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Order of the State Food and Drug Administration
(No. 17)
The Measures for the Administration of Drug Registration were deliberated and adopted at the executive meeting of the State Food and Drug Administration. They are hereby promulgated and shall be implemented as of May 1, 2005.
Director Zheng Xiaoyu
February 28, 2005
Measures for the Administration of Drug Registration
| | 國家食品藥品監督管理局令
（第17號）
《藥品注冊管理辦法》經國家食品藥品監督管理局局務會審議通過，現予公布，自2005年5月1日起施行。
局長：鄭筱萸
二00五年二月二十八日
藥品注冊管理辦法
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Chapter I. General Provisions
| | 第一章 總則
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Article 1 For the purposes of ensuring the safety, effectiveness and controllable quality of drugs and regulating the drug registration behavior, these Measures are formulated in accordance with the Medicinal Product Administration Law of the People's Republic of China (hereinafter referred to as Medicinal Product Administration Law) and the Regulation for the Implementation of the Medicinal Product Administration Law of the People's Republic of China (hereinafter referred to as the Regulation for the Implementation of the Medicinal Product Administration Law).
| | 第一條 為保證藥品的安全、有效和質量可控，規範藥品注冊行為，根據《中華人民共和國藥品管理法》（以下簡稱《藥品管理法》）、《中華人民共和國藥品管理法實施條例》（以下簡稱《藥品管理法實施條例》），制定本辦法。
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Article 2 These Measures shall apply to the application for drug clinical trials, drug production or import, as well as the relevant matters concerning drug registration, inspection, supervision and administration undertaken within the People's Republic of China.
| | 第二條 在中華人民共和國境內申請進行藥物臨床試驗、藥品生產或者進口、進行相關的藥品注冊檢驗以及監督管理，適用本辦法。
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Article 3 “Drug registration” refers to the examination and approval process during which the State Food and Drug Administration (hereinafter referred to as the SFDA) conducts, at the drug registration application filed by an applicant, a systematic evaluation of the safety, effectiveness and quality controllability of the drug to be marketed, and makes the decision on whether or not to approve the application in accordance with the statutory procedures.
| | 第三條 藥品注冊，是指國家食品藥品監督管理局根據藥品注冊申請人的申請，依照法定程序，對擬上市銷售的藥品的安全性、有效性、質量可控性等進行系統評價，並決定是否同意其申請的審批過程。
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Article 4 The state encourages the study and development of new drugs, and employs the system of expedite examination and approval to new drugs developed, new drugs for treating complicated and serious diseases as well as the drugs badly needed for emergencies.
| | 第四條 國家鼓勵研究創制新藥，對創制的新藥、治療疑難危重疾病的新藥和突發事件應急所需的藥品實行快速審批。
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Article 5 The SFDA shall be in charge of the administration of drug registration throughout the country, and be responsible for the examination and approval of drug clinical trials, drug manufacturing and import.
The (food) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall verify the research and development as well as the conditions, examine the completeness, standardization and authenticity of the application materials for drug registration, and organize a test of trial samples.
| | 第五條 國家食品藥品監督管理局主管全國藥品注冊工作，負責對藥物臨床試驗、藥品生產和進口進行審批。
省、自治區、直轄市（食品）藥品監督管理部門依法對申報藥物的研制情況及條件進行核查，對藥品注冊申報資料的完整性、規範性和真實性進行審核，並組織對試制的樣品進行檢驗。
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Article 6 An applicant for drug registration (hereinafter referred to as the applicant) refers to an institution that files an application for drug registration, bears the corresponding legal liabilities, and holds the drug approval documents after the application is approved.
A domestic applicant shall be an institution that is lawfully registered within China and can bear civil liabilities independently, while an overseas applicant is a lawful overseas drug manufacturer. Where an overseas applicant applies for the registration of drug import, its office based in China or an agency within China entrusted thereby shall go through the formalities for the registration of the imported drugs.
The personnel handling the applications for drug registration shall be professionals in corresponding fields, and shall be familiar with the laws and regulations and technical requirements for the administration of drug registration.
| | 第六條 藥品注冊申請人（以下簡稱申請人），是指提出藥品注冊申請，承擔相應法律責任，並在該申請獲得批准後持有藥品批准證明文件的機構。
境內申請人應當是在中國境內合法登記並能獨立承擔民事責任的機構，境外申請人應當是境外合法制藥廠商。境外申請人辦理進口藥品注冊，應當由其駐中國境內的辦事機構或者由其委托的中國境內代理機構辦理。
辦理藥品注冊申請事務的人員應當是相應的專業技術人員，並且應當熟悉藥品注冊管理法律、法規和藥品注冊的技術要求。
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Chapter II Application for Drug Registration
| | 第二章 藥品注冊的申請
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Article 7 The applications for drug registration shall include the applications for new drugs, applications for drugs for which there have been already national standards, applications for imported drugs, and supplementary applications thereof. For a domestic applicant, the procedures for filing applications for new drugs and for filing applications for which there have already been national standards shall be followed; for an overseas applicant, the procedures for the application for imported drugs shall be followed.
| | 第七條 藥品注冊申請包括新藥申請、已有國家標准的藥品申請、進口藥品申請和補充申請。境內申請人申請藥品注冊按照新藥申請、已有國家標准藥品申請的程序和要求辦理，境外申請人申請藥品注冊按照進口藥品申請程序和要求辦理。
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Article 8 The “applications for new drugs” shall refer to the applications for the registration of drugs that haven't been marketed within China. If the dosage form or the route of medication of any drugs that have been marketed is changed, or if the range of indications thereof is newly expanded, the said drugs shall be treated as new drugs.
The applications for drugs for which there have already been national standards shall refer to the applications for the registration of the drugs for which the SFDA has promulgated formal standards.
The applications for imported drugs shall refer to the applications for registration of the drugs that are manufactured overseas and marketed in China.
The supplementary applications shall refer to the applications for changing, adding or canceling the originally approved matters or contents after the applications for new drugs for which there have already been national standards or imported drugs have been approved.
| | 第八條 新藥申請，是指未曾在中國境內上市銷售的藥品的注冊申請。已上市藥品改變劑型、改變給藥途徑、增加新適應症的，按照新藥申請管理。
已有國家標准的藥品申請，是指生產國家食品藥品監督管理局已經頒布正式標准的藥品的注冊申請。
進口藥品申請，是指境外生產的藥品在中國境內上市銷售的注冊申請。
補充申請，是指新藥申請、已有國家標准的藥品申請或者進口藥品申請經批准後，改變、增加或取消原批准事項或者內容的注冊申請。
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Article 9 An applicant shall file an application for drug registration with the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government at the location of application, and shall submit relevant materials and drug samples. In the case of an application for registration of imported drugs, the applicant shall file the application with the SFDA.
The applicant shall be responsible for the authenticity of all the contents of the application materials.
| | 第九條 申請藥品注冊，申請人應當向所在地省、自治區、直轄市（食品）藥品監督管理部門提出，並報送有關資料和藥物實樣；進口藥品的注冊申請，應當直接向國家食品藥品監督管理局提出。
申請人應當對申報資料全部內容的真實性負責。
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Article 10 If two or more institutions jointly apply for the registration of a new drug, they shall file an application with the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the drug manufacturer is located. If all the applicants are drug manufacturers, they shall file an application with the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the drug manufacturer of the preparation is located. If none of the applicants is a drug manufacturer, they shall file an application with the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the samples are trial-produced.
| | 第十條 兩個以上單位共同作為新藥申請人的，應當向其中藥品生產企業所在地省、自治區、直轄市（食品）藥品監督管理部門提出申請；申請人均為藥品生產企業的，應當向申請生產制劑的藥品生產企業所在地省、自治區、直轄市（食品）藥品監督管理部門提出申請；申請人均不是藥品生產企業的，應當向樣品試制現場所在地省、自治區、直轄市（食品）藥品監督管理部門提出申請。
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Article 11 For the drug applied for registration or the prescription, techniques or uses of the drug, the applicant shall provide its patent or the patent of any other person in China as well as the explanations on its ownership; if other party holds patent in China, the applicant shall submit a letter stating that the drug will not infringe upon the patent of others.
| | 第十一條 申請人應當對其申請注冊的藥物或者使用的處方、工藝、用途等，提供申請人或者他人在中國的專利及其權屬狀態的說明；他人在中國存在專利的，申請人應當提交對他人的專利不構成侵權的聲明。
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Article 12 Where any dispute arises after the application for drug registration is approved, the parties concerned shall settle the dispute through negotiation by themselves, or through the patent administrative department or the people's court pursuant to relevant laws and regulations.
A patentee may, on the basis of the final ruling made by the patent administrative department or valid judgment affirming infringement as made by the people's court, file with the SFDA for canceling the drug approval document number. Accordingly, the SFDA shall write off the drug approval documents of the infringer.
| | 第十二條 藥品注冊申請批准後發生專利權糾紛的，當事人可以自行協商解決，或者依照有關法律、法規的規定，通過管理專利工作的部門或者人民法院解決。
專利權人可以依據管理專利工作的部門的最終裁決或者人民法院認定構成侵權的生效判決，向國家食品藥品監督管理局申請注銷侵權人的藥品批准文號。國家食品藥品監督管理局據此注銷侵權人的藥品批准證明文件。
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Article 13 As for a drug of which the Chinese patent has been obtained by any other person, an applicant may file a registration application within two years prior to the expiration of the drug patent. The SFDA shall conduct an examination pursuant to these Measures, and, if the applicant meets the relevant conditions, issue to it the drug approval document number, Import Drug License or Pharmaceutical Product License after the patent expires.
| | 第十三條 對他人已獲得中國專利權的藥品，申請人可以在該藥品專利期屆滿前2年內提出注冊申請。國家食品藥品監督管理局按照本辦法予以審查，符合規定的，在專利期滿後核發藥品批准文號、《進口藥品注冊證》或者《醫藥產品注冊證》。
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Article 14 Where a producer or seller, who has obtained a permit to produce or sell an drug containing any new chemical ingredient, submits any undisclosed experimental data or other data obtained by itself, the SFDA shall not, within six years upon granting this permit, approve any other application for using the undisclosed data except for the data acquired individually, unless it is approved by the applicant who has obtained the aforesaid permit.
| | 第十四條 對獲得生產或者銷售含有新型化學成份藥品許可的生產者或者銷售者提交的自行取得且未披露的試驗數據和其他數據，國家食品藥品監督管理局自批准該許可之日起6年內，對未經已獲得許可的申請人同意，使用其未披露數據的申請不予批准。但是申請人提交自行取得數據的除外。
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Chapter III Pre-clinical trial of New Drugs
| | 第三章 藥物的臨床前研究
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Article 15 The pre-clinical trial of new drugs for applying for drug registration shall include synthetic techniques, extraction methods, physical and chemical properties, purity, choice of drug forms, selection of prescriptions, preparation techniques, inspection methods, quality indicators, stability, pharmacology, toxicology, nuclein animal dynamics, etc. As for Chinese traditional medicine preparations, the sources and processing of the original medicine materials, etc. shall also be included; as for biologic products, the sources, quality standards, preservation conditions, biological features, inheritance stability and immunological study of the primary raw materials such as microbial and toxic species, cell line or organism, etc. shall also be included.
| | 第十五條 為申請藥品注冊而進行的藥物臨床前研究，包括藥物的合成工藝、提取方法、理化性質及純度、劑型選擇、處方篩選、制備工藝、檢驗方法、質量指標、穩定性、藥理、毒理、動物藥代動力學研究等。中藥制劑還包括原藥材的來源、加工及炮制等的研究；生物制品還包括菌毒種、細胞株、生物組織等起始原材料的來源、質量標准、保存條件、生物學特征、遺傳穩定性及免疫學的研究等。
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Article 16 The relevant administrative provisions shall be executed in the pre-clinical trial of new drugs, and the Good Laboratory Practice for Nonclinical Laboratory Studies (“GLP”) must be executed in the safety evaluation study.
| | 第十六條 藥物臨床前研究應當執行有關管理規定，其中安全性評價研究必須執行《藥物非臨床研究質量管理規範》。
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Article 17 An institution engaging in drug research and development must have the personnel, site, equipment, instruments and management system that can meet the requirements for clinical trials. The animals, reagents, and raw materials for trials shall conform to the relevant provisions and requirements of the state, and shall ensure the authenticity of all the trial data and materials.
