新药Ⅰ期临床试验申请申报资料
FDA-NDA新药Ⅰ期临床试验申报资料(英语原文)
Guidance for IndustryContent and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, IncludingWell-Characterized, Therapeutic, Biotechnology-derived ProductsCenter for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)November 1995CLIN 2TABLE OF CONTENTSI.INTRODUCTION (1)II.CURRENT REQUIREMENTS AND PRACTICES (2)III.CLARIFICATIONS OF PRESENT IND REGULATIONS (2)A.Cover Sheet (3)B.Table of Contents (3)C.Introductory Statement and General Investigational Plan (3)D.Investigator's Brochure (3)E.Protocols (3)F.Chemistry, Manufacturing, and Control Information (4)G.Pharmacology and Toxicology Information (10)H.Previous Human Experience with the Investigational Drug (14)I.21 CFR 312.23(a)(10), (11) and (b), (c), (d), and (e) (14)IV.REFERENCES (14)iThis guidance has been prepared by the Center for Drug Evaluation and 1Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. Although this guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the industry, it does represent the agency’s current thinking on data requirement issues related to the initial entry of an unapproved drug into human studies in the United States. Foradditional copies of this guidance, contact the Consumer Affairs Branch (formerly the Executive Secretariat Staff), HFD-210, CDER, FDA, 5600 Fishers Lane, Rockville, MD 20857 (Phone: 301-594-1012) or the Congressional and Consumer Affairs Branch (HFM-12), CBER, FDA, 1401 Rockville Pike (STE 200N), Rockville, MD 20852-1448(Phone: 301-594-1800 or 800-835-4709). An electronic version of this guidance is also available via Internet by connecting to the CDER file transfer protocol (FTP)server ().As used throughout this guidance, the term "drugs" includes well-characterized,2therapeutic, biotechnology-derived products.GUIDANCE FOR INDUSTRY 1CONTENT AND FORMATOF INVESTIGATIONAL NEW DRUG APPLICATIONS (INDs) FOR PHASE 1 STUDIES OF DRUGS, INCLUDING WELL-CHARACTERIZED, THERAPEUTIC, BIOTECHNOLOGY-DERIVEDPRODUCTSI.INTRODUCTIONWith FDA's recent successes in meeting the Prescription Drug User Fee Act of 1992 (PDUFA) review action performance goals, and the resulting significant declines in mean and median time from submission of a marketing application to approval for marketing, attention has turned to increasing the efficiency of other components of the drug development process without sacrificing the long-standing safety and efficacy standards Americans expect their drug products to meet. One part of IND regulation of particular interest - under active discussion for more than two years and the subject of various degrees of attention since the McMahon Committee - is the regulation of the initial testing of drugs in humans (i.e., Phase 1 trials).This guidance clarifies requirements for data and data presentation in 21 CFR 312.22 and 312.23 related to the initial entry into human studies in the United States of an investigational drug, including well-characterized, therapeutic,biotechnology-derived products . Present regulations allow a great deal of 2flexibility in the amount and depth of various data to be submitted in an INDdepending in large part on the phase of investigation and the specific humantesting being proposed. In some cases, the extent of that flexibility has not been appreciated. FDA believes clarifications of many of these requirements will help expedite entry of new drugs into clinical testing by increasing transparency and reducing ambiguity and inconsistencies, and by reducing the amount ofinformation submitted, while providing FDA with the data it needs to assess the safety of the proposed Phase 1 study. If the guidance specified in thisdocument is followed, IND submissions for Phase 1 studies should usually notbe larger than two to three, three inch, 3-ring binders ("jackets").The most significant clarifications are: 1) the explicit willingness to accept anintegrated summary report of toxicology findings based upon the unaudited draft toxicologic reports of completed animal studies as initial support for humanstudies, and 2) specific manufacturing data appropriate for a Phase 1investigation. For products not covered by this Guidance, other FDA guidance documents should be consulted. In addition, the Center responsible for theproduct may be contacted for guidance.Because of the manufacturing and toxicologic differences between well-characterized, therapeutic, biotechnology-derived products and other biologicproducts, this Guidance only applies to drugs and well-characterized,therapeutic, biotechnology-derived products. For products not covered by thisGuidance, the Center responsible for the product should be contacted forguidance.This guidance applies equally to both commercial and individual investigatorsponsored INDs.II.CURRENT REQUIREMENTS AND PRACTICESUnder current regulations, any use in the United States of a drug product notpreviously authorized for marketing in the United States first requiressubmission of an IND to the FDA. Current regulations at 21 CFR 312.22 and312.23 contain the general principles underlying the IND submission and thegeneral requirements for an IND's content and format.III.CLARIFICATIONS OF PRESENT IND REGULATIONSAn IND submission for Phase 1 studies is required by regulation to contain thesections enumerated below. Clarifications are described when