药物研发与技术审评沟通交流管理办法

云南省药品监督管理局关于印发《云南省药品审评审批沟通交流办法》的通知正文：---------------------------------------------------------------------------------------------------------------------------------------------------- 云南省药品监督管理局关于印发《云南省药品审评审批沟通交流办法》的通知云药监注〔2020〕13号各州、市市场监督管理局，省药品和医疗器械审评中心：为贯彻落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》、云南省人民政府《关于改革药品医疗器械审评审批制度的实施意见》、中共云南省委办公厅云南省人民政府办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的实施意见》，进一步深化“放管服”改革，云南省药品监督管理局研究制定了《云南省药品审评审批沟通交流办法》，现印发给你们，请遵照执行。

云南省药品监督管理局2020年3月18日云南省药品审评审批沟通交流办法第一条为贯彻落实中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》、云南省人民政府《关于改革药品医疗器械审评审批制度的实施意见》、中共云南省委办公厅云南省人民政府办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的实施意见》，进一步深化“放管服”改革，加强与申请人之间的沟通交流，依据《药品注册管理办法》等相关法律法规，制定本办法。

第二条本办法所指的沟通交流，系指云南省境内药品注册申请受理前和审评审批阶段，经申请人提出，由云南省药品监督管理局（以下简称省局）相关部门及直属单位组织的与申请人就注册申请事项所进行的沟通交流，主要适用于省级药品监管部门批准的药品注册申请事项的沟通交流。

第三条对于国家药品监督管理局（以下简称国家局）批准的药品注册申请事项，省局结合自身职能职责以及申请人咨询内容，给予必要的指导和建议，相关程序可参照本办法执行。

中药新药研究过程中沟通交流会议药学资料要求的指导原则（征求意见稿）2020年07月目录一、概述 (1)二、基本要求 (1)三、沟通交流会议药学资料要求 (2)（一）药物临床试验申请前会议 (2)1. 药物研究概况和药学研究资料 (2)2. 拟讨论问题 (3)（二）药物Ⅱ期临床试验结束/Ⅲ期临床试验启动前会议 (3)1.药物研究概况和药学研究资料 (4)2.拟讨论问题 (4)（三）药品上市许可申请前会议 (5)1.药物研究概况和药学研究资料 (5)2.拟讨论问题 (5)（四）其他会议 (6)四、参考文献 (6)五、著者 (7)中药新药研究过程中沟通交流会议药学资料要求的指导原则（征求意见稿）一、概述1沟通交流是申请人与国家药品审评机构解决研发问题2的有效方式，有利于解决中药新药研究及审评中存在的问题，3加速新药研发进程，促进中药传承创新。

为规范沟通交流会4议的药学资料，提高沟通交流的质量和效率，根据中药特点、5中药新药研发规律和沟通交流制度的相关规定，制定本指导6原则。

7本指导原则适用于中药新药研发过程中沟通交流会议8的药学资料，重点针对药物临床试验申请前、药物Ⅱ期临床9试验结束/Ⅲ期临床试验启动前、药品上市许可申请前的沟通10交流会议。

其他沟通交流会议的中药药学资料要求可参考。

11沟通交流会议的程序等参照国家药品审评机构相关会12议要求。

中药新药药学研究内容可参考相关指导原则和技术13要求。

14二、基本要求15坚持以问题为导向的基本原则，明确拟讨论问题。

申请16人应根据现行指导原则和技术要求等进行深入思考和充分17研究，围绕问题提供相关的背景信息、详实的研究资料和拟18解决方案，提供的资料同时应符合相关会议资料要求，以便19提高沟通交流的质量和效率，达到沟通交流会议的预期目的。

20申请人应基于不同研发阶段，提供相应的药学研究资料，21以便更好地评估已有研究数据是否支持拟开展的各期临床22试验、临床试验受试者安全风险是否可控、是否支持药品上23市许可的技术要求等。

药品注册审评一般性技术问题咨询管理规范第一章总则 .................................................................. - 1 - 第二章工作流程............................................................... - 2 - 第三章工作要求............................................................... - 3 - 第四章附则 .................................................................. - 4 -第一章总则第一条为贯彻《国务院关于改革药品医疗器械审评审批制度的意见》（国发〔2015〕44号）精神，落实国家食品药品监督管理总局《药物研发与技术审评沟通交流管理办法（试行）》（2016年第94号）要求，进一步加强药品技术审评咨询工作，优化技术咨询程序，提高药品审评技术咨询服务质量和效率，制定本规范。