| | 第十七條 從事藥物研究開發的機構必須具有與試驗研究項目相適應的人員、場地、設備、儀器和管理制度；所用試驗動物、試劑和原材料應當符合國家有關規定和要求，並應當保證所有試驗數據和資料的真實性。
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Article 18 As to a separate application for the registration of a drug preparation, the applicant shall have, for the active pharmaceutical ingredients (APIs) used for the study of the drug preparation, the drug approval document number, an Import Drug License or Pharmaceutical Product License, and the APIs must be obtained through legal channels. If, for the APIs, the applicant does not have the drug approval document number, an Import Drug License or Pharmaceutical Product License, such applicant shall be subject to the approval of the SFDA.
| | 第十八條 單獨申請注冊藥物制劑的，研究用原料藥必須具有藥品批准文號、《進口藥品注冊證》或者《醫藥產品注冊證》，該原料藥必須通過合法的途徑獲得。研究用原料藥不具有藥品批准文號、《進口藥品注冊證》或者《醫藥產品注冊證》的，必須經國家食品藥品監督管理局批准。
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Article 19 Where an applicant entrusts any other institution to conduct drug research, separate trial, testing, trial manufacturing or production of samples, etc., it shall enter into a contract with the trustee. The applicant shall be responsible for the authenticity of the drug research data in the application materials.
| | 第十九條 申請人委托其他機構進行藥物研究或者進行單項試驗、檢測、樣品的試制、生產等的，應當與被委托方簽訂合同。申請人應當對申報資料中的藥物研究數據的真實性負責。
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Article 20 If the application materials for drug registration include any drug trial and resarch materials submitted by any overseas drug research institution, there must be attached with the explanations produced by that overseas drug research institution on the projects and the page numbers of the materials provided, and the certifications which can prove that the institution has been legally registered and notarized overseas, and the attached materials may be used as the application materials unless they have been acknowledged by the SFDA. The SFDA shall send personnel to make on-spot inspection where necessary.
| | 第二十條 藥品注冊申報資料中有境外藥物研究機構提供的藥物試驗研究資料的，必須附有境外藥物研究機構出具的其所提供資料的項目、頁碼的情況說明和證明該機構已在境外合法登記的經公證的證明文件，並經國家食品藥品監督管理局認可後，方可作為藥品注冊申請的申報資料。國家食品藥品監督管理局根據審查需要組織進行現場核查。
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Article 21 When inspecting drug research according to needs, the SFDA and the (food) drug regulatory department of a province, autonomous region or municipality directly under the Central Government may request the applicant or the drug research institution undertaking the experiment to conduct a trial again according to the projects, methods and data specified in the application materials, and shall send personnel to oversee the trial on the spot; or an testing institution of medicinal products or other drug research institution may be entrusted to make an experiment again.
| | 第二十一條 國家食品藥品監督管理局和省、自治區、直轄市（食品）藥品監督管理部門根據需要對研究情況進行核查時，可以要求申請人或者承擔試驗的藥物研究機構按照其申報資料的項目、方法和數據進行重複試驗，並組織對試驗過程進行現場核查；也可以委托藥品檢驗所或者其他藥物研究機構進行重複試驗。
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Article 22 The pre-clinical trial of new drugs shall be conducted by referring to the relevant technical guiding principles promulgated by the SFDA. Where an applicant adopts other evaluation methods and techniques in the trials, it shall submit the materials that can prove their scientificalness.
| | 第二十二條 藥物臨床前研究應當參照國家食品藥品監督管理局發布的有關技術指導原則進行。申請人采用其他評價方法和技術進行試驗的，應當提交證明其科學性的資料。
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Chapter IV. Clinical Trials of Drugs
| | 第四章 藥物的臨床試驗
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Section 1 Basic Requirements
| | 第一節 基本要求
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Article 23 The clinical trial of drugs (including bioequivalence study) shall be subject to the approval of the SFDA and shall follow the Good Clinical Practice (GCP).
| | 第二十三條 藥物的臨床試驗（包括生物等效性試驗），必須經過國家食品藥品監督管理局批准；必須執行《藥物臨床試驗質量管理規範》。
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Article 24 An applicant shall conduct clinical trials when applying for the registration of a new drug.
The clinical trials are classified into four phases: I, II, III and IV. Before a new drug is approved for marketing, phases I, II, and III clinical trials shall be conducted. Under certain circumstances, the applicant may, upon approval, only conduct phases II and III clinical trials or only phase III clinical trials.
The phase I clinical trials: the preliminary trials on clinical pharmacology and human body safety evaluation, which aim to observe the degree of tolerance of human body against the new drug and the drug dynamics, and provide the basis for working out the dosage regimen.
The phase II clinical trials: the preliminary evaluation of the therapeutic action, which aim to preliminarily evaluate the therapeutic action and safety of the drug on the target patients with the applicable disease, and also to provide the basis for the determination of study design and dosage regimen for the clinical trial in phase III. Various methods may be employed for the study design of this phase in light of the specific study purpose, including the randomized controlled trial.
The phase III clinical trials: the confirmation phase of the therapeutic action, which aim to further verify the therapeutic action and safety of the drug on the target patient with the applicable disease, to evaluate the relationship between interest and risk, and to eventually provide adequate basis for the examination of the drug registration application. Generally, the trials shall be randomized blind controlled trials (blind RCTs) with sufficient samples.
The phase IV clinical trials: the phase of applied research conducted by the applicant independently after the marketing of a new drug, which aims to examine the curative effect of the drug and the adverse reactions when it is widely used, to evaluate the relationship between interest and risk when the drug is used in ordinary or special groups, and to improve the dosage of administration, etc.
| | 第二十四條 申請新藥注冊，應當進行臨床試驗。
臨床試驗分為Ⅰ、Ⅱ、Ⅲ、Ⅳ期。新藥在批准上市前，應當進行Ⅰ、Ⅱ、Ⅲ期臨床試驗。經批准後，有些情況下可僅進行Ⅱ期和Ⅲ期臨床試驗或者僅進行Ⅲ期臨床試驗。
Ⅰ期臨床試驗：初步的臨床藥理學及人體安全性評價試驗。觀察人體對于新藥的耐受程度和藥代動力學，為制定給藥方案提供依據。
Ⅱ期臨床試驗：治療作用初步評價階段。其目的是初步評價藥物對目標適應症患者的治療作用和安全性，也包括為Ⅲ期臨床試驗研究設計和給藥劑量方案的確定提供依據。此階段的研究設計可以根據具體的研究目的，采用多種形式，包括隨機盲法對照臨床試驗。
Ⅲ期臨床試驗：治療作用確證階段。其目的是進一步驗證藥物對目標適應症患者的治療作用和安全性，評價利益與風險關系，最終為藥物注冊申請的審查提供充分的依據。試驗一般應為具有足夠樣本量的隨機盲法對照試驗。
Ⅳ期臨床試驗：新藥上市後由申請人進行的應用研究階段。其目的是考察在廣泛使用條件下的藥物的療效和不良反應、評價在普通或者特殊人群中使用的利益與風險關系以及改進給藥劑量等。
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Article 25 Generally speaking, it is not required to conduct any clinical trial for the registration of drugs for which there have been already national standards. Among those which require a clinical trial, a bioequivalence study shall be conducted for chemical drugs. For a drug whose quality needs to be controlled by techniques and standards, clinical trials shall be conducted. In a supplementary application, the applicant shall conduct clinical trials if new indications are added for any drug already on the market or if the manufacturing techniques of the drug are altered significantly.
The bioequivalence study is, under the same testing conditions, to compare the statistical disparities of the absorption extent and speed of the active substances of the identical dosage or of different dosages of the same drug in the human body through the approach of bio-availability study and by considering the parameters of drug dynamics as the indicators.
| | 第二十五條 申請已有國家標准的藥品注冊，一般不需要進行臨床試驗；需要進行臨床試驗的，化學藥品一般進行生物等效性試驗；需要用工藝和標准控制藥品質量的藥品，應當進行臨床試驗。在補充申請中，已上市藥品生產工藝等有重大變化或者中藥增加新的功能主治的，應當進行臨床試驗。
生物等效性試驗，是指用生物利用度研究的方法，以藥代動力學參數為指標，比較同一種藥物的相同或者不同劑型的制劑，在相同的試驗條件下，其活性成分吸收程度和速度有無統計學差異的人體試驗。
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Article 26 The number of subjects in drug clinical trials shall be in line with the purpose of the drug clinical trials, shall meet the relevant statistical requirements and shall not be less than the minimum number of subjects for clinical trials as specified in these Measures. As for a rare disease, special disease or any other circumstance where it is needed to reduce the subjects of clinical trials or to exempt clinical trials, the examination and approval of the SFDA is required.
| | 第二十六條 藥物臨床試驗的受試例數應當符合臨床試驗的目的和相關統計學的要求，並且不得少于本辦法所規定的最低臨床試驗病例數。罕見病、特殊病種及其他情況，要求減少臨床試驗病例數或者免做臨床試驗的，必須經國家食品藥品監督管理局審查批准。
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Article 27 With respect to the bacteria or other special drugs prepared during the phase of selecting bacteria or virus species, if it is unable to evaluate the curative effect thereof due to lack of suitable animal model and laboratory, the applicant may apply for clinical trial with the SFDA on the precondition that the safety of the subject is secured.
| | 第二十七條 在菌毒種選種階段制備的疫苗或者其他特殊藥物，確無合適的動物模型且試驗室無法評價其療效的，在保證受試者安全的前提下，可以向國家食品藥品監督管理局申請進行臨床試驗。
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Section 2 Requirements Before Trial
| | 第二節 實施前的要求
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Article 28 After a drug clinical trial has been approved, the applicant shall select, from the institutions qualified for drug clinical trials, an institution to undertake the drug clinical trial, decide through consultation the institution responsible for the clinical trial, the major investigators and the institutions participating in the clinical trial.
| | 第二十八條 藥物臨床試驗批准後，申請人應當從具有藥物臨床試驗資格的機構中，選擇承擔藥物臨床試驗的機構，商定臨床試驗的負責單位、主要研究者及臨床試驗參加單位。
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Article 29 The applicant shall conclude a clinical trial contract with the selected institution responsible for and the institutions participating in the clinical trial, provide the investigators with manuals, and together with the investigators, design and perfect the clinical trial protocol by referring to relevant technical guiding principles.
The clinical trial protocol shall be subject to the examination of the ethic committee of the clinical trial institution.
| | 第二十九條 申請人應當與選定的臨床試驗負責單位和參加單位簽訂臨床試驗合同，提供研究者手冊，參照有關技術指導原則與研究者共同設計和完善臨床試驗方案。
臨床試驗方案應當提請臨床試驗機構倫理委員會進行審查。
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Article 30 The applicant shall provide the selected clinical trial institutions with investigational drugs and control drugs (except for clinical trials in phase IV) free of charge, to which it shall attach a sample inspection report, and bear the expenses needed for clinical trials.
| | 第三十條 申請人應當向選定的臨床試驗單位免費提供臨床試驗用藥物和對照用藥品（Ⅳ期臨床試驗除外），並附樣品檢驗報告書；臨床試驗所需要的費用由申請人承擔。
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Article 31 Investigational drugs shall be produced and prepared in workshops meeting the conditions as provided for in the Good Manufacturing Practice (“GMP”). The process of production and preparation shall strictly follow the GMP.
The SFDA or the entrusted (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government may conduct on-the-spot checks where it so requires.
| | 第三十一條 臨床試驗用藥物應當在符合《藥品生產質量管理規範》的車間制備。制備過程應當嚴格執行《藥品生產質量管理規範》的要求。
國家食品藥品監督管理局或者省、自治區、直轄市（食品）藥品監督管理部門可以根據審查需要進行現場核查。
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Article 32 An applicant may inspect investigational drugs by itself according to the drug standards determined by the SFDA, or entrust an institute to do the drug control as specified in Articles 147 and 148 of these Measures to conduct the inspection. The drugs shall not be used in clinical trials unless they have passed the drug inspection.
The SFDA may designate a testing institution of medicinal products to make a selective inspection over investigational drugs.
The vaccine products, blood products, and other biological products as well as overseas-manufactured drugs used for clinical trials as provided for by the SFDA, shall be subject to the inspection by the institutes for drug control designated by the SFDA. They shall not be used in clinical trials unless they have passed the aforesaid drug inspection.