appropriatebeneath each section heading.2A.Cover Sheet (FDA Form-1571) [21 CFR 312.23(a)(1)]:No clarifications.B.Table of Contents [21 CFR 312.23(a)(2)]:No clarifications.C.Introductory Statement and General Investigational Plan [21 CFR312.23(a)(3)]:Regulations repeatedly describe this section as brief. Ordinarily, two tothree pages should suffice. The information requested here is intendedto place the developmental plan for the drug into perspective and to help FDA anticipate sponsor needs. Often a sponsor in the first humanstudies is simply attempting to determine early pharmacokinetic andperhaps early pharmacodynamic properties of the drug. Detaileddevelopmental plans are contingent on the outcomes of such studies. In that case, sponsors should simply state this in this section and notattempt to develop and write detailed developmental plans that will, in all likelihood, change considerably should the product proceed to furtherdevelopment.D.Investigator's Brochure [21 CFR 312.23(a)(5)]:Under the auspices of the International Conference on Harmonization(ICH), a document that provides general guidance on the Investigator'sBrochure has been developed and will soon be published in the FederalRegister (Good Clinical Practice: Guideline for the Investigator'sBrochure). Sponsors are referred to this document for further information on recommended elements of an Investigator's Brochure.E.Protocols [21 CFR 312.23(a)(6)]:The regulation requires submission of a copy of the protocol for theconduct of each proposed clinical trial. Sponsors are reminded that theregulations were changed in 1987 specifically to allow Phase 1 studyprotocols to be less detailed and more flexible than protocols for Phase 2 or 3 studies. This change recognized that these protocols are part of an early learning process and should be adaptable as information isobtained, and that the principal concern at this stage of development isthat the study be conducted safely. The regulations state that Phase 1protocols should be directed primarily at providing an outline of the3investigation: an estimate of the number of subjects to be included; adescription of safety exclusions; and a description of the dosing plan,including duration, dose, or method to be used in determining dose. Inaddition, such protocols should specify in detail only those elements ofthe study that are critical to subject safety, such as: 1) necessarymonitoring of vital signs and blood chemistries and 2) toxicity-basedstopping or dose adjustment rules. In addition, the regulations state that modifications of the experimental design of Phase 1 studies that do notaffect critical safety assessments are required to be reported to FDAonly in the IND annual report.F.Chemistry, Manufacturing, and Control Information [21 CFR312.23(a)(7)]:The regulations at 312.23(a)(7)(i) emphasize the graded nature ofmanufacturing and controls information. Although in each phase of theinvestigation sufficient information should be submitted to assure theproper identification, quality, purity, and strength of the investigationaldrug, the amount of information needed to make that assurance will vary with the phase of the investigation, the proposed duration of theinvestigation, the dosage form, and the amount of information otherwiseavailable. For example, although stability data are required in all phases of the IND to demonstrate that the new drug substance and drug product are within acceptable chemical and physical limits for the plannedduration of the proposed clinical investigation, if very short-term tests are proposed, the supporting stability data can be correspondingly verylimited.It is recognized that modifications to the method of preparation of the new drug substance and dosage form, and even changes in the dosage form itself, are likely as the investigation progresses. The emphasis in an initial Phase 1 CMC submission should, therefore, generally be placed onproviding information that will allow evaluation of the safety of subjects in the proposed study. The identification of a safety concern or insufficientdata to make an evaluation of safety is the only basis for a clinical holdbased on the CMC section.Reasons for concern may include, for example: 1) a product made withunknown or impure components; 2) a product possessing chemicalstructures of known or highly likely toxicity; 3) a product that cannotremain chemically stable throughout the testing program proposed; or 4)a product with an impurity profile indicative of a potential health hazard oran impurity profile insufficiently defined to assess a potential health4hazard; or 5) a poorly characterized master or working cell bank.In addition, for pre-clinical studies to be useful in assuring the safety of human studies, sponsors should be able to relate the drug product being proposed for use in a clinical study to the drug product used in the animal toxicology studies that support the safety of the proposed human study. The information discussed in the following numbered paragraphs should usually suffice for a meaningful review of the manufacturing procedures for drug products used in Phase 1 clinical studies. Additional information should ordinarily be submitted for review of the larger-scale manufacturing procedures used to produce drug products for Phase 2 or Phase 