分包装后的药品出现质量问题的,国家食品药品监督管理局可以撤销分包装药品的批准文号,必要时可以依照《药品管理法》四十二条的规定,撤销该药品的《进口药品注册证》或者《医药产品注册证》。
Article 121 Within the valid term of a drug approval number, Import Drug License or Pharmaceutical Product License, the applicant shall conduct systematic assessment on the safety, efficacy and quality control of the drug such as relevant research results in the observation period, adverse reaction monitoring, production control and product quality consistency, etc.
 

第七章 非处方药的申报


Article 122 Where applying for drug re-registration, the holder of a drug approval number shall submit the application to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, fill in the Application Form for Drug Re-registration, and provide relevant data.
Where applying for an import drug re-registration, the applicant shall submit the application to the State Food and Drug Administration.
   第一百零五条 申请仿制的药品属于按非处方药管理的,申请人应当在《药品注册申请表》的“附加申请事项”中标注非处方药项。
Article 123 Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall review the application dossiers, and issue a acceptance notice of drug re-registration application if requirements are met, or issue a non-acceptance notice, in which reasons shall be given, of drug re-registration application if requirements are not met.
   第一百零六条 申请仿制的药品属于同时按处方药和非处方药管理的,申请人可以选择按照处方药或者非处方药的要求提出申请。
Article 124 Drug regulatory departments of provinces, autonomous regions, or municipalities directly under the Central Government shall review the application dossiers within six months starting from the date of acceptance, and approve the re-registration application if regulations are conformed to, or report to the State Food and Drug Administration if regulations are not conformed to.
   第一百零七条 属于以下情况的,申请人可以在《药品注册申请表》的“附加申请事项”中标注非处方药项,符合非处方药有关规定的,按照非处方药审批和管理;不符合非处方药有关规定的,按照处方药审批和管理。
Article 125 The State Food and Drug Administration shall deal with import drug re-registration applications, complete the review within six months, and approve the re-registration application if regulations are conformed to, or issue a non-acceptance notice, in which reasons shall be given, if regulations are not conformed to.
 (一)经国家食品药品监督管理局确定的非处方药改变剂型,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;
Article 126 In any of the following circumstances, a drug shall not be re-registered:
 (二)使用国家食品药品监督管理局确定的非处方药活性成份组成的新的复方制剂。
(1) the application for re-registration is not made prior to the expiry date;(2) the relevant requirements set by the State Food and Drug Administration when approved for marketing are not met;(3) the phase IV clinical trial is not completed as required;(4) the adverse drug reaction monitoring is not conducted in accordance with regulations;(5) there are uncertain therapeutic efficacy, serious adverse reaction or other factors harmful to human health upon re-evaluation by the State Food and Drug Administration;(6) the drug approval documents shall be withdrawn in accordance with the provisions of the Drug Administration Law;(7) the production conditions prescribed in the Drug Administration Law are not met;(8) the obligation of observation period is not fulfilled in accordance with regulations; or(9) there are other circumstances not in conformity with relevant regulations.
   第一百零八条 非处方药的注册申请,其药品说明书和包装标签应当符合非处方药的有关规定。
Article 127 After receiving the opinions from the drug regulatory departments of the provinces, autonomous regions, or municipalities directly under the Central Government, the State Food and Drug Administration shall review the application. Where the regulations on drug re-registration are not conformed to, a notice of rejection for re-registration shall be issued with reasons.
Where a re-registration application has been rejected, except where the drug approval document is withdrawn due to lawfully defined reasons, the drug approval number, Dug Import License or Pharmaceutical Production Certificate shall be withdrawn on the expiry date.
   第一百零九条 进口的药品属于非处方药的,适用进口药品的申报和审批程序,其技术要求与境内生产的非处方药相同。
Chapter X Testing for Drug Registration
 