The applicant shall be liable for the quality of investigational drugs.
| | 第三十二條 申請人可以按照國家食品藥品監督管理局審定的藥品標准自行檢驗臨床試驗用藥物，也可以委托本辦法第一百四十七條和第一百四十八條確定的藥品檢驗所進行檢驗。臨床試驗用藥物經檢驗合格後方可用于臨床試驗。
國家食品藥品監督管理局可以指定藥品檢驗所對臨床試驗用的藥物進行抽查檢驗。
疫苗類制品、血液制品、國家食品藥品監督管理局規定的其他生物制品以及境外生產的臨床試驗用藥物，必須經國家食品藥品監督管理局指定的藥品檢驗所檢驗合格後方可用于臨床試驗。
申請人對臨床試驗用藥物的質量負責。
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Article 33 An applicant shall, before carrying out the clinical trials of a drug, submit the clinical trial protocol and the names of the principal investigators of the institution responsible for the clinical trial, the list of the participating institutions and the investigators thereof, the letter of approval of the ethics committee, the sample of the letter of consent and knowledge to the SFDA for record, and shall submit copies of the aforesaid materials to the (food) drug regulatory departments of provinces, autonomous regions or municipalities directly under the Central Government where the clinical trial institutions are located and where the application is accepted.
| | 第三十三條 申請人在藥物臨床試驗實施前，應當將已確定的臨床試驗方案和臨床試驗負責單位的主要研究者姓名、參加研究單位及其研究者名單、倫理委員會審核同意書、知情同意書樣本等報送國家食品藥品監督管理局備案，並抄送臨床試驗單位所在地和受理該申請的省、自治區、直轄市（食品）藥品監督管理部門。
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Section 3 Administration of Clinical Trials
| | 第三節 臨床試驗的管理
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Article 34 In the course of clinical trials of a drug, the applicant shall appoint a supervisor to supervise the course of trials in pursuance of the GCP.
| | 第三十四條 藥物臨床試驗過程中，申請人應當任命監查員，按照《藥物臨床試驗質量管理規範》監督試驗過程。
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Article 35 If the applicant finds out that any clinical investigator violates the relevant provisions or fails to carry out the clinical trial protocol, it shall urge the investigator to make corrections; if the circumstances are serious, it may demand suspension or termination of the clinical trials, and shall report the relevant situation to the SFDA and the (food) drug regulatory department of the relevant province, autonomous region or municipality directly under the Central Government.
| | 第三十五條 申請人發現研究者違反有關規定或者未按照臨床試驗方案執行的，應當督促其改正；情節嚴重的，可以要求暫停臨床試驗，或者終止臨床試驗，並將情況報告國家食品藥品監督管理局和有關省、自治區、直轄市（食品）藥品監督管理部門。
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Article 36 After finishing each phase of clinical trials, the applicant shall submit a clinical trial and statistical analysis report to the SFDA and to the (food) drug regulatory department of the relevant province, autonomous region or municipality directly under the Central Government. Moreover, after it finishes the clinical trials in phase IV, it shall submit a summary report to the SFDA.
If the period of clinical trial exceeds one year, the applicant shall submit a report on the progress of the clinical trial to the SFDA and the (food) drug regulatory department of the relevant province, autonomous region or municipality directly under the Central Government every year as of the date of approval.
| | 第三十六條 申請人完成每期臨床試驗後，應當向國家食品藥品監督管理局和有關省、自治區、直轄市（食品）藥品監督管理部門提交臨床試驗和統計分析報告。完成Ⅳ期臨床試驗後，還應當向國家食品藥品監督管理局提交總結報告。
臨床試驗時間超過1年的，申請人應當自批准之日起每年向國家食品藥品監督管理局和有關省、自治區、直轄市（食品）藥品監督管理部門提交臨床試驗進展報告。
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Article 37 The clinical trials of a drug shall be carried out within three years from the date of approval. If any clinical trials cannot be carried out within the time limit so prescribed, the original certifications of approval shall be invalidated automatically. A new application shall be filed if it is still needed to carry out clinical trials.
| | 第三十七條 藥物臨床試驗被批准後應當在3年內實施。逾期未實施的，原批准證明文件自行廢止；仍需進行臨床試驗的，應當重新申請。
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Article 38 The institutions and personnel participating in the clinical trials shall be familiar with the nature, functions, curative effect and safety of investigational drugs, shall understand the responsibilities and obligations of clinical investigators, shall obtain the letter of consent and knowledge voluntarily signed by the subject, and shall make clinical trial records genuinely, accurately, completely, timely and truthfully.
| | 第三十八條 參加臨床試驗的單位及人員應當熟悉供臨床試驗用藥物的性質、作用、療效和安全性；了解研究者的責任和義務；獲得由受試者或者其法定代理人自願簽署的知情同意書；真實、准確、完整、及時、合法地做好臨床試驗記錄。
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Article 39 If any applicant violates the GCP or requests for changing the data or conclusion of the trial, the institutions and personnel participating in the clinical trial shall report it to the (food) drug regulatory department of the relevant province, autonomous region, or municipality directly under the Central Government and the SFDA.
| | 第三十九條 參加臨床試驗的單位及研究者，對申請人違反《藥物臨床試驗質量管理規範》或者要求改變試驗數據、結論的，應當向所在地省、自治區、直轄市（食品）藥品監督管理部門和國家食品藥品監督管理局報告。
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Article 40 The institutions undertaking the clinical trials and the clinical investigators are obliged to take necessary measures to guarantee the safety of the subject.
The clinical investigators shall pay close attention to the occurrence of any adverse event involving investigational drugs, take proper treating measures for the subject without delay, and shall make records.
If any serious adverse event occurs in the course of a clinical trial, the investigators shall, within 24 hours, report it to the (food) drug regulatory department of the relevant province, autonomous region or municipality directly under the Central Government and the SFDA, and shall timely report it to the ethics committee.
| | 第四十條 承擔臨床試驗的單位和研究者，有義務采取必要的措施，保障受試者的安全。
研究者應當密切注意臨床試驗用藥物不良事件的發生，及時對受試者采取適當的處理措施，並記錄在案。
臨床試驗過程中發生嚴重不良事件的，研究者應當在24小時內報告有關省、自治區、直轄市（食品）藥品監督管理部門和國家食品藥品監督管理局及申請人，並及時向倫理委員會報告。
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Article 41 The SFDA and the (food) drug regulatory departments of relevant provinces, autonomous regions and municipalities directly under the Central Government shall conduct supervision and inspection over the clinical trials that have been approved.
| | 第四十一條 對已批准的臨床試驗，國家食品藥品監督管理局和省、自治區、直轄市（食品）藥品監督管理部門應當進行監督檢查。
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Article 42 If any of the following cases occurs in the course of a clinical trial, the SFDA may request the applicant to modify the clinical trial protocol, or to suspend or terminate the clinical trial:
| | 第四十二條 臨床試驗期間發生下列情形之一的，國家食品藥品監督管理局可以責令申請人修改臨床試驗方案、暫停或者終止臨床試驗：
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(1) The ethics committee fails to fulfill its duties;
| | （一）倫理委員會未履行職責的；
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(2) The safety of the subjects can't be effectively guaranteed;
| | （二）不能有效保證受試者安全的；
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(3) Serious adverse event is not reported within the prescribed time limit;
| | （三）未按照規定時限報告嚴重不良事件的；
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(4) No report on the progress of clinical trial is submitted in a timely and truthfully manner;
| | （四）未及時、如實報送臨床試驗進展報告的；
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(5) The approved clinical trial fails to produce evaluation results within two years after the scheduled end of the study;
| | （五）已批准的臨床試驗超過原預定研究結束時間2年仍未取得可評價結果的；
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(6) There is, already, evidence that investigational drugs are ineffective;
| | （六）已有證據證明臨床試驗用藥物無效的；
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(7) Investigational drugs have quality problems;
| | （七）臨床試驗用藥物出現質量問題的；
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(8) Frauds are committed in the clinical trial; or
| | （八）臨床試驗中弄虛作假的；
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(9) Other circumstances in violation of the GCP.
| | （九）存在違反《藥物臨床試驗質量管理規範》的其他情形的。
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Article 43 Where the applicant or the clinical trial institution is ordered by the SFDA to modify the clinical trial protocol, to suspend or terminate the clinical trial, it shall comply with such order.
| | 第四十三條 國家食品藥品監督管理局責令修改臨床試驗方案、暫停或者終止臨床試驗的，申請人或者臨床試驗單位應當遵照執行。
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Article 44 If a wide range of unanticipated adverse reactions or serious adverse events occur in a clinical trial, or there has been evidence that investigational drugs have serious quality problems, the SFDA or the (food) drug regulatory department of the relevant province, autonomous region or municipality directly under the Central Government may take urgent measures and order the applicant and the clinical trial institution to suspend or terminate the clinical trial, in which case the applicant and the clinical trial institution shall stop the clinical trial immediately.
| | 第四十四條 臨床試驗中出現大範圍、非預期的不良反應或者嚴重不良事件或者有證據證明臨床試驗用藥物存在嚴重質量問題時，國家食品藥品監督管理局或者省、自治區、直轄市（食品）藥品監督管理部門可以采取緊急控制措施，責令暫停或者終止臨床試驗，申請人和臨床試驗單位必須立即停止臨床試驗。
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Article 45 Clinical investigators shall be responsible for the use of drugs for clinical trial use. Investigators shall ensure that all the drugs for clinical trials are only used on the subjects, and the drug usage and dosage shall conform to the clinical trial protocol. No investigator may use investigational drugs on any person not participating in the clinical trials. Investigational drugs shall not be sold.
| | 第四十五條 臨床試驗用藥物的使用由研究者負責。研究者必須保證所有臨床試驗用藥物僅用于該臨床試驗的受試者，其用法與用量應當符合臨床試驗方案。研究者不得把試驗用藥物轉用于任何非臨床試驗參加者。臨床試驗用藥物不得銷售。
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Article 46 If any overseas applicant wishes to conduct an international multi-center clinical trial of a drug, it shall file an application with the SFDA pursuant to these Measures and meet the requirements of the following provisions:
| | 第四十六條 境外申請人在中國進行國際多中心藥物臨床試驗的，應當按照本辦法向國家食品藥品監督管理局提出申請，並按下列要求辦理：
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(1) Investigational drugs shall be those that have been registered overseas or have entered into the phase II or III clinical trials. The SFDA shall not accept any application filed by an overseas applicant for international multi-center clinical trial of the new preventive vaccine drugs that have not yet been registered overseas;
| | （一）臨床試驗用藥物應當是已在境外注冊的藥品或者已進入Ⅱ期或者Ⅲ期臨床試驗的藥物；國家食品藥品監督管理局不受理境外申請人提出的尚未在境外注冊的預防用疫苗類藥物的國際多中心藥物臨床試驗申請；
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(2) The SFDA may, when granting approval for conducting an international multi-center clinical trial of any drug, request the applicant to carry out Phase I clinical trials in China where it so requires;
| | （二）國家食品藥品監督管理局在批准進行國際多中心藥物臨床試驗的同時，可以根據需要，要求申請人在中國首先進行Ⅰ期臨床試驗；
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(3) When conducting an international multi-center clinical trial of any drug in China, if any serious adverse reactions and unanticipated adverse reactions relating to such drugs are found in any country, the applicant shall timely report to the SFDA pursuant to relevant provisions;
| | （三）在中國進行國際多中心藥物臨床試驗時，在任何國家發現與該藥物有關的嚴重不良反應和非預期不良反應，申請人應當按照有關規定及時報告國家食品藥品監督管理局；
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(4) After a clinical trial is ended, the applicant shall submit a complete clinical trial report to the SFDA;
| | （四）臨床試驗結束後，申請人應當將完整的臨床試驗報告報送國家食品藥品監督管理局；
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(5)If the data obtained in an international multi-center clinical trial of drugs is used in the application for drug registration in China, the provisions relating to clinical trial provided for in the Medicinal Product Administration Law, the Implementation Regulations, and these Measures shall be met, and the applicant shall submit all the study materials of the international multi-center clinical trial.