3 clinical trials or as part of the manufacturing section of a marketing application. Any questions sponsors have about potential large scale IND clinical trials or potential marketing application manufacturing requirements or specifications should be directed to the appropriate division in the CDER Office of New Drug Chemistry, or the appropriate CBER division with responsibility for the product, for clarification and discussion. As clinical development of a drug product proceeds, sponsors should discuss the manufacturing data that will be needed to support the safe use of their products in Phase 2 and 3 trials with the appropriate division in the CDER Office of New Drug Chemistry, or the appropriate CBER division with responsibility for the product.1.Chemistry and Manufacturing Introduction:At the beginning of this section, the sponsor should state whetherit believes: 1) the chemistry of either the drug substance or thedrug product, or 2) the manufacturing of either the drug substance or the drug product, presents any signals of potential human risk.If so, these signals of potential risks should be discussed, and thesteps proposed to monitor for such risk(s) should be described, orthe reason(s) why the signal(s) should be dismissed should bediscussed.In addition, sponsors should describe any chemistry andmanufacturing differences between the drug product proposed forclinical use and the drug product used in the animal toxicologytrials that formed the basis for the sponsor's conclusion that it was safe to proceed with the proposed clinical study. How thesedifferences might affect the safety profile of the drug productshould be discussed. If there are no differences in the products,that should be stated.52.Drug Substance [312.23 (a)(7)(iv)(a)]:Sponsors are reminded that, under present regulations, references to the current edition of the USP-NF may be used to satisfy someof the requirements, when applicable.Information on the drug substance should be submitted in asummary report containing the following items.a. A description of the drug substance, including itsphysical, chemical, or biological characteristics:A brief description of the drug substance and someevidence to support its proposed chemical structure shouldbe submitted. It is understood that the amount of structureinformation will be limited in the early stage of drugdevelopment.b.The name and address of its manufacturer:The full street address of the manufacturer of the clinicaltrial drug substance should be submitted.c.The general method of preparation of the drugsubstance:A brief description of the manufacturing process, including alist of the reagents, solvents, and catalysts used, should besubmitted. A detailed flow diagram is suggested as theusual, most effective, presentation of this information.More information may be needed to assess the safety ofbiotechnology-derived drugs or drugs extracted from humanor animal sources.d.The acceptable limits and analytical methods used toassure the identity, strength, quality, and purity ofthe drug substance:A brief description of the test methods used should besubmitted. Proposed acceptable limits supported by simpleanalytical data, (e.g., IR spectrum to prove the identity, andHPLC chromatograms to support the purity level andimpurities profile) of the clinical trials material should be6provided. Submission of a copy of the certificate of analysisis also suggested. The specific methods will depend on thesource and type of drug substance (e.g., animal source,plant extract, radiopharmaceutic, other biotechnology-derived products). Validation data and establishedspecifications ordinarily need not be submitted at the initialstage of drug development. However, for some well-characterized, therapeutic biotechnology-derived products,preliminary specifications and additional validation data maybe needed in certain circumstances to ensure safety inPhase 1.rmation to support the stability of the drugsubstance during the toxicologic studies and theproposed clinical study(ies):A brief description of the stability study and the test methodsused to monitor the stability of the drug substance should besubmitted. Preliminary tabular data based onrepresentative material may be submitted. Neither detailedstability data nor the stability protocol should be submitted.3.Drug Product [21 CFR 312.23 (a)(7)(iv)(b)]:Sponsors are reminded that, under present regulations, references to the current edition of the USP-NF may be used to satisfy someof these requirements, when applicable.Information on the drug product should be submitted in a summary report containing the following items:a. A list of all components, which may includereasonable alternatives for inactive compounds, usedin the manufacture of the investigational drugproduct, including both those components intendedto appear in the drug product and those which maynot appear, but which are used in the manufacturingprocess:A list of usually no more than one or two pages of writteninformation should be submitted. The quality (e.g., NF,ACS) of the inactive ingredients should be cited. For novelexcipients, additional manufacturing information may be7necessary.b.Where applicable, the quantitative composition of theinvestigational new drug product, including anyreasonable variations that may be expected