第八章 补充申请的申报与审批


Article 128 Testing for drug registration consists of sample testing and verification of specifications.
Sample testing refers to the testing of samples conducted by a drug testing institute according to the specifications submitted by an applicant or checked by the State Food and Drug Administration.
Verification of specifications refers to the laboratory testing and review conducted by a drug testing institute on the feasibility and scientific basis of the testing methods and the controllability of the set items and indicators of drug quality in the submitted specifications.
   第一百一十条 变更研制新药、生产药品和进口药品已获批准证明文件及其附件中载明事项的,应当提出补充申请。
申请人应当参照相关技术指导原则,评估其变更对药品安全性、有效性和质量可控性的影响,并进行相应的技术研究工作。
Article 129 The National Institute for the Control of Pharmaceutical and Biological Products or the drug testing institutes of the provinces, autonomous regions, and municipalities directly under the Central Government shall take charge of the testing for drug registration. The National Institute for the Control of Pharmaceutical and Biological Products shall arrange testing for import drug registration.
   第一百一十一条 申请人应当填写《药品补充申请表》,向所在地省、自治区、直辖市药品监督管理部门报送有关资料和说明。省、自治区、直辖市药品监督管理部门对申报资料进行形式审查,符合要求的,出具药品注册申请受理通知书;不符合要求的,出具药品注册申请不予受理通知书,并说明理由。
Article 130 The testing for registration of the following drugs shall be conducted by the National Institute for the Control of Pharmaceutical and Biological Products or the drug testing institutes designated by the State Food and Drug Administration:
   第一百一十二条 进口药品的补充申请,申请人应当向国家食品药品监督管理局报送有关资料和说明,提交生产国家或者地区药品管理机构批准变更的文件。国家食品药品监督管理局对申报资料进行形式审查,符合要求的,出具药品注册申请受理通知书;不符合要求的,出具药品注册申请不予受理通知书,并说明理由。
(1) drugs prescribed in subparagraph (1) and (2) of Article 45 of the Provisions;(2) biological products and radioactive pharmaceuticals; and(3) other drugs specified by the State Food and Drug Administration.
   第一百一十三条 修改药品注册标准、变更药品处方中已有药用要求的辅料、改变影响药品质量的生产工艺等的补充申请,由省、自治区、直辖市药品监督管理部门提出审核意见后,报送国家食品药品监督管理局审批,同时通知申请人。
修改药品注册标准的补充申请,必要时由药品检验所进行标准复核。
Article 131 Where a drug is permitted entering a special review and approval procedure, the drug testing institute shall give priority to sample testing and specification verification.
   第一百一十四条 改变国内药品生产企业名称、改变国内生产药品的有效期、国内药品生产企业内部改变药品生产场地等的补充申请,由省、自治区、直辖市药品监督管理部门受理并审批,符合规定的,发给《药品补充申请批件》,并报送国家食品药品监督管理局备案;不符合规定的,发给《审批意见通知件》,并说明理由。
Article 132 A drug testing institute engaged in testing for drug registration shall, in compliance with the requirements set forth by the Good Laboratory Practice of drug testing institute and national metrology accreditation, have qualified personnel and adequate equipment, and comply with the quality assurance system and technical requirements of the testing for drug registration.
   第一百一十五条 按规定变更药品包装标签、根据国家食品药品监督管理局的要求修改说明书等的补充申请,报省、自治区、直辖市药品监督管理部门备案。
Article 133 An applicant shall provide the relevant data, samples and reference standards, or assist in sampling, which are required for the testing for drug registration. The amount of samples shall be three times the amount used for testing and, for biological products, manufacturing record for the relevant batches of products shall also be provided.
   第一百一十六条 进口药品的补充申请,由国家食品药品监督管理局审批。其中改变进口药品制剂所用原料药的产地、变更进口药品外观但不改变药品标准、根据国家药品标准或国家食品药品监督管理局的要求修改进口药说明书、补充完善进口药说明书的安全性内容、按规定变更进口药品包装标签、改变注册代理机构的补充申请,由国家食品药品监督管理局备案。
Article 134 While verifying the specifications of a new drug, the drug testing institute shall, in addition to sample testing, give verification opinions in respect of the specifications and test items, etc., of the drug referring to the study data, the specifications of the same kind of products at home and abroad and relevant requirements.
   第一百一十七条 对药品生产技术转让、变更处方和生产工艺可能影响产品质量等的补充申请,省、自治区、直辖市药品监督管理部门应当根据其《药品注册批件》附件或者核定的生产工艺,组织进行生产现场检查,药品检验所应当对抽取的3批样品进行检验。
Article 135 Where the specifications are required to be reestablished, the applicant shall not entrust the drug testing institute that gave verification opinions to conduct the specification study of the drug; and the drug testing institute shall not accept such entrustment.
   第一百一十八条 国家食品药品监督管理局对药品补充申请进行审查,必要时可以要求申请人补充资料,并说明理由。符合规定的,发给《药品补充申请批件》;不符合规定的,发给《审批意见通知件》,并说明理由。
Chapter XI Drug Registration Specifications and Insert Sheet
   第一百一十九条 补充申请获得批准后,换发药品批准证明文件的,原药品批准证明文件由国家食品药品监督管理局予以注销;增发药品批准证明文件的,原批准证明文件继续有效。
Section 1 Drug Registration Specifications
 