第二条本规范所指的一般性技术问题咨询（以下简称“咨询问题”）是指：申请人和药品审评中心（以下简称“药审中心”）之间通过药审中心官网（）的“申请人之窗”就一般性技术问题进行交流咨询。

该沟通交流方式通常不就技术审评过程中的重大决策性问题进行讨论。

咨询问题包括与中心职能相关的技术审评问题及相关管理问题，涉及保密的问题不属于一般性技术问题。

一般性技术问题咨询的反馈意见基于当前政策法律法规规章等规范性文件和技术要求做出，可能会随政策法律法规规章等规范性文件或技术要求的变化而变化。

如果总局就相关问题做出解释或解答，以总局的解释或解答为准。

第三条业务管理处负责咨询问题的接收、分配、意见形成及反馈的总体协调管理，业务管理处项目管理人根据任务分工开展具体协调管理工作，中心其他相关部门配合完成此项工作。

国家药品监督管理局关于调整药物临床试验审评审批程序的公告（2018年第50号）2018年07月27日发布为鼓励创新，加快新药创制，满足公众用药需求，落实申请人研发主体责任，依据中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字〔2017〕42号），对药物临床试验审评审批的有关事项作出调整：在我国申报药物临床试验的，自申请受理并缴费之日起60日内，申请人未收到国家食品药品监督管理总局药品审评中心（以下简称药审中心）否定或质疑意见的，可按照提交的方案开展药物临床试验。

现就具体事宜公告如下：一、沟通交流会议的准备与申请（一）申请人在提出新药首次药物临床试验申请之前，应向药审中心提出沟通交流会议申请，并在确保受试者安全的基础上，确定临床试验申请资料的完整性、实施临床试验的可行性。

（二）申请人准备的沟通交流会议资料应包括临床试验方案或草案、对已有的药学和非临床研究数据及其他研究数据的完整总结资料。

申请人应自行评估现有的研究是否符合申报拟实施临床试验的基本条件，并明确拟与药审中心讨论的问题。

（三）申请人应按照《药物研发与技术审评沟通管理办法（试行）》（以下简称《沟通交流办法》）要求，提交沟通交流会议申请表（附件1）。

药审中心应及时通知申请人是否召开沟通交流会议，并与申请人商议会议时间。

申请人应按沟通交流相关要求按时提交完整的沟通交流会议资料（附件2）。

药审中心对沟通交流会议资料进行初步审评，在沟通交流会议召开至少2日前，通过“申请人之窗”将初步审评意见和对申请人所提出问题的解答意见告知申请人。

申请人在收到初步审评意见和解答意见后，应尽快反馈问题是否已经得到解决。

申请人认为问题已经解决不需要召开沟通交流会议的，应通过药审中心网站“申请人之窗”告知药审中心取消沟通交流会议申请；申请人认为申请沟通交流的问题仍未得到解决的，按原定计划继续组织会议召开。

二、沟通交流会议的召开（四）会议由药审中心工作人员主持，双方围绕药物临床试验方案就申请人提出的关键技术问题，以及已有资料和数据是否支持实施临床试验开展和受试者安全风险是否可控进行讨论，并为后续研究提出要求和建议。

附件化学药品创新药I期临床试验申请药学共性问题相关技术要求为鼓励创新，加快新药创制，满足公众用药需求，国家局发布了《关于调整药物临床试验审评审批程序的公告》（2018年第50号,以下简称50号公告），实行临床试验默许制以及pre-IND沟通流制度。

自50号公告实施以来，符合要求的创新药I期临床试验申请均得到了快速审评。

对于I期临床试验申请，为了保障受试者的安全，药学审评通常重点关注与安全性相关的问题，例如杂质、稳定性、无菌制剂生产条件和除菌/灭菌方法、以及临床前动物安全性评价试验与后续人体临床试验所用样品的质量可比性等。