duringthe investigational stage:A brief summary of the composition of the investigationalnew drug product should be submitted. In most cases,information on component ranges is not necessary.c.The name and address of the drug productmanufacturer:The full street address(es) of the manufacturer(s) of theclinical trial drug product should be submitted.d. A brief, general description of the method ofmanufacturing and packaging procedures asappropriate for the product:A diagrammatic presentation and a brief written descriptionof the manufacturing process should be submitted, includingsterilization process for sterile products. Flow diagrams aresuggested as the usual, most effective, presentations of thisinformation.e.The acceptable limits and analytical methods used toassure the identity, strength, quality, and purity ofthe drug product:A brief description of the proposed acceptable limits and thetest methods used should be submitted. Tests that shouldbe submitted will vary according to the dosage form. Forexample, for sterile products, sterility and non-pyrogenicitytests should be submitted. Submission of a copy of thecertificate of analysis of the clinical batch is also suggested.Validation data and established specifications need not besubmitted at the initial stage of drug development. For well-characterized, therapeutic, biotechnology-derived products,adeaute assessment of bioactivity and preliminaryspecifications should be available.8rmation to support the stability of the drugsubstance during the toxicologic studies and theproposed clinical study(ies):A brief description of the stability study and the test methodsused to monitor the stability of the drug product packaged inthe proposed container/closure system and storageconditions should be submitted. Preliminary tabular databased on representative material may be submitted.Neither detailed stability data nor the stability protocolshould be submitted.4. A brief general description of the composition,manufacture, and control of any placebo to be used in theproposed clinical trial(s) [21 CFR 312.23(a)(7)(iv)(c)]:Diagrammatic, tabular, and brief written information should besubmitted.5. A copy of all labels and labeling to be provided to eachinvestigator [21 CFR 312.23(a)(7)(iv)(d)]:A mock-up or printed representation of the proposed labeling thatwill be provided to investigator(s) in the proposed clinical trialshould be submitted. Investigational labels must carry a "caution"statement as required by 21 CFR 312.6(a). That statement reads:"Caution: New Drug - Limited by Federal (or United States) law toinvestigational use."6. A claim for categorical exclusion from or submission of anenvironmental assessment [21 CFR 312.23(a)(7)(iv)(e)]:FDA believes the great majority of products should qualify for acategorical exclusion. Sponsors who believe their investigationalproduct meets the exclusion categories under 21 CFR 25.24should submit a statement certifying that their product meets theexclusion requirements and requesting a categorical exclusion onthat basis. (For INDs submitted to CDER, see Guidance forIndustry for the Submission of Environmental Assessments forHuman Drug Applications and Supplements, November, 1995.)9G.Pharmacology and Toxicology Information [21 CFR 312.23(a)(8)]:[The following pharmacology and toxicology guidance is applicable to allphases of IND development of products covered by this guidance.]1.Pharmacology and Drug Distribution [21 CFR312.23(a)(8)(i)]:This section should contain, if known: 1) a description of thepharmacologic effects and mechanism(s) of actions of the drug inanimals, and 2) information on the absorption, distribution,metabolism, and excretions of the drug. The regulations do notfurther describe the presentation of these data, in contrast to themore detailed description of how to submit toxicologic data. Asummary report, without individual animal records or individualstudy results, usually suffices. In most circumstances, five pagesor less should suffice for this summary. If this information is notknown, it should simply be so stated.To the extent that such studies may be important to address safetyissues, or to assist in evaluation of toxicology data, they may benecessary; however, lack of this potential effectiveness informationshould not generally be a reason for a Phase 1 IND to be placedon clinical hold.2.Toxicology: Integrated Summary [21 CFR312.23(a)(8)(ii)(a)]Present regulations require an integrated summary of thetoxicologic effects of the drug in animals and in vitro. Theparticular studies needed depend on the nature of the drug and thephase of human investigation. When species specificity,immunogenicity, or other considerations appear to make many orall toxicological models irrelevant, sponsors are encouraged tocontact the agency to discuss toxicological testing.The regulations are not specific as to the nature of the report oftoxicology data needed in an IND submission and the nature of thestudy reports upon which the report submitted to the IND is based.The regulations are silent on whether the submitted materialshould be based on: 1) "final fully quality-assured" individual studyreports, or 2) earlier, unaudited draft toxicologic reports of thecompleted study(ies). Most sponsors have concluded that a10submission based on final fully