| | （五）國際多中心藥物臨床試驗取得的數據用于在中國進行藥品注冊申請的，必須符合本辦法有關臨床試驗的規定，申請人必須同時提交國際多中心臨床試驗的全部研究資料。
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Chapter V. Application and Examination & Approval of New Drugs
| | 第五章 新藥的申報與審批
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Section 1 Basic Requirements
| | 第一節 基本要求
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Article 47 The materials submitted for the registration of new drugs shall be complete and normative, and the data must be true and reliable. The documentary materials quoted shall be marked with the title of the article, title of the publication, as well as the volume, issue and page number, etc. The documentary materials not publicly published shall be accompanied with the certification documents about the owners' permit to use. The materials in foreign languages shall be accompanied with Chinese translations pursuant to the requirements.
| | 第四十七條 申請新藥注冊所報送的資料應當完整、規範，數據真實、可靠；引用文獻資料應當注明著作名稱、刊物名稱及卷、期、頁等；未公開發表的文獻資料應當提供資料所有者許可使用的證明文件。外文資料應當按照要求提供中文譯本。
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Article 48 With respect to the applications for the following new drugs, the SFDA shall allow a fast track for examination and approval:
| | 第四十八條 國家食品藥品監督管理局對下列申請可以實行快速審批：
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(1)The effective components extracted from the plants, animals, minerals and other materials that haven't been marketed within China and the preparations thereof, the newly found drug materials and preparations thereof;
| | （一）未在國內上市銷售的從植物、動物、礦物等物質中提取的有效成份及其制劑，新發現的藥材及其制劑；
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(2)The chemical APIs as well as the preparations and biological products thereof that haven't been approved for marketing at home and abroad;
| | （二）未在國內外獲准上市的化學原料藥及其制劑、生物制品；
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(3)The new drugs intended for the treatment of AIDS, malignant tumours and rare diseases etc;
| | （三）用于治療艾滋病、惡性腫瘤、罕見病等的新藥；
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(4)New drugs treating the diseases that can't be cured by effective means yet; and
| | （四）治療尚無有效治療手段的疾病的新藥；
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(5)The drugs badly needed in an emergent accident.
| | （五）突發事件應急所必需的藥品。
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Article 49 The (food) drug regulatory department of a province, autonomous region and municipality directly under the Central Government shall, after receiving an application for registration of any new drug listed in Article 48 of these Measures, conduct examination and give opinions on whether or not that application meets the conditions for fast-track examination and approval. The SFDA shall decide whether or not to allow the fast-track examination and approval after it receives the materials and opinions submitted by the aforesaid (food) drug regulatory department of a province, autonomous region and municipality directly under the Central Government.
| | 第四十九條 省、自治區、直轄市（食品）藥品監督管理部門在受理本辦法第四十八條所列藥品的注冊申請後，應當就該申請是否符合快速審批的條件進行審查並提出意見。國家食品藥品監督管理局收到省、自治區、直轄市（食品）藥品監督管理部門報送的資料和意見後，確定是否對該申請實行快速審批。
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Article 50 With regard to a new drug jointly developed by several institutions, the application for registration of the new drug may be filed by one of these institutions and no repetitive application may be filed by any other institution. Except for the drugs listed in Items (1) and (2) of Article 48 of these Measures, each category of such drug may, after the application for registration of the new drug is approved, be manufactured by one institution only, and different specifications of the same category may not be manufactured by different institutions.
With regard to the technologies of a new drug, it is not allowed to incite different applicants to file their respective application, or to file repetitive applications in any disguised form. Where necessary, the SFDA and the relevant (food) drug regulatory department of the province, autonomous region and municipality directly under the Central Government may verify the relevant information. If it is found true upon verification, the repetitive application shall be rejected. Any repetitive application which have been accepted shall be disapproved.
| | 第五十條 多個單位聯合研制的新藥，應當由其中的一個單位申請注冊，其他單位不得重複申請；需要聯合申請注冊的，應當共同署名作為該新藥的申請人。除本辦法第四十八條（一）、（二）規定的藥物外，新藥申請獲得批准後每個品種只能由一個單位生產，同一品種的不同規格不得分由不同單位生產。
同一新藥技術不得指使不同的申請人分別申報或者變相重複申報，國家食品藥品監督管理局和省、自治區、直轄市（食品）藥品監督管理部門可以根據審查需要組織對相關情況進行核查。核查屬實的，不予受理，已經受理的，予以退審。
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Article 51 In the examination process of a new drug, the registration category of and the technical requirements for the new drug shall remain unchanged even if the preparation of identical active ingredients is permitted to enter the overseas market.
In the examination process of a new drug, the registration category of and the technical requirements for the new drug shall remain unchanged even if the preparation of identical active ingredients applied by a domestic drug production enterprise is allowed to enter the market of China.
| | 第五十一條 在新藥審批期間，新藥的注冊分類和技術要求不因相同活性成分的制劑在國外獲准上市而發生變化。
在新藥審批期間，其注冊分類和技術要求不因國內藥品生產企業申報的相同活性成分的制劑在我國獲准上市而發生變化。
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Section 2 Examination & Approval of Clinical Trials of New Drugs
| | 第二節 新藥臨床試驗的審批
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Article 52 After finishing the pre-clinical trials of new drugs, an applicant shall fill in the Application Form for Drug Registration, and faithfully submit the relevant materials and drug samples to the local (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government.
| | 第五十二條 申請人完成臨床前研究後，填寫《藥品注冊申請表》，向所在地省、自治區、直轄市（食品）藥品監督管理部門如實報送有關資料和藥物實樣。
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Article 53 The (food) drug regulatory departments of the provinces, autonomous regions or municipalities directly under the Central Government shall conduct formal review of application materials, and accept them while giving an application acceptance notice if the application materials meet relevant requirements. Otherwise, such authorities shall give the applicant an application rejection notice and explain the reason for rejection.
Any (food) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall, within five days from the day upon its acceptance of an application, organize an on-spot inspection over the drug research and production information as well as the conditions thereof, take 1-3 samples for inspection use, and send a notice about the registration inspection to the designated testing institution of medicinal products. The (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall, within the prescribed time limit, submit the examination opinions, inspection report, and application materials to the SFDA, and notify the applicant.
| | 第五十三條 省、自治區、直轄市（食品）藥品監督管理部門應當對申報資料進行形式審查，符合要求的予以受理，出具藥品注冊申請受理通知書；不符合要求的不予受理，出具藥品注冊申請不予受理通知書，並說明理由。
省、自治區、直轄市（食品）藥品監督管理部門應當自申請受理之日起5日內組織對藥物研制情況及條件進行現場核查；抽取1至3個生產批號的檢驗用樣品，並向藥品檢驗所發出注冊檢驗通知。省、自治區、直轄市（食品）藥品監督管理部門應當在規定的時限內將審查意見、核查報告及申報資料報送國家食品藥品監督管理局，並通知申請人。
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Article 54 The testing institution of medicinal products receiving the notice about registration inspection shall check and test the above-mentioned samples, verify the drug standards of the application, and submit the inspection report and verification opinions to the SFDA within the prescribed time limit, and simultaneously send copies of those documents to the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government that sent it the inspection notice, and to the applicant as well.
| | 第五十四條 接到注冊檢驗通知的藥品檢驗所應當對抽取的樣品進行檢驗，對申報的藥品標准進行複核，並在規定的時限內將藥品注冊檢驗報告和複核意見報送國家食品藥品監督管理局，同時抄送通知其檢驗的省、自治區、直轄市（食品）藥品監督管理部門和申請人。
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Article 55 The SFDA shall, upon the receipt of application materials, organize technicians of pharmacology, iatrology and other subjects to conduct technical evaluation of the new drug. If the application materials are found to meet pertinent provisions, the SFDA shall issue to the applicant an Approval of Drug Clinical Trial; if, however, the application materials are found to violate pertinent provisions, the SFDA shall give a Notice of Examination Opinions and explain the reasons therefore.
| | 第五十五條 國家食品藥品監督管理局收到申報資料後，應當組織藥學、醫學和其他學科技術人員，對新藥進行技術審評，必要時可以要求申請人補充資料、提供藥物實樣。認為符合規定的，發給《藥物臨床試驗批件》；認為不符合規定的，發給《審批意見通知件》，並說明理由。
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Article 56 If, after the applicant receives the verification opinions, the testing institution of medicinal products considers that the drug standards applied for are unable to control the quality, the applicant may withdraw the new drug application. If the applicant fails to withdraw its application and if the SFDA considers that the drug standards are really unable to control the quality, the application shall be disapproved.
| | 第五十六條 申請人收到複核意見後，對于藥品檢驗所認為申報的藥品標准無法控制質量的，可以提出將該新藥申請撤回。申請人未提出撤回申請，國家食品藥品監督管理局經審核認為藥品標准確實無法控制質量的，應當予以退審。
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Article 57 If, upon inspection, any sample doesn't conform to the drug standards for which the applicant applies, the SFDA shall disapprove the new drug application.
| | 第五十七條 樣品經檢驗，發現不符合申請人申報的藥品標准的，國家食品藥品監督管理局在核實後對新藥申請予以退審。
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Article 58 During the period of the SFDA's examining an application for registration of a drug, except for the creative ingredients of the drug or new discoveries involving the drug safety and the supplementary materials as required, the applicant shall generally not supplement any new technical materials. If the applicant insists that it must supplement some technical materials, it shall withdraw its drug registration application and shall file a new one after it has prepared a complete set of materials.
| | 第五十八條 在國家食品藥品監督管理局對藥品注冊申請進行審查期間，除創新的藥物成份或者涉及藥品安全性的新發現，以及要求補充的資料外，申請人一般不得自行補充新的技術資料。申請人認為必須補充新的技術資料的，應當撤回其藥品注冊申請，資料補充完畢後重新申報。
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Article 59 Where a new drug application is withdrawn by the applicant on its own initiative or disapproved by the SFDA, if the applicant meets the conditions for application as provided for in the present Provisions after it conducts a new study, and there is no identical product entering into the new drug monitoring period, it may file a new application and go through the original application formalities.
| | 第五十九條 自行撤回或者被退審的新藥申請，申請人在重新進行研究後，符合本辦法有關規定且尚無同品種進入新藥監測期的，申請人可以重新申報，並按照原申請程序辦理。
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Section 3 Manufacturing Examination & Approval of New Drugs
| | 第三節 新藥生產的審批
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Article 60 An applicant shall fill out an Application Form for Drug Registration upon the completion of clinical trials of a drug, and submit clinical trial materials and other materials to be modified and supplemented to the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located, alongside a letter stating the basis and reasons in details, while sending the raw materials of the standard products to the the State Administration for the Inspection and Testing of Pharmaceuticals and Biological Products.
| | 第六十條 申請人完成藥物臨床試驗後，應當填寫《藥品注冊申請表》，向所在地省、自治區、直轄市（食品）藥品監督管理部門報送臨床試驗資料及其他變更和補充的資料，並詳細說明依據和理由，同時向中國藥品生物制品檢定所報送制備標准品的原材料。
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Article 61 The (food) drug regulatory departments of provinces, autonomous regions or municipalities directly under the Central Government shall conduct a formal examination over application materials. Where the application materials are found to meet relevant requirements upon examination, a drug regulatory department shall accept them and issue to the applicant a notification on acceptance of the drug registration application. If, however, the application materials are found not to meet relevant requirements, the drug regulatory department shall reject them and issue to the applicant a notice of rejection on the drug registration application and explain the reasons therefore.
| | 第六十一條 省、自治區、直轄市（食品）藥品監督管理部門應當對申報資料進行形式審查，認為符合要求的，予以受理，出具藥品注冊申請受理通知書；認為不符合要求的，不予受理，出具藥品注冊申請不予受理通知書，並說明理由。
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Article 62 The (food) drug regulatory departments of provinces, autonomous regions or municipalities directly under the Central Government shall, within five days from the day when they accept an application, organize on-the-spot inspection over the manufacturing process and conditions, take samples from the products of successive three production batch numbers, and send a registration inspection notice to the designated testing institution of medicinal products. Then, the (food) drug regulatory departments shall submit the inspection opinions, investigation reports, and application materials to the SFDA within the prescribed time limit, and notify the applicant.