国家局发布的《新药I期临床试验申请技术指南》（2018年第16号）对相关药学研究内容和资料提交要求已经进行了阐述，但是审评中发现部分创新药I期临床试验申请仍然存在一些与上述安全性内容相关的药学问题。

为了更好地实施国家局50号公告，促进创新药的研究和开发，本技术要求对创新药I期临床试验申请药学共性问题进行总结，以供申请人参考。

一、关于样品试制共性问题：提供的样品试制信息非常有限，处方工艺信息（特别是涉及复杂原料药或者复杂制剂时）过于简单。

一般性要求：参照《新药I期临床试验申请技术指南》相关要求提供原料药和制剂的生产商、生产地址和处方工艺信息，汇总关键研究批次（包括用于安全性研究、稳定性研究、临床研究（如已制备）等批次）的试制信息、关键项目的批分析数据等。

对于复杂原料药（例如多肽、小分子核酸、聚合物产品、含多个手性中心、含发酵工艺或者天然来源等药物）、复杂制剂（例如微球/微乳/脂质体、胶束、透皮制剂、吸入制剂等）、复杂给药途径（例如制备成混悬液、乳液或者凝胶通过皮科、眼科和耳用等局部给药）以及复杂药械组合产品，应注意对重要的生产步骤、设备和工艺参数等进行较为详细的描述。

对于无菌制剂，应对无菌生产条件和除菌/灭菌方法等进行较为详细的描述，并且提供无菌保障措施。

鉴于国内目前临床试验申请为60天默许制，I期临床试验申请如果研究资料符合要求通常可快速开展临床试验，建议申报I期临床试验时（特别是涉及复杂原料药和制剂、复杂给药途径、药械组合产品时）在拟定的临床样品制备地点至少完成1批样品的制备，并且提供相关的试制信息、检验报告。