quality-assured individual study reports is required, and a substantial delay in submission of an IND for several months is often encountered to complete such final fully quality-assured individual reports from the time the unaudited draft toxicologic reports of the completed studies are prepared.Moreover, although the regulation does not specifically require individual toxicology study reports to be submitted, referring only to an integrated summary of the toxicologic findings, the requirement at 21 CFR 312.23(a)(8)(ii)(b) for a full tabulation of data from each study suitable for detailed review has led most sponsors to provide detailed reports of each study.Although the GLP and quality assurance processes and principles are critical for the maintenance of a toxicology study system that is valid and credible, it is unusual, as far as FDA is aware, for findings in the unaudited draft toxicologic report of the completed studies to change during the production of the "final," quality-assured individual study reports in ways important to determining whether use in humans is safe.Therefore, if final, fully quality-assured individual study reports are not available at the time of IND submission, an integrated summary report of toxicologic findings based on the unaudited draft toxicologic reports of the completed animal studies may be submitted. This integrated summary report should represent the sponsor's evaluation of the animal studies that formed the basis for the sponsor's decision that the proposed human studies are safe. It is expected that the unaudited draft reports that formed the basis of this decision might undergo minor modifications during final review and quality assurance auditing. Full toxicology department individual study reports should be available to FDA, upon request, and individual study reports should be available to FDA, upon request, as final, fully quality-assured documents within 120 days of the start of the human study for which the animal study formed part of the safety conclusion basis. These final reports should contain in the introduction any changes from those reported in the integrated summary. If there are no changes, that should be so stated clearly at the beginning of the final, fully quality-assured report.If the integrated summary is based upon unaudited draft reports,11sponsors should submit an update to their integrated summary by120 days after the start of the human study(ies) identifying anydifferences found in the preparation of the final fully quality-assured study reports and the information submitted in the initialintegrated summary. If there were no differences found, thatshould be stated in the integrated summary update..In addition, any new finding discovered during the preparation ofthe final, fully quality-assured individual study reports that couldaffect subject safety must be reported to FDA under 21 CFR312.32.Usually, 10 to 15 pages of text with additional tables (as needed)should suffice for the integrated summary. It should represent thesponsor's perspective on the completed animal studies at the timethe sponsor decided human trials were appropriate. Use of visualdata displays (e.g., box plots, stem and leaf displays, histogramsor distributions of lab results over time) will facilitate description ofthe findings of these trials.The summary document should be accurate contemporaneouslywith the IND submission (i.e., it should be updated so that if newinformation or findings from the completed animal studies havebecome known since the sponsor's decision that the proposedhuman study is safe, such new information should also be includedin the submitted summary).The integrated summary of the toxicologic findings of thecompleted animal studies to support the safety of the proposedhuman investigation should ordinarily contain the followinginformation:a. A brief description of the design of the trials and anydeviations from the design in the conduct of the trials. Inaddition, the dates of the performance of the trials should beincluded. Reference to the study protocol and protocolamendments may suffice for some of this information.b. A systematic presentation of the findings from the animaltoxicology and toxicokinetic studies. Those findings that aninformed and experienced expert would reasonablyconsider as possible signals of human risk should behighlighted. The format of this part of the summary may be12approached from a "systems review" perspective: (e.g.,CNS, cardiovascular, pulmonary, gastrointestinal, renal,hepatic, genitourinary, hematopoietic and immunologic, anddermal). If a product's effects on a particular body systemhave not been assessed, that should be so noted. If anywell-documented toxicological "signal" is not consideredevidence of human risk, the reason should be given. Inaddition, the sponsor should note whether these findingsare discussed in the investigator's brochure.c.Identification and qualifications of the individual(s) whoevaluated the animal safety data and concluded that it isreasonably safe to begin the proposed human study. Thisperson(s) should sign the summary attesting that thesummary accurately reflects the animal toxicology data fromthe completed studies.d. A statement of where the animal studies were conductedand where the records of the studies are available