第九章 药品再注册


Article 136 National drug standards refer to the Pharmacopoeia of the People's Republic of China, drug registration specifications, etc. published by the State Food and Drug Administration, including the technical requirements such as specifications, testing methods and manufacturing processes, etc.
Drug registration specifications refer to the specified specifications of the applied drug approved by the State Food and Drug Administration to the applicant. The specifications shall be implemented by the drug manufacturer producing the drug.
Drug registration specifications shall not be lower than those required by the Chinese Pharmacopoeia.
   第一百二十条 国家食品药品监督管理局核发的药品批准文号、《进口药品注册证》或者《医药产品注册证》的有效期为5年。有效期届满,需要继续生产或者进口的,申请人应当在有效期届满前6个月申请再注册。
Article 137 The establishment of items and the testing methods for drug registration specifications shall be in conformity with the basic requirements of the Chinese Pharmacopoeia, the technical guidelines and rules for compiling the national drug standards published by the State Food and Drug Administration.
   第一百二十一条 在药品批准文号、《进口药品注册证》或者《医药产品注册证》有效期内,申请人应当对药品的安全性、有效性和质量控制情况,如监测期内的相关研究结果、不良反应的监测、生产控制和产品质量的均一性等进行系统评价。
Article 138 An applicant shall select representative samples for drug registration specifications study.
   第一百二十二条 药品再注册申请由药品批准文号的持有者向省、自治区、直辖市药品监督管理部门提出,按照规定填写《药品再注册申请表》,并提供有关申报资料。
进口药品的再注册申请由申请人向国家食品药品监督管理局提出。
Section 2 Drug Reference Standards
   第一百二十三条 省、自治区、直辖市药品监督管理部门对申报资料进行审查,符合要求的,出具药品再注册申请受理通知书;不符合要求的,出具药品再注册申请不予受理通知书,并说明理由。
Article 139 Drug reference standards refer to the materials used in physical, chemical or biological testing specified in specifications and have assigned values of a quantity, and are used for equipment calibration, method validation or value assignment of drugs to be tested, and include reference standards, reference substances, reference crude drugs and reference reagents.
   第一百二十四条 省、自治区、直辖市药品监督管理部门应当自受理申请之日起6个月内对药品再注册申请进行审查,符合规定的,予以再注册;不符合规定的,报国家食品药品监督管理局。
Article 140 The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for the characterization of national reference standards.
The National Institute for the Control of Pharmaceutical and Biological Products may organize relevant drug testing institute of provinces, autonomous regions, and municipalities directly under the Central Government, drug research institutions or drug manufacturers to undertake collaborative assays of such standards.
   第一百二十五条 进口药品的再注册申请由国家食品药品监督管理局受理,并在6个月内完成审查,符合规定的,予以再注册;不符合规定的,发出不予再注册的通知,并说明理由。
Article 141 The National Institute for the Control of Pharmaceutical and Biological Products shall be responsible for the overall technical evaluation of the characterized reference standards in respect of the data of source material selection, preparation methods, testing methods and results, accuracy of value assignment, traceability, stability, filling and packaging conditions, etc. and shall conclude whether or not the candidate materials can be used as national reference standards.
   第一百二十六条 有下列情形之一的药品不予再注册:
Section 3 Drug Name, Insert Sheet and Label
 (一)有效期届满前未提出再注册申请的;
Article 142 The name, insert sheet and label of any drug for which the registration is applied, shall comply with the provisions of the State Food and Drug Administration.
 (二)未达到国家食品药品监督管理局批准上市时提出的有关要求的;
Article 143 The drug insert sheet and label shall be provided by the applicant. The Center for Drug Evaluation of the State Food and Drug Administration shall review the contents thereof except the manufacturer information, and the State Food and Drug Administration shall review and approve the data when approving the drug production.
The applicant shall be responsible for making the drug insert sheet and label scientific, standard and accurate.