Administrative Regulation on the Communication for Drug R&D Activities andTechnical Review(Draft for Comment)Chapter I General ProvisionsArticle 1This regulation is formulated for the purpose of good performance of communication and standardization of the communication between the applicants and the Center for Drug Evaluation of NMPA (hereinafter referred to as CDE), by following the principles of the Pharmaceutical Administration Law of the People's Republic of China, and Measures for the Administration of Drug Registration.Article 2The communication, described in this regulation, is defined as the consultation and discussion applied by the applicants during the drug research and development process, through negotiation between the project management staff of CDE (hereinafter referred to as the “Project Manager”) and the drug registration specialist designated by the applicant, and approved by the review team of CDE, discussing the key technical issues that are not covered by the current drug R&D and review guidelines.Article 3The forms of communication include: face-to-facemeeting, video conference, teleconference and written correspondence. Applicants are encouraged to communicate with CDE through teleconference. The proposal, consultation and conduct of the communication, as well as the preparation, convening, recording and minutes of relevant meetings, shall comply with this regulation.Article 4The communication meetings stipulated in this regulation shall be applicable to the communication and consultation for the innovative drugs, modified new drugs, biosimilar drugs, Chinese herbal medicine compound preparation based on traditional classic prescription, drugs with the same name and prescription, complex generic drugs, and equivalency assessment drugs during their R&D process and registration applications.Article 5Communication is an interaction process dealing with the technical issues between the applicant and the review team, during which both parties may fully present their respective viewpoints with regard to such issues.Chapter II Types of Communication MeetingsArticle 6Communication Meetings are divided into Class I, Class II and Class III meetings, at which the communication takes place in respect to major issues at key stages.(I)Class I meeting is defined as the meeting held on thepurpose to address the major safety issues encountered during the clinical trials of drugs, and the major technical issues in the R&D process of the breakthrough therapeutic drugs, or held in other prescribed situations.(II)Class II meeting is defined as the meeting held at the key stages of drug R&D process, which mainly include the following situations:1.Pre-Clinical Trial Application meeting. To address majortechnical issues before the first submission of the clinical trial application, the following issues can be discussed, including but not limited to: whether the available research data supports the proposed clinical trial; whether the risk of clinical trial subjects is controllable. The communication meeting materials prepared by the applicant shall include complete information on the clinical trial protocols or drafts, existing pharmaceutical and non-clinical study data, and other research data. For the clinical trial applications of the first global applications of the drugs with new mechanism and new structure, the applicant shall initiate the communication with CDE, and the technical requirements on the registration shall be established clearly.2.End of Phase II clinical trial of drugs/Phase III pre-clinicaltrial meeting. To address major technical issues encounteredat the end of Phase II clinical trial and prior to the initiation of pivotal Phase III clinical trial, the following issues can be discussed, including but not limited to: whether the available research data can fully support the proposed Phase III clinical trial; make assessment on Phase III clinical trial protocol.3.Pre-meeting for drug marketing authorization. To explorewhether the available research data meets the technical requirements for the application for drug marketing authorization, the following issues can be discussed, including but not limited to: whether the available research data supports the technical requirements for the application for drug marketing authorization. The applicant for conditional approval and/or for priority review approval procedures shall communicate with the CDE before submitting the application for drug marketing authorization to NMPA.4.Risk assessment and control meeting. This meeting is tohave a discussion before NDA approval on the adequacy and controllability of the post-marketing risk control in order to assess and control the post-marketing risk.5.Other circumstances of Class II meetings as prescribed. (III)Class III meeting is defined as the meetings other than ClassI and Class II meetings.Article 7Applicants who have fallen into one of the following circumstances may propose the corresponding communication application based on the proposed studies or submissions in accordance with the provisions of the three classes of meetings mentioned above.(I)For clinical trial application of adding new indication, theapplicant shall carry out the research on the basis of available data in combination with the characteristics of the new indication, and make communication with CDE if necessary.(II)For the key technical issues found during the R&D process of drugs for urgent clinical needs or treatment of rare diseases, the applicant may make the communication application.(III)For the major R&D issues in the complex generic drugs and equivalency assessment or re-assessment drugs (e.g.selection of the reference preparation, evaluation criteria for bioequivalence, etc.), the applicant may make the communication application.