| | 第六十二條 省、自治區、直轄市（食品）藥品監督管理部門應當自申請受理之日起5日內組織對生產情況和條件進行現場核查；抽取連續3個生產批號的樣品，並向藥品檢驗所發出注冊檢驗通知。省、自治區、直轄市（食品）藥品監督管理部門應當在規定的時限內將審查意見、核查報告及申報資料報送國家食品藥品監督管理局，並通知申請人。
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Article 63 The samples so taken from the products of successive three batch numbers needed for the application of a new drug shall be manufactured in the workshops with the certificate of the GMP. For new drug manufacturers, new drug workshops or dosage forms of a drug manufacturer, the manufacturing process of samples thereof must conform to the requirements of the GMP.
| | 第六十三條 新藥申請所需的連續3個生產批號的樣品，應當在取得《藥品生產質量管理規範》認證證書的車間生產；新開辦藥品生產企業、藥品生產企業新建藥品生產車間或者新增生產劑型的，其樣品的生產過程必須符合《藥品生產質量管理規範》的要求。
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Article 64 A testing institution of medicinal products shall, upon receipt of a registration inspection notice, make inspection over the samples so taken, and submit an inspection report to the SFDA within the prescribed time limit, with copies sent to the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the inspection is conducted, and to the applicant.
| | 第六十四條 接到注冊檢驗通知的藥品檢驗所應當對抽取的樣品進行檢驗，並在規定的時限內將藥品注冊檢驗報告報送國家食品藥品監督管理局，同時抄送通知其檢驗的省、自治區、直轄市（食品）藥品監督管理部門和申請人。
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Article 65 The SFDA shall, after receiving application materials, make an overall review of the materials, and may require the applicant to make supplements when necessary. If the application materials are found to meet relevant requirements upon examination, the SFDA shall issue the applicant an Approval of Drug Registration and a New Drug Certificate. If the applicant holds a Manufacturing Permit for Medicinal Products and has the conditions for drug manufacture, the SFDA may simultaneously issue to the applicant the drug approval document number. If the application materials are found not to meet relevant requirements upon examination, the SFDA shall issue to the applicant a Notice on Examination Opinions and explain the reasons therefore.
| | 第六十五條 國家食品藥品監督管理局收到申報資料後，應當進行全面審評，必要時可以要求申請人補充資料。認為符合規定的，發給《藥品注冊批件》和新藥證書；申請人已持有《藥品生產許可證》並具備該藥品相應生產條件的，可以同時發給藥品批准文號。認為不符合規定的，發給《審批意見通知件》，並說明理由。
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Article 66 Dispensatories shall be offered by the applicant, which, however, shall be subject to the verification and approval of the SFDA according to the application materials submitted by the applicant. When an approval is granted to the drug application, the dispensatory and registration standard shall be announced simultaneously. The applicant shall be responsible for the correctness and accuracy of the dispensatory.
A drug manufacturer shall track the safety and effectiveness of the drug after it enters into the market, and file an application for modifying the dispensatory without delay if necessary.
Dispensatories shall be printed and produced according to the content as approved and the format as required by the SFDA.
| | 第六十六條 藥品說明書由申請人提出，國家食品藥品監督管理局根據申請人申報的資料對藥品說明書予以核准，並在批准藥品申請時將藥品說明書與該藥品的注冊標准同時予以發布。申請人對藥品說明書正確性與准確性負責。
藥品生產企業應當跟蹤藥品上市後的安全性、有效性情況，必要時應當及時提出修改藥品說明書的申請。
藥品說明書必須按照國家食品藥品監督管理局核准的內容和規定的格式印制。
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Article 67 Where, to apply for a new drug, the samples from the products of three successive batch numbers are manufactured in the workshops with the Manufacturing Permit for Medicinal Products and the GMP, they may be marketed within their effective periods after passing the inspection conducted by the testing institution of medicinal products as designated by the SFDA and obtaining the drug approval document number in accordance with Articles 147 and 148 of these Measures.
| | 第六十七條 為申請新藥所生產的連續3個生產批號的樣品，在持有《藥品生產許可證》和《藥品生產質量管理規範》認證證書的車間生產的，經依據本辦法第一百四十七條和第一百四十八條確定的藥品檢驗所檢驗合格並取得藥品批准文號後，可以在藥品的有效期內上市銷售。
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Section 4 Administration of the Monitoring Periods of New Drugs
| | 第四節 新藥監測期的管理
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Article 68 With a view to protecting public health, the SFDA may set forth monitoring periods for new drugs approved to be manufactured, to continually monitor the safety of those new drugs.
The SFDA will not approve other enterprises to manufacture or import new drugs within the monitoring periods.
| | 第六十八條 國家食品藥品監督管理局根據保護公眾健康的要求，可以對批准生產的新藥設立監測期，對該新藥的安全性繼續進行監測。
監測期內的新藥，國家食品藥品監督管理局不批准其他企業生產和進口。
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Article 69 The monitoring period of a new drug shall be determined on the basis of the existing safety research materials and the research status at home and abroad. It shall not exceed five years commencing from the date of approval of manufacturing the drug.
| | 第六十九條 新藥的監測期根據現有的安全性研究資料和境內外研究狀況確定，自新藥批准生產之日起計算，最長不得超過5年。
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Article 70 For a new drug within the monitoring period, the drug manufacturer shall regularly inspect the manufacturing techniques, quality, stability, curative effect and adverse reactions, etc., and make a report each year to the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located.
Where any of the institutions relating to the manufacturing, operation, use, or inspection or supervision of drugs finds that a new drug has any serious quality problem, or causes any serious or unanticipated adverse reactions, it shall report, without delay, to the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government.
| | 第七十條 藥品生產企業應當經常考察處于監測期內的新藥的生產工藝、質量、穩定性、療效及不良反應等情況，並每年向所在地省、自治區、直轄市（食品）藥品監督管理部門報告。
有關藥品生產、經營、使用、檢驗或者監督的單位發現新藥存在嚴重質量問題、嚴重或者非預期的不良反應時，必須及時向省、自治區、直轄市（食品）藥品監督管理部門報告。
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Article 71 With respect to a new drug with any serious quality problem, or causing serious or unanticipated adverse reactions, the (food) drug regulatory departments of the provinces, autonomous regions or municipalities directly under the Central Government shall organize an investigation immediately and report it to the SFDA.
| | 第七十一條 省、自治區、直轄市（食品）藥品監督管理部門對存在嚴重質量問題、嚴重或者非預期的不良反應的新藥，應當立即組織調查，並報告國家食品藥品監督管理局。
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Article 72 If a drug manufacturer fails to perform its duties during the monitoring period of a new dryug, it shall be ordered to make corrections by the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government.
| | 第七十二條 藥品生產企業不按規定履行新藥監測期責任的，省、自治區、直轄市（食品）藥品監督管理部門應當責令其改正。
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Article 73 If a new drug, for which the monitoring period has been set, has not been manufactured within two years from the day of approval, the SFDA may approve the applications for manufacturing that new drug filed by other drug manufacturers and continue to monitor the new drug.
| | 第七十三條 藥品生產企業對設立監測期的新藥從獲准生產之日起2年內未組織生產的，國家食品藥品監督管理局可以批准其他藥品生產企業提出的生產該新藥的申請，並繼續對該新藥進行監測。
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Article 74 Where the SFDA has already approved any other applicant's clinical trials of drugs before a new drug enters into the monitoring period, such application may continue to be handled pursuant to the procedures for the application, examination and approval of drug registration. If the application conforms to relevant provisions, the SFDA may approve the manufacturing or import of the drug and monitor it together with such new drug manufactured by domestic drug manufacturers.
| | 第七十四條 新藥進入監測期之日起，國家食品藥品監督管理局已經批准其他申請人進行藥物臨床試驗的，可以按照藥品注冊申報與審批程序繼續辦理該申請；認為符合規定的，國家食品藥品監督管理局可以批准該新藥的生產或者進口，並對境內藥品生產企業生產的該新藥一並進行監測。
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Article 75 From the day when a new drug enters the monitoring period, no identical registration application filed by any other applicant may be accepted. If the SFDA has already accepted an application of any other applicant but not yet permitted this other applicant to conduct drug clinical trials, such application shall be returned to the applicant. After the monitoring period of such new drug ends, the applicant may file an application for the registration of a drug under existing national standards or for an impored drug.
| | 第七十五條 新藥進入監測期之日起，不再受理其他申請人的同品種注冊申請。已經受理但尚未批准進行藥物臨床試驗的其他申請人同品種申請，應當退回申請人；新藥監測期滿後，申請人可以提出已有國家標准藥品的申請或者進口藥品申請。
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Article 76 After an application for the registration of an imported drug is approved, if the domestic applicant has already been granted an approval to conduct clinical trials, the application may continue to be handled pursuant to the procedures for application, examination and approval of drug registration. The SFDA may approve the manufacturing of the drug if the requirements are met. The applicant may also withdraw that application and file a new application for registration of for which there have already been national standards. If the application for the clinical trial of the same drug filed by any other applicant has been accepted but not yet approved, such application shall be returned to the applicant, but the applicant may file a new application pursuant to the requirements for the registration of a drug under existing national standards.
| | 第七十六條 進口藥品注冊申請首先獲得批准後，已經批准境內申請人進行臨床試驗的，可以按照藥品注冊申報與審批程序繼續辦理其申請，認為符合規定的，國家食品藥品監督管理局可以批准其進行生產；申請人也可以撤回該項申請，重新提出已有國家標准藥品的注冊申請。對已經受理但尚未批准進行藥物臨床試驗的其他同品種申請，應當退回申請人；申請人可以提出已有國家標准藥品的注冊申請。
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Section 5. Transfer of New Drug Technologies
| | 第五節 新藥的技術轉讓
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Article 77 The “transfer of new drug technologies” refer to the act that the holder of a new drug certificate transfers the manufacturing technologies of the new drug to a drug manufacturer, and the latter files an application for the manufacturing of that new drug.
| | 第七十七條 新藥技術轉讓，是指新藥證書的持有者，將新藥生產技術轉讓給藥品生產企業，並由該藥品生產企業申請生產該新藥的行為。
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Article 78 The “transferor of new drug technologies” refers to the holder of a new drug certificate. If it has obtained the drug approval document number, it shall file an application for writing off the original drug approval document number when applying for transferring the new drug technologies.
| | 第七十八條 新藥技術的轉讓方應當是新藥證書的持有者。轉讓方已取得藥品批准文號的，申請新藥技術轉讓時，應當同時提出注銷其藥品批准文號的申請。
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Article 79 The new drug technologies shall be transferred to a drug manufacturer once and for all. If the said drug manufacturer cannot manufacture the drug for any special reasons, the holder of the new drug certificate may transfer the new drug technologies for a second time upon the strength of the contract by which the original transferee abandons the manufacturing of that new drug, or other relevant certification documents, etc. The SFDA shall write off the approval document number for the new drug of the original transferee pursuant to the provisions.
The enterprise accepting the transferred new drug technologies may not retransfer such technologies any more.
| | 第七十九條 新藥技術轉讓時，應當一次性轉讓給一個藥品生產企業。受讓的藥品生產企業由于特殊原因不能生產的，新藥證書持有者可以持該受讓方放棄生產該藥品的合同或者有關證明文件，將新藥技術再轉讓一次。原受讓方已就該新藥取得藥品批准文號的，國家食品藥品監督管理局應當按照規定注銷其藥品批准文號。
接受新藥技術轉讓的企業不得將該技術再次轉讓。
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Article 80 A drug manufacturer accepting the transferred new drug technologies shall have obtained a Manufacturing Permit for Medicinal Products and a certificate of the GMP. The new drug to be transferred shall fall within the scope of manufacturing as specified in the Manufacturing Permit for Medicinal Products and the certificate of the GMP of the transferee.