forinspection, should an inspection occur.e.As required under 21 CFR 312.23(a)(8)(iii), a declarationthat each study subject to good laboratory practices (GLP)regulations was performed in full compliance with GLPs or,if the study was not conducted in compliance with thoseregulations, a brief statement of the reason for thenoncompliance and the sponsor's view on how such non-compliance might affect the interpretations of the findings.NOTE: The information described in paragraphs "c", "d", and "e"may be supplied as part of the integrated summary or as part ofthe full data tabulations described below.3.Toxicology - Full Data Tabulation [21 CFR312.23(a)(8)(ii)(b)]:The sponsor should submit, for each animal toxicology study thatis intended to support the safety of the proposed clinicalinvestigation, a full tabulation of data suitable for detailed review.This should consist of line listings of the individual data points,including laboratory data points, for each animal in these trialsalong with summary tabulations of these data points. To allowinterpretation of the line listings, accompanying the line listings13。
中药新药申报资料要求
中药新药申报资料要求一、基本信息2.申报时间：填写正式申报的日期。
3.新药名称：填写中药新药的名称。
4.研发团队：填写负责研发的团队成员的基本信息。
二、药物研发情况1.研究目标：明确中药新药的研究目标，包括治疗的疾病、药效机制等。
2.研究背景：介绍中药新药研发的背景及其在相关领域的研究现状。
3.研究内容及方法：详细描述中药新药的研究内容和研究方法，包括药理学、药效学、制剂研发、临床试验等部分。
4.研究计划及进展：列出研究计划及已完成的研究进展情况，包括已完成的药物研发阶段、临床试验阶段等。
5.药物质量控制：描述中药新药的质量控制体系和主要指标，包括药材选用、提取工艺、质量标准等。
三、临床试验资料1.临床试验设计：详细描述临床试验的设计方案，包括试验设计、入选标准、排除标准、样本大小计算等。
2.试验药物：提供试验药物的质量标准、制剂、用法用量等信息。
3.临床试验方案：提供临床试验的操作规范、纳入条件、排除条件等信息。
4.临床试验结果：提供已完成的临床试验结果，包括对照组比较、主要指标的分析等。
四、安全性评价1.不良反应报告：提供临床试验过程中出现的不良反应的报告及分析。
2.毒理学评价：提供对药物毒性的评价结果，包括化学毒理学、急性毒性等。
3.药物相互作用：提供药物相互作用的评价结果，包括与其他药物的相互作用、药物代谢的影响等。
五、药物说明书1.药物说明书：提供中药新药的说明书，包括药物适应症、用法用量、不良反应、禁忌症等信息。
六、其他相关资料1.中药新药专利：提供中药新药的专利文件或专利申请材料。
2.发明创造性证明：提供中药新药的研发过程中的发明创造性证明文件。
3.相关文献：提供与中药新药研发相关的科学文献、研究报告等资料。
4.其他相关文件：提供申请所需的其他相关文件。
以上是申报中药新药所需的基本资料要求，请按照要求提供详细的资料，以便审查和评估。
新药Ⅰ期临床试验申报资料的内容及格式要求
新药Ⅰ期临床试验申报资料的内容及格式要求1995年11月美国FDA发布2009年6月药审中心组织翻译诺华制药有限公司翻译北核协会审核药审中心最终核准目录I. II. III. 引言 (1)现行要求与操作规范 (2)现行新药临床申请法规的解释 (2)A. 封面（FDA格式-1571）[21 CFR 312.23（a）（1）]: (2)B. 目录[21 CFR 312.23（a）（2）]: (2)C. 介绍性声明与整体研究方案[21 CFR 312.23（a）（3）]： (2)D. 研究者手册[21 CFR 312.23（a）（5）]: (2)E. 方案[21 CFR 312.23（a）（6）]: (2)F. 化学、生产和控制信息[21 CFR 312.23（a）（7）]: (3)G. 药理学和毒理学信息[21 CFR 312.23（a）（8）]： (6)H. 研究药物既往在人体中使用的经验[21 CFR 312.23（a）（9）]： (9)I. 21 CFR 312.23（a）（10）、（11）（b）、（c）、（d）（e）： (10)新药Ⅰ期临床试验申报资料的内容及格式要求I. 引言随着近期FDA成功实现《1992年处方药付费法》（PDUFA）审评行动的目标，使得从递交上市注册申请至批准上市的平均时间和中位时间均显著缩短。
FDA已将注意力转移至如何提高药品开发过程中其它部分的效率，同时保证这种效率的提高不得以牺牲美国人所期望获得的、具备长期安全性和有效性药品的标准为代价。
其中有一个IND法规特别值得关注，即关于在人体中开始进行药物试验的法规（即Ⅰ期试验），自McMahon 行动会议以来，对此课题已经进行了两年多的积极讨论，并且吸纳了各方不同层次的意见。
本指导原则阐述了在美国将研究药品（包括已进行结构确证的治疗性生物工程类产品）开始用于人体研究时，所需要提供的数据和在21 CFR 312.22和312.23中需要报告的数据1。
中药新药研发申报流程及相关材料说明
中药新药研发申报流程及相关申报材料说明一、中药新药的注册分类及说明1.1注册分类中药新药注册按审批管理的要求分以下几类：1.未在国内上市销售的从植物、动物、矿物等物质中提取的有效成份及其制剂。
2.新发现的药材及其制剂。
3.新的中药材代用品。
4.药材新的药用部位及其制剂。
5.未在国内上市销售的从植物、动物、矿物等物质中提取的有效部位及其制剂。
6.未在国内上市销售的中药、天然药物复方制剂。
7.改变国内已上市销售中药、天然药物给药途径的制剂。
8.改变国内已上市销售中药、天然药物剂型的制剂。
9.仿制药。
1.2说明注册分类1-6的品种为新药，注册分类7、8按新药申请程序申报，注册分类9的品种为已有国家标准的药品。
二、中药新药的研发及申报流程中药新药的研发申报一般按以下程序进行:选题立项——临床前研究——临床研究——申报审批——正式生产，其中，新药临床前及临床研究的主要内容及注意事项分别列举如下:2.1 新药的临床前研究（一）主要内容：新药的临床前研究主要包括制备工艺（中药制剂包括原药材的来源、加工及炮制）、理化性质、纯度、检验方法、处方筛选、剂型、稳定性、质量标准、药理、毒理、动物药代动力学等研究。
新发现中药材还应包括来源、生态环境、栽培（养殖）技术、采收处理、加工炮制等研究。
（二）注意事项：从事新药安全性研究的实验室应符合国家药品监督管理局《药品非临床研究质量管理规范》（GLP）的相应要求，实验动物应符合国家药品监督管理局的有关要求，以保证各项实验的科学性和实验结果的可靠性。
2.2 新药的临床研究（一）主要内容：新药的临床研究包括临床试验和生物等效性试验。
新药的临床试验分为Ⅰ、Ⅱ、Ⅲ、Ⅳ期。
Ⅰ期临床试验：初步的临床药理学及人体安全性评价试验。
观察人体对于新药的耐受程度和药物代谢动力学，为制定给药方案提供依据。
Ⅱ期临床试验：随机盲法对照临床试验。
对新药有效性及安全性作出初步评价，推荐临床给药剂量。
Ⅲ期临床试验：扩大的多中心临床试验。
新药注册申报资料 引用资料-概述说明以及解释
新药注册申报资料引用资料-概述说明以及解释1.引言1.1 概述本文旨在探讨新药注册申报资料的引用资料，着重介绍了新药注册申报流程以及资料的要点。
随着科技的不断进步和医学的不断发展，新药的研发和注册申报变得愈发重要。
注册申报是新药上市的必经之路，它要求研发者提交详尽的资料来证明新药的安全性和有效性。
而在申报过程中，引用其他资料是一种常见的做法。
这些资料可以是已有的研究报告、医学期刊文章、相关专利等。
本文将从以下几个方面阐述新药注册申报资料的引用，包括引用的意义、引用的原则、引用的方式以及引用的注意事项。
同时还将结合实例，说明资料的引用如何在新药注册申报中起到支撑和强化数据的作用。
通过对新药注册申报资料的引用资料进行研究，我们可以更好地理解新药注册申报的要求与标准，提高新药注册申报的质量和效率。
希望本文能够对正在进行新药注册申报的研发者提供参考和帮助，也能够引起更多人对新药研究和申报的关注，为医疗健康事业的进步作出贡献。
1.2 文章结构文章结构部分将对整篇长文的组织和布局进行介绍。
本文共分为三个主要部分：引言、正文和结论。
首先是引言部分。
在引言的概述中，将简要介绍新药注册申报资料以及其在药物研发中的重要性和影响。
接着，将说明文章的整体结构，提供读者对文章内容的预期和概述。
最后，明确本文的目的，即在于全面阐述新药注册申报资料的要点和流程，以及提出相关的建议和展望。
接下来是正文部分。
在药物研发背景中，将探讨目前药物研发领域的发展状况和趋势，包括新药的研究方向和创新点等。
在新药注册申报流程中，将详细介绍新药的注册申报流程，包括药物的实验室研究、临床试验、生产和制造等环节。
在新药注册申报资料要点部分，将列举新药注册申报所需提交的相关资料要点，包括药物的化学成分、药理学研究、药物安全性评价等。
最后是结论部分。
在总结中，将简明扼要地总结文章的主要内容，强调新药注册申报资料的重要性和必要性。
在对新药注册申报的建议部分，将提出一些建议，以优化新药注册申报的流程和资料的准备，进一步提高新药注册的效率和质量。
1类新型兽药申报材料
1类新型兽药申报材料
针对申报新型兽药的材料，以下是一些常见的内容和要求：
1. 申请表格，通常需要填写申请表格，包括申请人的基本信息、兽药的名称、成分、适应症、用法用量等详细信息。
2. 药物成分和制备方法，需要提供兽药的成分及其含量，以及
制备方法的详细说明。
这包括药物的主要活性成分和辅助成分。
3. 质量控制，需要提供兽药的质量控制标准，包括物理性质、
化学性质、药效学和稳定性等方面的测试方法和要求。
4. 药理学和毒理学研究，需要提供兽药的药理学和毒理学研究
结果，包括药物在动物体内的吸收、分布、代谢和排泄等方面的数据。
5. 安全性评价，需要提供兽药的安全性评价结果，包括急性毒性、亚慢性毒性、致癌性、致畸性等方面的研究数据。
6. 临床试验，需要提供兽药的临床试验结果，包括药效学、安
全性和用法用量等方面的数据。
临床试验需要符合相关伦理和法规要求。
7. 包装和标签，需要提供兽药的包装和标签设计，包括药物的名称、成分、规格、生产日期、有效期、用法用量、适应症、禁忌症、注意事项等信息。
8. 生产工艺和质量管理，需要提供兽药的生产工艺流程和质量管理体系，确保兽药的生产过程符合相关法规和标准。
以上是一般申报新型兽药所需的材料，具体要求可能会因国家或地区的法规和标准而有所不同。
申请人在准备申报材料时，应仔细阅读相关法规和指南，并严格按照要求提供所需的信息和数据。
药物临床试验申请报告
药物临床试验申请报告
药物临床试验机构：
专业申请参加：
本专业确定作为该试验项目的负责人，作为
该试验项目的质控员，为该试验项目的药品专管员。
本项目的负责人及质控员已阅读并熟悉该项目的相关资料，同意执行试验方案中所有细节，确保参加项目的其他研究人员在试验过程遵守临床试验方案。