(IV)For the protocol designed for the complicated important non-clinical studies (e.g. carcinogenicity studies), the applicant may make the communication application. (V)Where there is technical disputation in the review process after the applicant has received the inquiry consultation andsupplementary notification, the applicant may make the communication application if the applicant still has any difference regarding the comprehensive assessment results. (VI)Application for communications can be made in the R&D process of drugs on the frontier technology field.Chapter III Proposal and Discussion of CommunicationMeetingsArticle 8The convening of a communication meeting shall meet the following basic conditions:(I)The “Application Form for Communication Meeting”(Annex 1) and “Communication Meeting Materials”(Annex 2) submitted shall comply with the requirements of the regulation;(II)"Communication Meetings Materials” and the "Application Form for Communication Meetings" shall be submitted at the same time;(III)The professional background of personnel participating in the communication meeting shall be qualified for the discussion on professional issues.Article 9Where the above communication requirements are met, the applicant shall submit the Application Form for Communication Meeting and Communication MeetingsMaterials through the “window of applicant” of the website of CDE, specifying the type of communication at application. Article 10Within 2 days of receiving the “Application Form for Communication Meeting”, the Project Manager shall complete the preliminary review according to requirements above. Where the materials are found not complete or to have fallen into other cases of nonconformity, the application shall be ended. Those meeting the requirements shall be further submitted to relevant professional review team.Within 18 days after the application, the review team shall determine how to carry out the communication: communication meeting (face-to-face meeting, video conference, teleconference) or written feedback. If the review team finds that any data is incomplete or inconsistent, the application shall be terminated directly.Article 11Within 20 days after the application, the Project Manager will notify the applicant the conclusion confirmed by the review team.For the communication meeting application approved, the Project Manager will notify the meeting agenda to the applicant through the “window of applicant” within 5 days after the confirmation of meeting date, including the date, place, matters needing attention and materials to be further discussed at the meeting.Article 12Communication meeting application may not beapproved for the following circumstances:(I)Additional data shall be provided before satisfying thecommunication requirements for the issues to be discussed; (II)The professional background of attendees is not qualified for the discussion of the technical issues and not satisfactory to the need for communication;(III)Other circumstances that do not guarantee the effective convening of the meeting.If the communication meeting cannot be convened, the Project Manager shall provide the specific reasons through the “window of applicant”. After finishing relevant works, the applicant can make a new communication application.Article 13If the communication meeting is approved, in general, Class I meeting will be held within 30 days after the application, Class II meeting will be held within 60 days after the application, and Class III meeting, within 75 days after the application.If the communication meeting is confirmed not to be held, the feedback shall be completed within the above-mentioned time limit according to the meeting type, in principle.Chapter IV Preparation for Communication MeetingsArticle 14The applicant shall submit the electronic version ofCommunication Meeting Materials in accordance with the requirements of the “Communication Meeting Materials” through the "Window of Applicant".Article 15To ensure the quality and efficiency of communication meetings, the drug registration specialist shall make comprehensive discussion with Project Manager before the meeting, and confirm the date, time, place and agenda of the meeting.Chapter V Convening of Communication MeetingsArticle 16The communication meeting will be chaired by the CDE staff, and conducted according to the pre-determined meeting agenda. Discussion shall be made on proposed issues put forward before the meeting. In principle, it is not within the scope of communication to raise new meeting materials, generate divergent issues and to temporarily add new issues. In general, the communication meeting duration shall be within 45 minutes, but not exceed 60 minutes.Article 17The minutes of meeting shall be prepared in accordance with the "Template of Communication Meeting Minutes" (Annex 3). Where both parties have reached an agreement, viewpoints in common shall be specified. If the parties fail to reach an agreement, their viewpoints shall be statedrespectively. The applicant is encouraged to make minutes of meeting on the spot, for the purpose of which the applicant can make a draft of the minutes before the meeting on the basis of the preliminary feedback from CDE and make it clear after discussion. If the minutes cannot be made on the spot for special reasons, the applicant shall generally submit the draft of minutes within one week after the meeting is completed. Minutes of meeting shall be finalized within 30 days upon the completion of the meeting. The Project Manager shall upload the minutes within 2 days upon finalization, to the communication system which can be accessed by the applicant through the “Window of Applicant”. Meeting minutes shall be archived as an important document. Article 18If necessary, CDE will make audio or video recordings of whole procedure of the meeting, and archive them as working files for future reference. The applicant and other attendees are not allowed to make any audio, video or photo recordings without permission. Where the applicant’s trade secrets are involved, CDE shall keep such trade secrets confidential in accordance with applicable laws.Chapter VI Postponement or Cancellation ofCommunication MeetingsArticle 19The meeting will be postponed if any of the following circumstances occurs:(I)The communication conditions are met but additionalinformation shall be supplemented;(II)The review team considers that there are other important issues beyond the meeting topic that need further discussion; (III)There are too many meeting materials for the review team to review in a limited period;(IV)The important attendees cannot attend the meeting on time; (V)Other force majeure factors.In general, the applicant shall be notified of the decision to postpone a meeting, at least 5 days prior to the meeting. The postponed meeting will be discussed by the Project Manager and the drug registration specialist. In general, the delay time shall not exceed 2 months. It will be considered that the meeting cannot be held if the delay time is more than 2 months due to the applicant, in which case the applicant is required to submit a new communication application after supplementing additional materials.Article 20 A meeting will be cancelled if any of the following situations occurs:(I)The meeting materials are not submitted within thespecified date;(II)The submitted meeting materials do not meet the requirements of this regulation;(III)The applicant makes the proposal of canceling the meeting which is approved by CDE;(IV)The issue from the applicant has been resolved or has been given written correspondence.In general, the