With regard to a newly established drug manufacturer, or a drug production enterprise that has newly built a drug manufacturing workshop or has newly added a type of drug preparation, after it obtains the Manufacturing Permit for Medicinal Products that specifies the corresponding manufacturing scope, it may file an application for transferring the new drug technologies. After it obtains the drug approval document number, it shall, within the time limit as specified in Article 6 of the Implementation Regulations of the Medicinal Product Administration Law, a certificate of the GMP that specifies the corresponding certification scope. Prior to the obtainment of such a certificate, the drug under the approved document number shall not be marketed.
| | 第八十條 接受新藥技術轉讓的藥品生產企業必須持有《藥品生產許可證》和《藥品生產質量管理規範》認證證書。新藥技術轉讓涉及的新藥應當與受讓方《藥品生產許可證》和《藥品生產質量管理規範》認證證書中載明的生產範圍和認證範圍一致。
新開辦藥品生產企業、藥品生產企業新建藥品生產車間或者新增生產劑型，在取得載明相應生產範圍的《藥品生產許可證》後，可以提出新藥技術轉讓的申請。在取得藥品批准文號後，必須在《藥品管理法實施條例》第六條規定的時限內取得載明相應認證範圍的《藥品生產質量管理規範》認證證書。取得認證證書前，已取得批准文號的藥品不得上市銷售。
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Article 81 When transferring the new drug manufacturing technologies, the holder of the new drug certificate shall sign a transfer contract with the transferee, and shall transfer all the technologies and materials to the transferee and guide the manufacturing of the latter, on a trial basis, for 3 successive batches of qualified products.
| | 第八十一條 新藥證書持有者轉讓新藥生產技術時，應當與受讓方簽定轉讓合同，將技術及資料全部轉讓給受讓方，並指導受讓方試制出質量合格的連續3個生產批號的樣品。
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Article 82 With respect to a new drug jointly developed by several institutions, the transfer of new drug technologies shall be proposed by the institutions that jointly signed the new drug certificate and a transfer contract shall be concluded.
| | 第八十二條 多個單位聯合研制的新藥進行新藥技術轉讓時，應當由新藥證書上聯合署名的單位共同提出，並簽定轉讓合同。
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Article 83 When transferring the new drug technologies, the holder of the new drug certificate and the transferee shall jointly file an application with the drug administration of the province, autonomous region or municipality directly under the Central Government where the transferee is located, fill in the Supplementary Drug Application Form, and submit the relevant materials with an attachment of the transfer contract.
| | 第八十三條 新藥證書持有者與受讓方應當共同向受讓方所在地省、自治區、直轄市（食品）藥品監督管理部門提出新藥技術轉讓申請，填寫《藥品補充申請表》，報送有關資料並附轉讓合同。
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Article 84 After accepting an application for the transfer of new drug technologies, the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall verify and check the spot of trial manufacturing, manufacturing equipment, manufacturing of samples and inspection records of the transferee, select samples and notify the testing institution of medicinal products to conduct an inspection.
| | 第八十四條 省、自治區、直轄市（食品）藥品監督管理部門受理新藥技術轉讓申請後，應當對受讓方的試制現場、生產設備、樣品生產與檢驗記錄進行核查，並進行抽樣，同時通知藥品檢驗所進行檢驗。
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Article 85 The testing institution of medicinal products undertaking the drug inspection shall finish the inspection within the prescribed time limit, work out an inspection report and submit it to the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government which notified it to make the inspection.
| | 第八十五條 接到注冊檢驗通知的藥品檢驗所，應當在規定的時限內完成檢驗，出具藥品注冊檢驗報告，報送通知其檢驗的省、自治區、直轄市（食品）藥品監督管理部門。
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Article 86 The (food) drug regulatory departments of the provinces, autonomous regions or municipalities directly under the Central Government shall examine the inspection report and relevant materials received by it and put forward examination opinions thereon, submit them to the SFDA and notify the applicant.
| | 第八十六條 省、自治區、直轄市（食品）藥品監督管理部門應當對收到的藥品注冊檢驗報告和有關資料進行審查並提出審查意見，報送國家食品藥品監督管理局，同時將審查意見通知申請人。
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Article 87 The SFDA shall make a comprehensive evaluation of the supplementary application for the transfer of new drug technologies. If it considers that it is necessary to conduct clinical trials, it shall issue to the applicant an Approval Document on Drug Clinical Trials.
The applicant shall, after finishing the clinical trials, submit the clinical trial materials to the SFDA.
| | 第八十七條 國家食品藥品監督管理局應當對新藥技術轉讓的補充申請進行全面審評，認為需要進行臨床試驗的，發給《藥物臨床試驗批件》。
申請人完成臨床試驗後，應當向國家食品藥品監督管理局報送臨床試驗資料。
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Article 88 If the SFDA considers that the supplementary application for the transfer of new drug technologies meets the relevant provisions, it shall issue an Approval Document on the Supplementary Drug Application and drug approval document number, and it shall simultaneously write off the drug approval document number that has already been obtained by the transferor. If it considers that the aforesaid supplementary application doesn't conform to the relevant provisions, it shall issue a Notice on Examination Opinions and explain the reasons therefore.
| | 第八十八條 國家食品藥品監督管理局對認為符合規定的新藥技術轉讓補充申請發給《藥品補充申請批件》和藥品批准文號，同時注銷轉讓方已取得的藥品批准文號；認為不符合規定的，發給《審批意見通知件》，並說明理由。
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Article 89 No application for the transfer of new drug technologies may be accepted after a new drug has entered its monitoring period. After the expiration of the monitoring period of the new drug, the applicant may file a registration application according to requirements for the drug under existing national standards.
| | 第八十九條 新藥進入監測期以後，不再受理該新藥技術轉讓的申請。新藥監測期滿後，申請人可以按照已有國家標准藥品的要求提出注冊申請。
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Chapter VI. Application and Examination & Approval of Drugs under Existing National Standards
| | 第六章 已有國家標准藥品的申報與審批
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Article 90 To apply for manufacturing a drug under existing national standards, the applicant shall be a drug manufacturer with a Manufacturing Permit for Medicinal Products and with a certificate of GMP. The drug for which the application is filed shall be in line with the manufacturing scope and certification scope as specified in the Manufacturing Permit for Medicinal Products and the certificate of GMP.
| | 第九十條 申請生產已有國家標准藥品的，應當是持有《藥品生產許可證》、《藥品生產質量管理規範》認證證書的藥品生產企業。申請人申請生產的藥品應當與《藥品生產許可證》和《藥品生產質量管理規範》認證證書中載明的生產範圍和認證範圍一致。
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Article 91 If a Manufacturing Permit for Medicinal Products, which specifies the corresponding manufacturing scope, has been obtained for a newly launched drug manufacturer, for a newly established drug manufacturing workshop of a drug manufacturer, or for the newly added form of preparation, a drug registration application may be filed.
| | 第九十一條 新開辦藥品生產企業、藥品生產企業新建藥品生產車間或者新增生產劑型，在取得載明相應生產範圍的《藥品生產許可證》後，可以提出藥品注冊申請。
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Article 92 After an applicant has finished the trial manufacturing pursuant to the relevant technical requirements, it shall fill out an Application Form for Drug Registration, and submit the relevant materials and drug samples to the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located.
| | 第九十二條 申請人按照有關技術要求完成試制工作後，應當填寫《藥品注冊申請表》，向所在地省、自治區、直轄市（食品）藥品監督管理部門報送有關資料和藥物實樣。
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Article 93 The (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall conduct a formal examination over the application materials. It shall accept them if they meet the relevant requirements, and it shall issue to the applicant a notice about the acceptance of drug registration application. If it considers that the application materials don't meet the relevant requirements, it shall reject them and issue to the applicant a notice about the rejection of the drug registration application and shall make an explanation.
The (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall, within five working days from the day when it accepts an application, organize an on-spot inspection over the manufacturing process and conditions, select samples from the products of three successive batch numbers and give the designated testing institution of medicinal products a sample inspection notice. It shall examine the application materials within the prescribed time limit, put forward its examination opinions, submit the examination opinions and application materials to the SFDA, and notify the applicant simultaneously.
| | 第九十三條 省、自治區、直轄市（食品）藥品監督管理部門對申報資料進行形式審查，認為符合要求的，予以受理，出具藥品注冊申請受理通知書；認為不符合要求的，不予受理，出具藥品注冊申請不予受理通知書，並說明理由。
省、自治區、直轄市（食品）藥品監督管理部門應當自申請受理之日起5日內組織對生產情況和條件進行現場核查；抽取連續3個生產批號的樣品，並向藥品檢驗所發出注冊檢驗通知。省、自治區、直轄市（食品）藥品監督管理部門應當在規定的時限內對申報資料進行審查，提出審查意見，並將審查意見、核查報告及申報資料報送國家食品藥品監督管理局，同時通知申請人。
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Article 94 A testing institution of medicinal products receiving the notice on registration inspection shall conduct an inspection on the selected samples, and send a drug registration inspection report to the SFDA within the prescribed time limit, and simultaneously send a copy to the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government, which gave it an inspection notice, and to the applicant as well.
| | 第九十四條 接到注冊檢驗通知的藥品檢驗所對抽取的樣品進行檢驗，並在規定的時限內將藥品注冊檢驗報告報國家食品藥品監督管理局，同時抄送通知其檢驗的省、自治區、直轄市（食品）藥品監督管理部門和申請人。
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Article 95 The SFDA shall review examination opinions and application materials. Where necessary, it may demand the applicant to make supplements. If it believes that clinical trials should be conducted, it shall issue to the applicant an Approval Document on Drug Clinical Trials.
After finishing the clinical trials, the applicant shall submit clinical trial materials to the SFDA.
| | 第九十五條 國家食品藥品監督管理局應當對審查意見和申報資料進行審核，必要時可以要求申請人補充資料。認為需要進行臨床試驗的，發給《藥物臨床試驗批件》。
申請人完成臨床試驗後，應當向國家食品藥品監督管理局報送臨床試驗資料。
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Article 96 If the SFDA considers that an application conforms to relevant provisions, it shall issue to the applicant an Approval of Drug Registration as well as the drug approval document number. If it considers that the application doesn't meet relevant requirements, it shall issue to the applicant a Notice on Examination Opinions and explain the reason for rejection.
As for a newly initiated drug manufacturers or a drug manufacturer that has newly established drug manufacturing workshops or has newly added any form of drug preparation, if it fails to obtain a certificate of GMP specifying the corresponding certification scope, such drug manufactured by it shall not be marketed.
| | 第九十六條 國家食品藥品監督管理局對認為符合規定的申請發給《藥品注冊批件》和藥品批准文號；認為不符合規定的，發給《審批意見通知件》，並說明理由。
新開辦藥品生產企業、藥品生產企業新建藥品生產車間或者新增生產劑型，未取得載明相應認證範圍的《藥品生產質量管理規範》認證證書的，其生產的藥品不得上市銷售。
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Article 97 The SFDA and the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government do not accept any application filed on the basis of tentative standards for the registration of for which there have already been national standards.
| | 第九十七條 省、自治區、直轄市（食品）藥品監督管理部門不受理依據試行標准提出的已有國家標准的藥品注冊申請。
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Article 98 With regard to an application for the registration of a drug for which there have been already national standards that need further evaluation of the curative effect and safety, the SFDA may decide to suspend the acceptance or examination & approval of the application.
| | 第九十八條 對需要進一步評價藥品療效和安全性的已有國家標准藥品的注冊申請，國家食品藥品監督管理局可以作出暫停受理或者審批的決定。
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Article 99 If three batches of drugs manufactured for the application for the drug approval document number were manufactured in workshops with a Manufacturing Permit for Medicinal Products and a certificate of GMP, those drugs may be marketed within their effective periods after passing the inspection conducted by the testing institution of medicinal products as prescribed in Articles 147 and 148 of these Measures and obtaining the drug approval document number.
| | 第九十九條 為申請藥品批准文號所生產的連續3個生產批號的樣品，在持有《藥品生產許可證》和《藥品生產質量管理規範》認證證書的車間生產的，經依據本辦法第一百四十七條和第一百四十八條確定的藥品檢驗所檢驗合格並取得藥品批准文號後，可以在藥品的有效期內上市銷售。
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Chapter VII. Application and Examination & Approval of Imported Drugs
| | 第七章 進口藥品的申報與審批
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Section 1. Registration of Imported Drugs
| | 第一節 進口藥品的注冊
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Article 100 As to an application for the import of a drug, a permit for marketing as issued by the country or region where the overseas drug manufacturer is located must have been obtained; if no permit for marketing has been obtained, but the SFDA confirms that the said drug is safe, effective and needed for clinical use, the import thereof may be approved.