本专业具备完成该临床试验的医疗条件，有足够的病例资源，可以在规定的时间内、在符合GCP等法律法规的前提下按临床试验方案要求完成该项工作。
专业负责人签字：
日期：。
新药I期临床试验申请技术指南（草案）
新药I期临床试验申请技术指南（草案）新药I期临床试验申请技术指南(草案）国家食品药品监督管理总局(CFＤA）2016年９月1目录一、前言.................................................................................................. １二、背景.................................................................................................. ２三、与药审中心沟通交流 (3)四、IＮD提交所需的特定信息?4（一)规定的表格......................................................................................... ４(二)?文件目录 (5)（三)介绍性说明和总体研究计划?5(四)?研究者手册 (6)（五)方案?8(六）化学、生产和控制信息?9(七）药理毒理信息?１４（八）研究药物既往在人体使用的经验?1617（九）其他重要信息?(十)相关信息.................................................................................................... １７17五、提交信息?六、INＤ过程和审评过程 (18)19(一)临床试验暂停要求?(二）?ＩNＤ修订............................................................................................... ２1 122七、申请人的其他责任?22(一)?遵守法规伦理要求?(二)监测正在进行的研究.................................................................................. ２2(三)研究药物的推销或付费?2３（四)记录和报告 ............................................................................................. ２３(五)INＤ安全性报告.......................................................................................... ２3(六)IND年度报告.............................................................................................. 2４八、撤回、终止、暂停或者重新启动ＩND?2５附件 (27)附件1:药品注册临床试验申报资料信息表 .................................................... 2７30附件２：研究者声明表?附件3:化药Ⅰ期临床研究CMC资料表?332新药I期临床试验申请技术指南一、前言国家食品药品监督管理总局（CFDＡ)发布本技术指南旨在帮助新药研发申请人提交足够的临床试验研究申请（Inｖestigatioｎａl nｅｗdrｕg，IＮＤ)材料，以提高新药研发与审评效率，并同时能保证药品的安全性、有效性和质量可控性。
新药Ⅰ期临床试验申报资料的内容与格式要求内容
新药Ⅰ期临床试验申报资料的容及格式要求1995年11月美国FDA发布2009年6月药审中心组织翻译诺华制药有限公司翻译北核协会审核药审中心最终核准目 录I.II. III. 引言 .........................................................................................................................1 现行要求与操作规 ............................................................................. (2)现行新药临床申请法规的解释 (2)A. 封面（FDA 格式-1571）[21 CFR 312.23（a ）（1）]: (2)B. 目录[21 CFR 312.23（a ）（2）]: (2)C. 介绍性声明与整体研究方案 [21 CFR 312.23（a ）（3）]： (2)D. 研究者手册 [21 CFR 312.23（a ）（5）]: (2)E. 方案 [21 CFR 312.23（a ）（6）]: (2)F. 化学、生产和控制信息 [21 CFR 312.23（a ）（7）]: (3)G. 药理学和毒理学信息 [21 CFR 312.23（a ）（8）]： (6)H. 研究药物既往在人体中使用的经验 [21 CFR 312.23（a ）（9）]： (9)I. 21 CFR 312.23（a ）（10）、（11）（b ）、（c ）、（d ）（e ）： (10)新药Ⅰ期临床试验申报资料的容及格式要求I. 引言随着近期FDA成功实现《1992年处方药付费法》（PDUFA）审评行动的目标，使得从递交上市注册申请至批准上市的平均时间和中位时间均显著缩短。
FDA已将注意力转移至如何提高药品开发过程中其它部分的效率，同时保证这种效率的提高不得以牺牲美国人所期望获得的、具备长期安全性和有效性药品的标准为代价。
化药新药1类申报流程、研究内容及要求
化药新药1类申报流程、研究内容及要求下载温馨提示:该文档是我店铺精心编制而成，希望大家下载以后，能够帮助大家解决实际的问题。
文档下载后可定制随意修改，请根据实际需要进行相应的调整和使用，谢谢!并且，本店铺为大家提供各种各样类型的实用资料，如教育随笔、日记赏析、句子摘抄、古诗大全、经典美文、话题作文、工作总结、词语解析、文案摘录、其他资料等等，如想了解不同资料格式和写法，敬请关注!Download tips: This document is carefully compiled by theeditor.I hope that after you download them,they can help yousolve practical problems. The document can be customized andmodified after downloading,please adjust and use it according toactual needs, thank you!In addition, our shop provides you with various types ofpractical materials,such as educational essays, diaryappreciation,sentence excerpts,ancient poems,classic articles,topic composition,work summary,word parsing,copy excerpts,other materials and so on,want to know different data formats andwriting methods,please pay attention!化药新药1类申报流程、研究内容及要求详解化药新药1类，也被称为创新药，是指未曾在中国境内上市销售的化学药品。
新药I期临床试验申请技术指南
新药I期临床试验申请技术指南一、背景与目的：新药I期临床试验是新药研发的第一个阶段，目的是评估药物的药代动力学特性、药效学特性和耐受性，以确定药物的合理剂量和给药方案，并初步评估其治疗效果和安全性。
本技术指南旨在提供新药I期临床试验申请的相关技术要求和指导。
二、申请材料：1.临床试验药物信息：包括药物的命名、化学结构、物理化学性质、质量规格等；2.临床试验计划书：详细描述试验设计、纳入标准、排除标准、剂量选择、给药方案、随访计划等；3.试验药物处方信息：根据相关法规和规定提供试验药物的处方格式，包括药物名称、规格、用法、用量等；4.试验药物生产、质量控制和储存情况：提供药物的生产过程、质量控制标准和方法，以及药物的储存条件和期限；5.试验计划实施能力：提供研究者团队的相关资格证明和研究设施的评估报告；6.试验受试者招募和知情同意：提供试验受试者招募计划和知情同意书的样本；7.预期试验结果和安全性评价：提供预期试验结果和安全性的评价，包括预计的不良事件和副作用，并提供监测和报告计划。
三、技术要求：1.试验设计：明确试验的目标、纳入和排除标准、随机方法、对照组设计等，确保试验结果的可靠性和可比性；2.试验药物剂量选择和给药方案：根据预期的药效学特性和药代动力学特性，选择合适的剂量范围和给药途径，并制定详细的给药方案；3.试验受试者安全保障：确保参与试验的受试者的安全和福利，包括对不良事件的监测和评估，以及适时的疾病治疗；4.试验过程控制：确保试验过程的准确性和可追溯性，包括试验药物使用记录、试验数据的收集和管理，以及试验所需设备和设施的质量控制；5.试验结果分析和解释：对试验结果进行合理的统计分析和解释，确保结果的真实可靠性和科学性；6.试验报告和沟通：根据临床试验的相关法规和规定编写试验报告，并与相关部门和机构进行有效的沟通，诚信地提交试验结果和相关数据。
四、其他注意事项：1.临床试验应遵守当地和国际相关法规和伦理准则，确保试验的科学性、伦理性和安全性；2.临床试验应严格保护试验受试者的隐私和个人信息，确保试验过程的合法性和合规性；3.临床试验应进行充分的试验前准备工作，包括研究者的培训和试验设施的准备；4.临床试验的相关数据应进行严格的质量控制和管理，确保数据的准确性和可靠性；5.临床试验应建立有效的监管和审核机制，确保试验过程和结果的合规性和安全性；6.相关研究机构和人员应具备相关的执业资质和研究能力，确保试验的科学性和可靠性；7.临床试验结果应及时向相关部门和机构进行报告和沟通，确保试验结果的公正和透明。
新药I期临床试验申请技术指南(草案)
新药I期临床试验申请技术指南(草案）国家食品药品监督管理总局(CFＤA）2016年９月1目录一、前言.................................................................................................. １二、背景.................................................................................................. ２三、与药审中心沟通交流 (3)四、IＮD提交所需的特定信息ﻩ4（一)规定的表格......................................................................................... ４(二)ﻩ文件目录 (5)（三)介绍性说明和总体研究计划ﻩ5(四)ﻩ研究者手册 (6)（五)方案ﻩ8(六）化学、生产和控制信息ﻩ9(七）药理毒理信息ﻩ１４（八）研究药物既往在人体使用的经验ﻩ1617（九）其他重要信息ﻩ(十)相关信息.................................................................................................... １７17五、提交信息ﻩ六、INＤ过程和审评过程 (18)19(一)临床试验暂停要求ﻩ(二）ﻩＩNＤ修订............................................................................................... ２1122七、申请人的其他责任ﻩ22(一)ﻩ遵守法规伦理要求ﻩ(二)监测正在进行的研究.................................................................................. ２2(三)研究药物的推销或付费ﻩ2３（四)记录和报告 ............................................................................................. ２３(五)INＤ安全性报告.......................................................................................... ２3(六)IND年度报告.............................................................................................. 2４八、撤回、终止、暂停或者重新启动ＩNDﻩ2５附件 (27)附件1:药品注册临床试验申报资料信息表 .................................................... 2７30附件２：研究者声明表ﻩ附件3:化药Ⅰ期临床研究CMC资料表ﻩ332新药I期临床试验申请技术指南一、前言国家食品药品监督管理总局（CFDＡ)发布本技术指南旨在帮助新药研发申请人提交足够的临床试验研究申请（Inｖestigatioｎａl nｅｗdrｕg，IＮＤ)材料，以提高新药研发与审评效率，并同时能保证药品的安全性、有效性和质量可控性。