decision to cancel a meeting shall be informed to the applicant 5 days prior to the meeting. After cancellation of the meeting, the applicant may submit a separate communication application according to this regulation.Chapter VII Supplementary ProvisionsArticle 21For the verification or consultation of general technical issues, the applicant may communicate with the Project Manager through the general technical issue consultation platform in "Window of Applicant", telephone, fax, E-mail, or by other means. Consultations on general technical issues will not include the key technical issues in drug R&D and technical review processes.Article 22When making submission of the drug registration dossier, the applicant shall appoint 1 or 2 drug registrationspecialists, and provide the specific information of the drug registration specialist such as the name and telephone number. The drug registration specialist shall be responsible for drug registration. The applicant shall make communication with CDE through the drug registration specialist, and the Project Manager shall only contact the drug registration specialist designated by the applicant. If there is any change of the drug registration specialist, the applicant shall make updates through the “Window of Applicant” in a timely manner.Article 23During the review process, CDE may make a proposal on communication as required, which will be discussed by Project Manager with the drug registration specialist to determine the, time, agenda, and information requirements for the communication meeting.Article 24The meeting materials used for communication shall be included in the applied registration documents (which may be compiled into an individual volume) as the basis for review. Important meeting materials prior to the submission of a drug registration application, e.g. Communication Meetings Materials, Application Form for Communication Meeting and meeting minutes, should be submitted by incorporating into the dossiers. The meeting materials generated during the review should be included into the dossiers by CDE.Article 25CDE staff shall strictly follow this regulation, andmust not contact the applicant privately in any way other than those provided in this regulation. The special case shall be approved by CDE.Article 26This regulation shall come into force as of the date of promulgation.Annexes:1.Application Form for Communication Meetingmunication Meeting Materials3.Template of Communication Meeting MinutesAnnex 1Application Form for Communication MeetingI.Basic information of drug research and development1.Applicant2.Drug name3.Acceptance number (if available)4.Chemical name and structure (or prescription, for ChineseTraditional Medicine)5.Proposed indications (or major functions)6.Dosage form, administration route and regimen (medicationfrequency and treatment cycle)7.Drug R&D strategies, including drug R&D backgroundinformation, drug development plans, brief description of the R&D process, key events, and current development status. II.Specific contents of meeting application1.Meeting types: Class I, Class II, or Class III.2.Classification of meeting: such as Pre-Clinical trialapplication meeting, End of Phase II clinical trial/Phase III pre-clinical trial meeting, Pre-meeting for drug marketing authorization or risk evaluation and control meeting.3.Meeting forms: face-to-face meeting, video conference,teleconference or written correspondences.4.Meeting objective: brief description.5.Proposed meeting date and time: please provide 3 alternatives.6.Proposed meeting agenda: including estimated duration foreach topic to be discussed (in general, the discussion duration of all topics should be controlled within 60 minutes.)7.List of attendees of applicant: the list shall set forth the namesof attendees, including the positions, job contents and work units. If the applicant plans to invite experts and interpreters to attend the meeting, they shall also be involved in the list.8.List of proposed issues under discussion: it is recommendedthat the applicant shall make the list of issues by discipline, including but not limited to the issues of the pharmaceutical, pharmacology & toxicology, and clinical practice. Each issue should include a brief description of background, the purpose of proposed issues and the applicant’s opinions of issues. In general, the number of issues to be discussed at a meeting shall not exceed 10.Annex 2Communication Meeting Materials1.List of issues under discussion: a list of issues that applicanthas finalized. It is recommended that the applicant shall make the list of issues by discipline, including but not limited to the issues of the pharmaceutical, pharmacology & toxicology, and clinical practice. Each issue shall include a brief description of background and the purpose of issues proposed.2.Supporting data summary: summary of supporting data bydiscipline and the order of issues.In terms of the summary of supporting data, relevant studies, results and conclusions shall be explained by data. Taking end of Phase II clinical trial meeting as an example, the clinical professional summary shall include the following: (1) a brief summary of completed clinical trials, including data, results and conclusions. Important dose-effect relationship information shall also be included. In general, a complete clinical study report does not need to be provided; (2) a detailed introduction of the proposed Phase III clinical trial protocol to confirm the main characteristics of clinical trials, such as clinical trial subject population, the key inclusion and exclusion criteria, clinical trialdesign (e.g., randomization, blinding, control selection, justification of non-inferiority threshold if non-inferiority trial used), dose selection, primary and secondary efficacy endpoints, and primary analysis methods (including planned interim analysis, characteristics of adaptation studies, and major safety concerns).Annex 3Template of Communication Meeting MinutesMeeting types: Class I, Class II, or Class III.Classification of meeting: such as Pre-clinical trial application meeting, End of Phase II clinical trial/Phase III pre-clinical trial meeting, Pre-meeting for drug marketing authorization or risk evaluation and control meeting.Date and time of the meeting:Meeting place:Acceptance number (if available):Drug Name:Proposed indications (or major functions):Applicant:Chairman:Recorder:Attendees: a list of all attendees of the applicant and CDE.Text:1.Purpose of the meeting:2.Meeting background:3.Issues discussed at the meeting and results:(1)Issue 1: XXXXXXXXXDo both sides reach consensus?□ Yes.Common opinion: XXXXXXXXX □ No.Applicant's comments:CDE's comments:(2)Issue 2: XXXXXXXXX…。