The drug applied for import shall meet the good manufacturing practice of the country or region where it is manufactured and the requirements of the GMP of China.
| | 第一百條 申請進口的藥品，必須獲得境外制藥廠商所在生產國家或者地區的上市許可；未在生產國家或者地區獲得上市許可，但經國家食品藥品監督管理局確認該藥品安全、有效而且臨床需要的，可以批准進口。
申請進口的藥品應當符合所在國家或者地區藥品生產質量管理規範及中國《藥品生產質量管理規範》的要求。
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Article 101 To apply for the registration of imported drugs, an applicant shall file an application to the SFDA by filling out an Application Form for Drug Registration, and submit it alongside relevant materials and samples, as well as supporting documents.
| | 第一百零一條 申請進口藥品注冊的，應當填寫《藥品注冊申請表》，報送有關資料和樣品，提供相關證明文件，向國家食品藥品監督管理局提出申請。
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Article 102 The SFDA shall conduct a formal examination over the application materials, accept the application if the requirements are met, issue to the applicant an acceptance notice and give the National Institutes for Food and Drug Control (“NIFDC”) a notice of drug registration inspection. If it considers that the application doesn't meet the relevant requirements, it shall reject it and give the applicant a notice on rejection of a drug registration application and explain the reasons therefore.
The SFDA shall, where it so requires, make on-spot investigations over the drug development process and manufacturing conditions.
| | 第一百零二條 國家食品藥品監督管理局對申報資料進行形式審查，認為符合要求的，予以受理，出具藥品注冊申請受理通知書，並通知中國藥品生物制品檢定所組織對3個生產批號的樣品進行注冊檢驗；認為不符合要求的，不予受理，出具藥品注冊申請不予受理通知書，並說明理由。
國家食品藥品監督管理局根據需要，可以組織對研制情況及生產條件進行現場核查，並抽取樣品。
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Article 103 After finishing the registration inspection of the imported drug, the NIFDC shall submit the verified drug standards, inspection report, and verification opinions to the SFDA.
| | 第一百零三條 中國藥品生物制品檢定所完成進口藥品注冊檢驗後，應當將複核的藥品標准、藥品注冊檢驗報告和複核意見報送國家食品藥品監督管理局。
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Article 104 The SFDA shall organize a comprehensive evaluation of the application materials. It may demand the applicant to make supplements where necessary. If it believes that it is necessary to conduct clinical trials, it shall issue to the applicant an Approval Document on the Drug Clinical Trials. If it considers that the application doesn't meet the relevant requirements, it shall issue to the applicant a Notice on Examination Opinions and explain the reasons therefore.
| | 第一百零四條 國家食品藥品監督管理局對申報資料進行全面審評，必要時可以要求申請人補充資料。認為需要進行臨床試驗的，發給《藥物臨床試驗批件》；認為不符合規定的，發給《審批意見通知件》，並說明理由。
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Article 105 After the clinical trial has been approved, the applicant shall carry it out pursuant to Chapter IV of these Measures and the relevant requirements.
After the clinical trial is ended, the applicant shall fill out an Application Form for Drug Registration, submit the clinical trial materials, samples and other modified and supplemented materials pursuant to the provisions, offer the basis and reasons in details and supply the relevant certification documents.
| | 第一百零五條 臨床試驗獲得批准後，申請人應當按照本辦法第四章及有關要求進行試驗。
臨床試驗結束後，申請人應當填寫《藥品注冊申請表》，按照規定報送臨床試驗資料、樣品及其他變更和補充的資料，並詳細說明依據和理由，提供相關證明文件。
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Article 106 The SFDA shall make a comprehensive evaluation of the clinical trial materials submitted by an applicant and it may demand the applicant to make supplements where necessary. If it considers the applicant meets the relevant requirements, it may issue to it an Import Drug License. Where a pharmaceutical manufacturer from Hong Kong, Macao or Taiwan applies for the registration of a drug, the procedures for applying for the registration of imported drugs shall apply; if it meets the relevant requirements, the SFDA shall issue to it a Pharmaceutical Product License; it if doesn't satisfy the relevant requirements, the SFDA shall issue to it a Notice on Examination Opinions and explain the reasons therefore.
| | 第一百零六條 國家食品藥品監督管理局組織對報送的臨床試驗等資料進行全面審評，必要時可以要求申請人補充資料。認為符合規定的，發給《進口藥品注冊證》；中國香港、澳門和台灣地區的制藥廠商申請注冊的藥品，參照進口藥品注冊申請的程序辦理，認為符合要求的，發給《醫藥產品注冊證》。認為不符合要求的，發給《審批意見通知件》，並說明理由。
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Article 107 As to an application for importing drug preparations, the applicant shall provide certifications of the legal sources of the packaging materials and containers have direct contact with the drugs, and certifications documents about the legal sources of the APIs and supplementary materials used for manufacturing those preparations. If the APIs and supplementary materials haven't been approved by the SFDA, the applicant shall submit the study materials relating to the manufacturing techniques, quality indications and inspection methods.
| | 第一百零七條 申請進口藥品制劑，必須提供直接接觸藥品的包裝材料和容器合法來源的證明文件、用于生產該制劑的原料藥和輔料合法來源的證明文件。原料藥和輔料尚未取得國家食品藥品監督管理局的批准的，應當報送有關生產工藝、質量指標和檢驗方法等的研究資料。
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Article 108 When approving the import of a drug, the SFDA shall simultaneously announce the ratified registration standards and specifications of the imported drug.
| | 第一百零八條 國家食品藥品監督管理局在批准進口藥品的同時，發布經核准的進口藥品注冊標准和說明書。
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Section 2. Registration of Sub-packaging of Imported Drugs
| | 第二節 進口藥品分包裝的注冊
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Article 109 The Subpackaging of imported drugs shall refer to changing big drug packages into smaller ones after the final preparations are finished overseas, or making external packaging, placing specifications and affixing labels, etc. to the drugs of which the internal packaging has been finished.
| | 第一百零九條 進口藥品分包裝，是指藥品已在境外完成最終制劑生產過程，在境內由大包裝規格改為小包裝規格，或者對已完成內包裝的藥品進行外包裝、放置說明書、粘貼標簽等。
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Article 110 The following conditions shall be satisfied when an application is filed for subpackaging an imported drug:
| | 第一百一十條 申請進口藥品分包裝，應當符合下列要求：
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(1) The applicant has already obtained an Import Drug License or Pharmaceutical Product License for the drug it applies for sub-packaging;
| | （一）申請進行分包裝的藥品已經取得了《進口藥品注冊證》或者《醫藥產品注冊證》；
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(2) The drug shall fall within a category that has not yet been manufactured within China, or within a category of which the manufacturing within China can't meet the clinical needs;
| | （二）該藥品應當是中國境內尚未生產的品種，或者雖有生產但是不能滿足臨床需要的品種；
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(3)The same category of drug manufactured by the same drug manufacturer shall be sub-packaged by one drug manufacturer, and the sub-packaging period shall not exceed the effective period as specified in the Import Drug License or Pharmaceutical Product License;
| | （三）同一制藥廠商的同一品種應當由一個藥品生產企業分包裝，分包裝的期限不得超過《進口藥品注冊證》或者《醫藥產品注冊證》的有效期；
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(4)Except for tablets and capsules, the sub-packaging of other types of preparations shall be completed abroad;
| | （四）除片劑、膠囊外，分包裝的其他劑型應當已在境外完成內包裝；
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(5)The drug manufacturer that accepts the sub-packaging work shall hold a Manufacturing Permit for Medicinal Products. As to an application for sub-packaging any imported bare tablets or capsules within China, the drug manufacturer that accepts the sub-packaging work shall not only hold Manufacturing Permit for Medicinal Products, but also a certificate of the GMP in line with the form of drug to be sub-packaged; and
| | （五）接受分包裝的藥品生產企業，應當持有《藥品生產許可證》。進口裸片、膠囊申請在國內分包裝的，接受分包裝的藥品生產企業還應當持有與分包裝的劑型相一致的《藥品生產質量管理規範》認證證書；
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(6)An application for sub-packaging an imported drug shall be filed no later than one year prior to the expiration of the valid period of the Import Drug License or Pharmaceutical Product License.
| | （六）申請進口藥品分包裝，應當在該藥品《進口藥品注冊證》或者《醫藥產品注冊證》的有效期屆滿前1年以前提出。
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Article 111 An overseas drug manufacturer shall sign a contract on sub-packaging of imported drugs with the domestic drug manufacturer, and fill in a Supplementary Drug Application Form.
| | 第一百一十一條 境外制藥廠商應當與境內藥品生產企業簽訂進口藥品分包裝合同，並填寫《藥品補充申請表》。
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Article 112 To apply for the subpackaging of a imported drug, the applicant shall file with the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the drug manufacturer that accepts the sub-packaging work is located, submit a Supplementary Drug Application Form filled out by the entrusting party, as well as other relevant materials and samples. After the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government has conducted a formal examination over the application materials, and if it considers that the application meets the relevant conditions, it shall accept it and issue to the applicant a notice about the acceptance of the drug registration application. If it considers that the application doesn't meet the relevant requirements, it shall reject it and shall give the applicant a rejection notice with the reasons of rejection.
After the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government puts forward its examination opinions, it shall submit the application materials and the examination opinions to the SFDA and shall simultaneously inform the applicant.
| | 第一百一十二條 申請進口藥品分包裝的，應當由接受分包裝的藥品生產企業向所在地省、自治區、直轄市（食品）藥品監督管理部門提出申請，提交由委托方填寫的《藥品補充申請表》，報送有關資料和樣品。省、自治區、直轄市（食品）藥品監督管理部門對申報資料進行形式審查後，認為符合要求的，予以受理，出具藥品注冊申請受理通知書；認為不符合要求的，不予受理，出具藥品注冊申請不予受理通知書，並說明理由。
省、自治區、直轄市（食品）藥品監督管理部門提出審核意見後，將申報資料和審核意見報送國家食品藥品監督管理局審批，同時通知申請人。
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Article 113 The SFDA shall examine the application materials. If it considers that the application meets the relevant provisions, it shall approve it and issue to the applicant an Approval Document about the Supplementary Drug Application and a drug approval document number. If it considers that the application doesn't satisfy the relevant conditions, it shall give the applicant a Notice on Examination Opinions with the reasons of rejection.
| | 第一百一十三條 國家食品藥品監督管理局對報送的資料進行審查，認為符合規定的，予以批准，發給《藥品補充申請批件》和藥品批准文號。認為不符合規定的，發給《審批意見通知件》，並說明理由。
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Article 114 A sub-packaged imported drug shall comply with the registration standards for the imported drug.
| | 第一百一十四條 進口分包裝的藥品應當執行進口藥品注冊標准。
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Article 115 The specifications and packing labels of a sub-packaged imported drug shall be identical with those of the imported drug, and shall simultaneously be given a clear indication of the registered number of the approval of the sub-packaged drug as well as the name of the sub-packaging drug manufacturer.
| | 第一百一十五條 進口分包裝藥品的說明書和包裝標簽必須與進口藥品的說明書和包裝標簽一致，並且應當同時標注分包裝藥品的批准文號和分包裝藥品生產企業的名稱。
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Article 116 The import inspection of overseas preparations in large packages shall follow the relevant provisions of the SFDA. The same drug standards shall be observed in the inspection of sub-packaged products and the import inspection.
| | 第一百一十六條 境外大包裝制劑的進口檢驗按照國家食品藥品監督管理局的有關規定執行。包裝後產品的檢驗與進口檢驗執行同一藥品標准。
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Article 117 The overseas pharmaceutical manufacturer that supplies a drug shall be responsible for the quality of the sub-packaged drug. If the sub-packaged drug has any quality problem, the SFDA may revoke the registered number of the approval of the sub-packaged drug. Where necessary, it may, in accordance with Article 42 of the Medicinal Product Administration Law, revoke the Import Drug License or Pharmaceutical Product License pertaining to the drug.
| | 第一百一十七條 提供藥品的境外制藥廠商應對分包裝後藥品的質量負責。分包裝後的藥品出現質量問題的，國家食品藥品監督管理局可以撤銷分包裝藥品的批准文號，必要時可以依照《藥品管理法》第四十二條的規定，撤銷該藥品的《進口藥品注冊證》或者《醫藥產品注冊證》。
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Chapter VIII. Application and Examination & Approval of Nonprescription Drugs
| | 第八章 非處方藥的注冊
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Article 118 The term “nonprescription drugs” refers to the drugs promulgated by the SFDA that the customers may judge, purchase and use by themselves without the prescriptions given by practicing physicians and practicing assistant physicians.