 (三)未按照要求完成IV期临床试验的;
Article 144 The applicant shall monitor the safety and efficacy of a marketed drug, and submit supplementary application to modify the drug insert sheet in time.
 (四)未按照规定进行药品不良反应监测的;
Article 145 The applicant shall print the insert sheets and labels according to the format and requirements established by the State Food and Drug Administration, and in conformity with the contents approved.
 (五)经国家食品药品监督管理局再评价属于疗效不确、不良反应大或者其他原因危害人体健康的;
Chapter XII Timeline
 (六)按照《药品管理法》的规定应当撤销药品批准证明文件的;
Article 146 The drug regulatory department shall follow the provisions on the timeline for drug registration set forth in the Drug Administration Law, the Administrative Permission Law and the Regulations for Implementation of the Drug Administration Law. The timeline for drug registration in the Provisions refers to the maximum time for acceptance, review and approval of drug registration. The time for the suspension of the review and approval prescribed in laws and regulations or for the applicant to supplement data is not included.
The time for the testing for drug registration and for the review shall be kept in accordance with the Provisions. Where there is a need for time extension in particular situation, it, with reasons provided, shall be reported to the State Food and Drug Administration for approval, and the applicant shall be informed thereof.
 (七)不具备《药品管理法》规定的生产条件的;
Article 147 Drug regulatory departments shall conduct preliminary review on applications, and proceed according to the following circumstances respectively:
 (八)未按规定履行监测期责任的;
(1) Where no administrative approval is needed for any application item by law, the non-acceptance of the application thereof shall be informed to the applicant in time;(2) Where an application item is not subject to the jurisdiction of the concerned departments by law, it shall be decided not to accept the application in time and informed to the applicant to apply to the relevant administrative departments;(3) Where there is an error that can be corrected on-site in the dossier, the on-site correction shall be allowed;(4) Where the dossier is incomplete or not conformed with the defined format, the applicant shall be informed on-site or within five days at once of what to be supplemented or corrected; if it is not informed to the applicant within the timeline, the application is regarded as accepted on the date the dossier is received; and(5) Where the application item is subject to the jurisdiction of the concerned departments, and the dossier is complete and conformed with the defined format or the applicant has submitted all the required supplementary or corrected data, the application of drug registration shall be accepted.
Where a drug regulatory department accepts or rejects a drug registration application, it shall issue a written receipt on which there shall be a stamp of registration and date.
 (九)其他不符合有关规定的情形。
Article 148 The drug regulatory department of a province, autonomous region, or municipality directly under the Central Government shall complete the check of drug development conditions and raw data, the review of application dossiers, sampling, the notice to drug testing institutes for conducting testing for drug registration, the submission of review opinions, inspection report and application dossiers to the State Food and Drug Administration, and the notice to the applicant of the review opinions within 30 days starting from the date an application is accepted.
   第一百二十七条 国家食品药品监督管理局收到省、自治区、直辖市药品监督管理部门意见后,经审查不符合药品再注册规定的,发出不予再注册的通知,并说明理由。
对不予再注册的品种,除因法定事由被撤销药品批准证明文件的外,在有效期届满时,注销其药品批准文号、《进口药品注册证》或者《医药产品注册证》。
Article 149 The time for the testing for drug registration shall be kept in accordance with the following provisions:
 