关于调整药物临床试验审评审批程序的公告（2018年第50号）颁布时间:20180724为鼓励创新，加快新药创制，满足公众用药需求，落实申请人研发主体责任，依据中共中央办公厅、国务院办公厅《关于深化审评审批制度改革鼓励药品医疗器械创新的意见》（厅字〔2017〕42号），对药物临床试验审评审批的有关事项作出调整：在我国申报药物临床试验的，自申请受理并缴费之日起60日内，申请人未收到国家食品药品监督管理总局药品审评中心（以下简称药审中心）否定或质疑意见的，可按照提交的方案开展药物临床试验。

现就具体事宜公告如下：一、沟通交流会议的准备与申请（一）申请人在提出新药首次药物临床试验申请之前，应向药审中心提出沟通交流会议申请，并在确保受试者安全的基础上，确定临床试验申请资料的完整性、实施临床试验的可行性。

（二）申请人准备的沟通交流会议资料应包括临床试验方案或草案、对已有的药学和非临床研究数据及其他研究数据的完整总结资料。

申请人应自行评估现有的研究是否符合申报拟实施临床试验的基本条件，并明确拟与药审中心讨论的问题。

（三）申请人应按照《药物研发与技术审评沟通管理办法（试行）》（以下简称《沟通交流办法》）要求，提交沟通交流会议申请表（附件1）。

药审中心应及时通知申请人是否召开沟通交流会议，并与申请人商议会议时间。

申请人应按沟通交流相关要求按时提交完整的沟通交流会议资料（附件2）。

药审中心对沟通交流会议资料进行初步审评，在沟通交流会议召开至少2日前，通过“申请人之窗”将初步审评意见和对申请人所提出问题的解答意见告知申请人。

申请人在收到初步审评意见和解答意见后，应尽快反馈问题是否已经得到解决。

申请人认为问题已经解决不需要召开沟通交流会议的，应通过药审中心网站“申请人之窗”告知药审中心取消沟通交流会议申请；申请人认为申请沟通交流的问题仍未得到解决的，按原定计划继续组织会议召开。

二、沟通交流会议的召开（四）会议由药审中心工作人员主持，双方围绕药物临床试验方案就申请人提出的关键技术问题，以及已有资料和数据是否支持实施临床试验开展和受试者安全风险是否可控进行讨论，并为后续研究提出要求和建议。

附件药物研发与技术审评沟通交流管理办法（试行）第一章总则第一条为规范申请人与国家食品药品监督管理总局药品审评中心（以下简称药审中心）之间的沟通交流，根据《国务院关于改革药品医疗器械审评审批制度的意见》（国发〔2015〕44号）等有关规定，制定本办法。

第二条本办法所指的沟通交流，系指在药物研发过程中，经申请人提出，由药审中心项目管理人员（以下简称项目管理人员）与申请人指定的药品注册专员共同商议，并经药审中心技术审评项目组长同意，就现行药物研发与评价指南不能涵盖的关键技术等问题所进行的沟通交流。

第三条沟通交流的提出、商议、进行，以及相关会议的准备、召开、记录和纪要等均应遵守本办法。

第四条本办法规定的沟通交流会议优先适用于创新药物、采用先进制剂技术药物，以及临床急需药物研发的注册申请中的沟通交流。

第二章沟通交流会议类型第五条沟通交流会议分为Ⅰ类、Ⅱ类和Ⅲ类会议。

（一）Ⅰ类会议，系指为解决药物临床试验过程中遇到的重大安全性问题和突破性治疗药物研发过程中的重大技术问题而召开的会议。

（二）Ⅱ类会议，系指为创新药物在研发关键阶段而召开的会议，主要包括下列情形：1.I期临床试验申请前会议。

为解决首次递交临床试验申请前重大技术问题，对包括但不限于下述问题进行讨论：现有研究数据是否支持拟开展I期临床试验；临床试验受试者风险是否可控等。

对研究数据支持开展I期临床试验且受试者风险可控达成一致的，申请人在会后方可向国家食品药品监督管理总局递交临床试验申请。

2.Ⅱ期临床试验结束/Ⅲ期临床试验启动前会议。

为解决Ⅱ期临床试验结束后和关键的Ⅲ期临床试验开展之前的重大技术问题，对包括但不限于下述问题进行讨论：现有研究数据是否充分支持拟开展的Ⅲ期临床试验；对Ⅲ期临床试验计划和临床试验方案进行评估。