新药I期临床试验申请技术指南
新药I期临床试验申请技术指南一、概述新药的临床试验是保证其安全性和有效性的重要环节，I期临床试验是指在人体体内进行的首次试验，主要目的是确定药物的安全性和耐受性，并初步了解药物的药代动力学特征。
本技术指南旨在指导申请人提交I期临床试验申请，确保试验的科学性和合规性。
二、申请材料1.申请书：包括试验目的、设计、试验计划、样本分析方法等内容。
2.药物化学和药物制剂方面的相关资料：包括药物化学实验室和制剂实验室合格报告、药物品质状况评估等。
3.动物试验数据：包括毒性实验、药动学、药效学等数据。
4.质量控制和生产情况：包括制剂质量控制、生产工艺和质量控制规范等。
5.试验人员相关信息：包括相关专业背景、从业资格及经验等。
三、试验设计1.受试者选择：要求合适的受试者特征，如年龄、性别、健康状况等。
2.样本量确定：要求基于科学统计方法确定样本量，以保证试验结果的统计学意义。
3.随机分组和盲法：要求采用随机分组和双盲方法，以减少实验结果的偏倚。
4.试验组和对照组：要求明确区分试验组和对照组，对照组使用安慰剂或基线治疗。
5.试验方案和观察指标：要求明确试验方案和观察指标，包括药物给予剂量、给药途径、给药频率、观测时间点等。
四、试验过程1.试验药物管理：要求严格按照试验方案给予药物，并记录药物给予情况和不良事件。
2.试验数据记录和统计：要求记录试验数据和不良事件，保证数据的可靠性和一致性。
3.药物浓度测定：要求采用准确的分析方法测定药物浓度，确保药物浓度的准确性。
4.不良事件的处理：要求及时记录不良事件，并采取适当的处理措施。
如有需要，应停止试验并报告监管部门。
5.试验完结和总结：要求试验完结后进行数据总结和分析，并撰写试验报告。
五、伦理与合规1.受试者知情同意：要求征得受试者的知情同意，并确保其随时可以终止试验。
2.试验伦理审查：要求按照相关法规进行伦理审查，确保试验符合伦理原则和道德要求。
3.守信承诺和保密：要求申请人保证试验数据的保密性和互相守信，防止数据泄露和误用。
新药I期临床试验申请技术指南(草案)
新药I期临床试验申请技术指南食品药品监督管理总局（CFDA）2016年9月一、前言..................................................... 1……二、背景..................................................... 2••…三、与药审中心沟通交流...................................... 3…四、I ND提交所需的特定信息................................... 4…（一）规定的表格................................................ 4 ..............（二）文件目录.................................................. 4 ..............（三）介绍性说明和总体研究计划.................................. 5. .........（四）研究者手册............................................... 6 ..............（五）方案...................................................... .8. ............（六）化学、生产和控制信息..................................... 9 ..........（七）药理毒理信息 (13)（八）研究药物既往在人体使用的经验 (16)（九）其他重要信息 (16)（十）相关信息 (17)五、提交信息 (17)六、IND 过程和审评过程 (17)（一）临床试验暂停要求 (19)（二）IND 修订 (20)七、申请人的其他责任 (21)（一） ..................................................... 遵守法规伦理要求21（二） ................................................... 监测正在进行的研究22（三） .................................................... 研究药物的推销或付费22（四） ............................................................ 记录和报告22（五） ......................................................... I ND安全性报告23（六） ........................................................... I ND年度报告23八、撤回、终止、暂停或者重新启动IND (24)附件 (26)附件1:药品注册临床试验申报资料信息表 (26)附件2:研究者声明表 (29)附件3:化药I期临床研究CMC资料表 (32)新药I期临床试验申请技术指南一、前言食品药品监督管理总局（CFDA ）发布本技术指南旨在帮助新药研发申请人提交足够的临床试验研究申请（Investigational new drug ，IND）材料，以提高新药研发与审评效率，并同时能保证药品的安全性、有效性和质量可控性。
新药I期临床试验申请技术指南20240930
新药I期临床试验申请技术指南20240930一、引言新药研发是保障人民健康的重要工作，I期临床试验是新药研发过程中的重要环节。
为了规范和指导I期临床试验申请工作，制定本技术指南。
二、I期临床试验概述1.I期临床试验是新药研发的第一阶段，目的是评估新药的安全性和耐受性。
2.I期临床试验的实施必须符合伦理要求，并严格遵守药物管理法律法规。
三、I期临床试验申请材料准备1.申请人需在申请I期临床试验前，详细了解试验药物的性质、已有的非临床试验结果以及人体试验的风险与益处。
2.申请材料包括新药临床试验申请报告和新药质量状况报告等。
四、试验设计与方法1.I期临床试验的设计应遵循国际通行的原则和规范，如随机对照、安慰剂对照等。
2.试验目标人群应根据药物特性及预计的治疗效果确定，且应确保试验人员的知情同意。
3.试验的安全与监测计划应根据试验药物的特性和已知的不良反应确定，包括实施严格的不良事件报告和监测。
五、试验干预措施和测量指标1.试验干预措施应明确，包括药物剂量、给药途径等。
2.测量指标应与试验目的相符，可包括生化指标、疗效评价指标等。
六、试验计划执行1.试验应在专业的医疗机构或研究机构进行，试验人员应具备相关资质和技术。
2.试验期间应对试验人员进行核查和培训，以确保试验的严谨性和准确性。
七、试验风险与安全措施1.试验主体应提前评估试验人员可能面临的风险，并提供相关的安全措施。
2.在试验期间，应有专业的安全监测团队负责试验人员的安全监测和风险评估。
八、数据统计与分析1.试验数据的收集应遵循规定的流程和标准，确保数据的完整性和准确性。
2.数据的统计与分析应由专业的统计学家进行，遵循规定的统计学原则。
九、I期临床试验结果报告1.I期临床试验结果报告应提供详细的数据和分析结果，以及结论和讨论部分。
2.报告应完整、准确地反映试验结果，不得歪曲或隐瞒试验结果。
十、总结与展望本技术指南的制定旨在规范和指导新药I期临床试验申请工作，并为保障人民的健康提供科学依据。
FDA NDA新药Ⅰ期临床试验申报资料
新药Ⅰ期临床试验申报资料的内容及格式要求1995年11月美国FDA发布2009年6月药审中心组织翻译诺华制药有限公司翻译北核协会审核药审中心最终核准目录I. 引言 (1)II. 资料内容和格式 (1)A. 封面 (1)B. 目录 (1)C. 介绍性声明与整体研究计划 (1)D. 研究者手册 (2)E. 研究方案 (2)F. 化学、生产和控制信息 (2)G. 药理毒理信息 (5)H. 研究药物既往在人体中使用的经验 (6)I. 其他相关说明 (6)新药Ⅰ期临床试验申报资料的内容及格式要求I. 引言美国FDA于1995年11月颁布了《GUIDANCE FOR INDUSTRY：CONTNET AND FORMAT OF INVESTIGATIONAL NEW DRUG APPLICATIONS（IND）FOR PHASE 1 STUDIES OF DRUGS，INCLUDING WELL-CHARACTERIZED，THERAPEUTIC，BIOTECHNOLOGY-DERIVED PRODUCTS》，为进一步促进我国新药研发和审评能力的提高，本指导原则系在参考FDA上述指导原则的基础上，结合我国《药品注册管理办法》的相关要求，经翻译转化，以指导、规范我国新药I期临床试验申报资料的内容及格式要求。
本指导原则阐述了将研究药物（包括已进行结构确证的治疗性生物工程类产品）申请用于人体研究时，所需要提供的资料内容和格式要求1。
按照《药品注册管理办法》，属注册分类1和2的药品，应当进行临床试验。
在满足我国现行法规对申报临床试验资料要求的基础上，按照药物研究阶段的不同，将申报资料的要求加以分类，将有助于加速新药批准进入临床试验的时间。
对于拟进行I期临床试验的注册申请，所提交的申报资料应能够满足安全性评价的需要，其中最重要的两部分内容包括：1）毒理学研究汇总报告，基于已完成的动物研究结果，为人体研究提供初步的支持依据；2）适合于I期临床试验研究用样品的制备资料。
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附件3
新药Ⅰ期临床试验申请申报资料
一、申报资料基本要求
申请人应参照《新药I期临床试验申请技术指南》（国家食品药品监督管理总局通告2018年第16号），提供下述资料：
1.文件目录；
2.介绍性说明和总体研究计划；
3.研究者手册；
4.临床试验方案或草案；
5.药学研究信息；
6.非临床研究信息；
7.既往临床使用经验说明；
8.境外研究资料。
同时，还应提供如下信息：
1.药物警戒系统建立情况；
2.临床试验相关方名录；
3.伦理委员会审查相关资料；
4.申报前沟通交流资料。
二、申报资料重点关注
重点关注如下内容：
1.临床试验方案的完整性、科学性和可操作性。
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2.支持性研究数据的充分性。
鼓励采用CTD格式，提交包括药学研究、非临床研究、境外或早期临床研究等支持性研究数据。
除了综述和总结部分外，应提供完整的各专业研究报告。
3.申报前沟通交流情况。
应提供沟通交流会议纪要（如有），以及根据纪要精神相关研究的完成情况。
4.受试者安全性风险控制。
应根据临床研发计划和临床试验方案，说明药物安全委员会和构建药物警戒系统的组建情况。
5.临床试验利益相关方。
应提供包括研究者姓名和资质、主要研究机构、独立数据监察委员会等在内的临床试验相关方名录信息。