第十章 药品注册检验


(1) sample testing: 30 days; sample testing and specifications verification : 60 days; and(2) sample testing of a controlled drug or vaccine: 60 days; sample testing and specifications verification: 90 days.
The sample testing for a drug used for clinical trial conducted by a drug testing institute, as prescribed in Article 36 of the Provisions, shall be completed within the time for sample testing in the previous clause.
   第一百二十八条 药品注册检验,包括样品检验和药品标准复核。
样品检验,是指药品检验所按照申请人申报或者国家食品药品监督管理局核定的药品标准对样品进行的检验。
药品标准复核,是指药品检验所对申报的药品标准中检验方法的可行性、科学性、设定的项目和指标能否控制药品质量等进行的实验室检验和审核工作。
Article 150 The time for technical review shall be kept in accordance with the following provisions:
   第一百二十九条 药品注册检验由中国药品生物制品检定所或者省、自治区、直辖市药品检验所承担。进口药品的注册检验由中国药品生物制品检定所组织实施。
(1) new drug application for clinical trial: 90 days; any drug permitted to enter the special review and approval procedures: 80 days;(2) new drug application for production: 150 days; any drug permitted to enter the special review and approval procedures: 120 days;(3) the application for changing the dosage form of a marketed drug or for a generic drug: 160 days; and(4) the supplementary application subject to technical review: 40 days.
The time for the technical review of an import drug registration application shall be kept in accordance with the previous clause.
   第一百三十条 下列药品的注册检验由中国药品生物制品检定所或者国家食品药品监督管理局指定的药品检验所承担:
Article 151 Where the applicant is required to supplement data in the process of technical review, a Deficiency Notice should be issued at one time. Where the applicant disagrees on the contents of the Deficiency Notice, the opinions of the applicant may be heard vis-à-vis. The applicant shall provide supplementary data at one time according to the requirements in the notice within four months; where an application enters the special review and approval procedures, it shall be handled in conformity with the requirements of the relevant procedures.
After receiving the supplementing data, the technical review shall be completed in no more than one third of the original time; for applications entering the special review and approval procedures, the review shall be completed in no more than one fourth of the original time.
Where an application is recalled by the applicant in the process of drug registration, the review and approval procedure is terminated henceforth.
 (一)本办法第四十五条(一)、(二)规定的药品;
Article 152 The State Food and Drug Administration shall make the review and approval decision within 20 days; where a decision cannot be made within 20 days, another ten days may be extended with the approval of the State Food and Drug Administration head in charge, and the applicant shall be informed of the reason of the time extended.
 (二)生物制品、放射性药品;
Article 153 The State Food and Drug Administration shall issue and deliver relevant administrative licensing certificates within ten days from the date the review and approval decision is made.
 (三)国家食品药品监督管理局规定的其他药品。
Chapter XIII Second Review
   第一百三十一条 获准进入特殊审批程序的药品,药品检验所应当优先安排样品检验和药品标准复核。
Article 154 Where there is any of the following circumstances, the State Food and Drug Administration shall not approve the application:
......
   第一百三十二条 从事药品注册检验的药品检验所,应当按照药品检验所实验室质量管理规范和国家计量认证的要求,配备与药品注册检验任务相适应的人员和设备,符合药品注册检验的质量保证体系和技术要求。
......



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