| | 第一百一十八條 非處方藥，是指由國家食品藥品監督管理局公布的，不需要憑執業醫師和執業助理醫師處方，消費者可以自行判斷、購買和使用的藥品。
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Article 119 If a drug applied for registration is under any of the following circumstances, the applicant may simultaneously file an application for managing it as a nonprescription drug:
| | 第一百一十九條 申請注冊的藥品屬于以下情形的，可以同時提出按照非處方藥管理的申請：
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(1) It has already been manufactured or imported as nonprescription drug under the existing state drug standard;
| | （一）已有國家藥品標准的非處方藥的生產或者進口；
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(2) It is a drug of a changed form of a nonprescription drug as determined by the SFDA, but with the same applicable diseases, dosage of administration and drug delivery route;
| | （二）經國家食品藥品監督管理局確定的非處方藥改變劑型，但不改變適應症或者功能主治、給藥劑量以及給藥途徑的藥品；
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(3) It is a new compound preparation composed of the active ingredients of nonprescription drug determined by the SFDA.
| | （三）使用國家食品藥品監督管理局確定的非處方藥活性成份組成的新的複方制劑。
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Article 120 For a drug that meets the requirements in Article 119 (1) of the present Provisions, the applicant shall, in the column “Supplementary Matters of Application” of the Application Form for Drug Registration, indicate the item of nonprescription drug, the SFDA shall determine the drug as a nonprescription drug when approving the manufacturing or import of that drug. If the applicant fails to indicate the item of nonprescription drug in the Drug Registration Application, it shall, after the SFDA approves the drug registration, go through the register formalities in accordance with the relevant provisions on the management of classification between prescription drugs and nonprescription drugs, as well as the examination, approval and register of nonprescription drugs.
| | 第一百二十條 對符合本辦法第一百一十九條（一）情形的藥品，申請人應當在《藥品注冊申請表》的“附加申請事項”中標注非處方藥項，國家食品藥品監督管理局批准藥品注冊的同時，將該藥品確定為非處方藥；未在《藥品注冊申請表》中標注非處方藥項的，申請人應當在國家食品藥品監督管理局批准藥品注冊後，按照處方藥與非處方藥分類管理及非處方藥審核登記的有關規定進行登記。
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Article 121 For a drug that meets the relevant conditions as prescribed in Article 119 (2) or (3), the applicant may mark it as a nonprescription drug in the column “Supplementary Matters of Application” of the Application Form for Drug Registration, and if the SFDA believes that it meets the relevant provisions regarding nonprescription drugs, it may, when granting approval for drug registration, determine it as a nonprescription drug. If it believes that it does not meet the relevant provisions regarding nonprescription drugs, it shall regard it as a prescription drug in its examination, approval and management process.
| | 第一百二十一條 對符合本辦法第一百一十九條（二）或者（三）情形的藥品，申請人可以在《藥品注冊申請表》的“附加申請事項”中標注非處方藥項，國家食品藥品監督管理局認為符合非處方藥有關規定的，可以在批准藥品注冊時，將該藥品確定為非處方藥；認為不符合非處方藥有關規定的，按照處方藥審批和管理。
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Article 122 As for a drug that meets the relevant conditions as prescribed in Article 119 of the present Provisions, if the applicant fails to indicate the item of nonprescription drug in the column “Supplementary Matters of Application” of the Application Form for Drug Registration, the SFDA shall regard it as a prescription drug in the examination, approval and management process.
| | 第一百二十二條 對符合本辦法第一百一十九條規定情形的藥品，申請人未在《藥品注冊申請表》的“附加申請事項”中標注非處方藥項的，國家食品藥品監督管理局按照處方藥進行審批和管理。
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Article 123 Generally speaking, no clinical trial is required for a chemical medicine as mentioned in Article 119 (1) or (2) of the present Provisions, however, bioequivalence studys shall be conducted for a solid preparation for oral use. As for a finished Chinese traditional medicine, clinical trials shall be conducted for it pursuant to the relevant requirements of the present Provisions.
| | 第一百二十三條 屬于本辦法第一百一十九條（一）或者（二）情形的化學藥品，一般不需要進行臨床試驗，但口服固體制劑應當進行生物等效性試驗。中成藥應當按照本辦法的有關要求進行臨床試驗。
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Article 124 As for a drug as mentioned in Article 119 (3), the prescription basis shall be specified, and clinical trials shall be conducted for it where necessary.
| | 第一百二十四條 屬于本辦法第一百一十九條（三）情形的藥品，應當說明其處方依據，必要時應當進行臨床試驗。
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Article 125 A non-prescription drug registration application, the specifications and packaging labels shall satisfy the relevant provisions on nonprescription drugs. The other application materials shall conform to the relevant provisions on prescription drugs.
| | 第一百二十五條 非處方藥的注冊申請，藥品說明書和包裝標簽應當符合非處方藥的有關規定，其他申報資料應當符合處方藥的有關規定。
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Article 126 The procedures for the application, examination and approval of imported drug shall be applicable to an application filed for the registration of an imported drug as a nonprescription drug. The technical requirements for the said drug shall be in line with those for the domestically manufactured nonprescription drug.
| | 第一百二十六條 作為非處方藥的進口藥品申請，適用進口藥品的申報和審批程序，其技術要求與境內生產的非處方藥的技術要求一致。
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Article 127 As to an application for the re-registration of an imported drug as a nonprescription drug, the SFDA shall complete the examination and approval formalities in accordance with the relevant provisions on the re-registration of imported drug as well as the management of nonprescription drugs. When applying for the re-registration of an imported drug as a nonprescription drug, the applicant isn't required to go through the examination, approval and registration formalities for nonprescription drugs in the food and drug administration at the province level.
| | 第一百二十七條 作為非處方藥的進口藥品申請再注冊時，國家食品藥品監督管理局按照進口藥品再注冊和非處方藥管理的有關規定予以審批。進口藥品作為非處方藥申請再注冊的，申請人無需向省級食品藥品監督管理局進行非處方藥品審核登記。
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Article 128 As to a nonprescription drug upon approval of the SFDA, if it is found that it is improper to continue to manage it a nonprescription drug in the course of its use, the SFDA may modify it into a prescription drug.
| | 第一百二十八條 經國家食品藥品監督管理局批准的非處方藥，在使用中發現不適合繼續作為非處方藥管理的，國家食品藥品監督管理局可以將其轉換為處方藥。
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Chapter IX. Supplementary Drug Application and Examination & Approval Thereof
| | 第九章 藥品的補充申請與審批
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Article 129 An applicant shall file a supplementary application when it modifies the drug approval certification document, its attached drug standards, dispensatory, any matter indicated in the labels, or the manufacturing techniques that may affect the drug quality.
| | 第一百二十九條 變更藥品批准證明文件及其所附藥品標准、藥品說明書和標簽所載事項的，以及改變可能影響藥品質量的生產工藝等事項，應當提出藥品補充申請。
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Article 130 The applicant shall fill in a Supplementary Drug Application Form, and submit the relevant materials and explanations to the (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located. The (food) drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall conduct a formal examination over the application materials. If it considers that the said application materials meet the relevant requirements, it shall accept them and shall give the applicant a notification about the acceptance of drug registration application. If it considers that the said don't meet the relevant requirements, it shall reject them and give the applicant a notification about the rejection of drug registration application and explain the reasons therefore.
| | 第一百三十條 申請人應當填寫《藥品補充申請表》，向所在地省、自治區、直轄市（食品）藥品監督管理部門報送有關資料和說明。省、自治區、直轄市（食品）藥品監督管理部門對申報資料進行形式審查，認為符合要求的，予以受理，出具藥品注冊申請受理通知書；認為不符合要求的，不予受理，出具藥品注冊申請不予受理通知書，並說明理由。
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Article 131 For a supplementary application relating to an imported drug, the applicant shall submit the relevant materials and explanations to the SFDA, and present the modification approval document issued by the drug authorities of the country or region where the drug is manufactured. The SFDA shall conduct a formal examination over the application materials. If it considers that the said application materials meet the relevant requirements, it shall accept them and shall give the applicant a notification about the acceptance of drug registration application. If it considers that the said application doesn't meet the relevant requirements, it shall reject the application and give the applicant a notification about the rejection of drug registration application and shall explain the reasons therefore.
| | 第一百三十一條 提出進口藥品的補充申請時，申請人應當向國家食品藥品監督管理局報送有關資料和說明，提交生產國家或者地區藥品管理機構批准變更的文件。國家食品藥品監督管理局對申報資料進行形式審查，認為符合要求的，予以受理，出具藥品注冊申請受理通知書；認為不符合要求的，不予受理，出具藥品注冊申請不予受理通知書，並說明理由。
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Article 132 As to a supplementary application for changing the enterprise name, drug packaging labels under the pertinent provisions, or the dispensatory pursuant to the requirements of the SFDA, the (food) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall, if it considers it meets the relevant requirement, accept and approve it upon examination, issue the applicant an Approval Document about the Supplementary Drug Application and submit the application to the SFDA for record. If it considers that the application doesn't meet the relevant requirements, it shall give the applicant a Notice on Examination Opinions and explain the reasons therefore.
| | 第一百三十二條 改變企業名稱、按規定變更藥品包裝標簽、根據國家食品藥品監督管理局的要求修改說明書等的補充申請，由省、自治區、直轄市（食品）藥品監督管理部門受理並審批，認為符合規定的，發給《藥品補充申請批件》，並報送國家食品藥品監督管理局備案；認為不符合規定的，發給《審批意見通知件》，並說明理由。
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Article 133 As to a supplementary application for modifying drug standards, altering supplementary materials, adding applicable diseases or functions of a drug, etc, after the (food) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall, after making examination and putting forward its examination opinions, submit it to the SFDA for examination and approval, and simultaneously notify the applicant.
| | 第一百三十三條 修改藥品注冊標准、變更輔料、中藥增加功能主治等的補充申請，由省、自治區、直轄市（食品）藥品監督管理部門受理並提出審核意見後，報送國家食品藥品監督管理局審批，同時通知申請人。
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Article 134 A supplementary application concerning an imported drug shall be subject to the examination and approval of the SFDA. A supplementary application for modifying the specifications, supplementing and perfecting the safety content in the specifications, changing the packaging label or appearance of the drug, or modifying the registration agency in accordance with the state drug standards, or requirements of the SFDA, shall be subject to recording by the SFDA. If the SFDA raises no objection within 20 days after the acceptance, the applicant may execute that supplementary application.
| | 第一百三十四條 進口藥品的補充申請，由國家食品藥品監督管理局審批。其中根據國家藥品標准或者國家食品藥品監督管理局的要求修改說明書、補充完善說明書的安全性內容、按規定變更藥品包裝標簽或者藥品外觀、改變注冊代理機構的補充申請，由國家食品藥品監督管理局備案。國家食品藥品監督管理局受理後20日內沒有提出異議的，申請人可以執行相應的補充申請事項。
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Article 135 As to a supplementary application for the change of the drug manufacturing place or for a drug approval document number upon the strength of a new drug certificate, the (food) drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall check the trial manufacturing place, select samples for inspection use, and notify the designated testing institution of medicinal products to make an inspection over the samples.
As to a supplementary application for modifying the drug standards, the testing institution of medicinal products shall review the standard if necessary.
| | 第一百三十五條 對改變藥品生產場地、持有新藥證書申請藥品批准文號等的補充申請，省、自治區、直轄市（食品）藥品監督管理部門應當組織對試制現場進行核查，抽取檢驗用樣品，並通知藥品檢驗所進行樣品檢驗。
修改藥品注冊標准的補充申請，藥品檢驗所在必要時應當進行標准複核。
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Article 136 When examining a Supplementary Drug Application, the SFDA may demand the applicant to submit supplementary materials. If it considers that the Supplementary Drug Application meets the relevant requirements, it shall grant to the applicant an Approval Document on Supplementary Drug Application. If it considers that the application doesn't meet the relevant requirements, it shall give the applicant a Notification about its Examination Opinionsexplain the reasons therefore.
．．．．．． | | 第一百三十六條 國家食品藥品監督管理局對藥品補充申請進行的審查，必要時可以要求申請人補充資料。認為符合規定的，發給《藥品補充申請批件》；認為不符合規定的，發給《審批意見通知件》，並說明理由。
需要換發藥品批准證明文件的，原藥品批准證明文件由國家食品藥品監督管理局予以注銷；需要增發藥品批准證明文件的，原藥品批准證明文件繼續有效。
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