3.提交新药上市申请前会议。

为探讨现有研究数据是否满足新药上市审查所需资料要求，对包括但不限于下述问题进行讨论：现有研究数据是否充分支持新药上市申请审查所需资料要求。

目录一、背景 (1)二、适用范围和基本要求 (1)三、沟通交流中临床试验方案的提交与回复 (3)（一）临床试验申请前的沟通交流 (3)1.沟通交流的申请 (3)2.对沟通交流问题的审核与回复 (3)（二）确证性（或关键性）临床试验前的沟通交流 (4)1.沟通交流的申请 (4)2.对沟通交流问题的审核与回复 (5)（三）临床试验期间的其他沟通交流 (6)（四）申请附条件批准上市的沟通交流 (6)（五）会议纪要或书面回复意见的撰写 (7)四、临床试验申请中试验方案的提交与审评 (8)（一）临床试验方案的提交 (8)（二）对临床试验方案的审评 (8)五、临床试验方案变更 (9)六、临床试验登记与信息公示 (10)一、背景国家药品监督管理局于2018年7月发布了《关于调整药物临床试验审评审批程序的公告》（2018年第50号），对药物临床试验的审评审批做出了调整，在明确60日默示许可的同时，也对沟通交流、临床试验申请提出明确规定。

其中，沟通交流会议资料的准备以及临床试验申请时申报资料要求中都明确了对临床试验方案的提交与评价。

临床试验方案作为承载临床试验目的、设计、方法学、统计学考虑和组织实施等详细内容的文件，是国家药品监督管理局药品审评中心（以下简称药审中心）对临床试验申请开展审评和基于临床试验方案进行沟通交流的核心资料，临床试验方案设计关系到药物临床试验的质量，同时也是保障受试者安全和获得高质量数据的关键内容。

根据《中华人民共和国药品管理法》《中华人民共和国疫苗管理法》《药品注册管理办法》的相关规定，为提高申请人撰写临床试验方案的质量、规范针对临床试验方案的沟通交流和各类注册申请，提高临床试验方案的审评质量，加强对申请人的技术指导，保证审评工作依法依规、公开透明，特制定本工作规范。

二、适用范围和基本要求根据相关法律法规的规定，申请人可在药物研发的不同阶段，通过沟通交流申请、临床试验申请、补充申请等方式提交临床试验方案。

国家药品监督管理局关于调整药物临床试验审评审批程序的公告⽂号：国家药品监督管理局公告2018年第50号颁布⽇期：2018-07-24执⾏⽇期：2018-07-24时效性：现⾏有效效⼒级别：部门规章为⿎励创新，加快新药创制，满⾜公众⽤药需求，落实申请⼈研发主体责任，依据中共中央办公厅、国务院办公厅《关于深化审评审批制度改⾰⿎励药品医疗器械创新的意见》（厅字〔2017〕42号），对药物临床试验审评审批的有关事项作出调整：在我国申报药物临床试验的，⾃申请受理并缴费之⽇起60⽇内，申请⼈未收到国家⾷品药品监督管理总局药品审评中⼼（以下简称药审中⼼）否定或质疑意见的，可按照提交的⽅案开展药物临床试验。

现就具体事宜公告如下：⼀、沟通交流会议的准备与申请（⼀）申请⼈在提出新药⾸次药物临床试验申请之前，应向药审中⼼提出沟通交流会议申请，并在确保受试者安全的基础上，确定临床试验申请资料的完整性、实施临床试验的可⾏性。

（⼆）申请⼈准备的沟通交流会议资料应包括临床试验⽅案或草案、对已有的药学和⾮临床研究数据及其他研究数据的完整总结资料。

申请⼈应⾃⾏评估现有的研究是否符合申报拟实施临床试验的基本条件，并明确拟与药审中⼼讨论的问题。

（三）申请⼈应按照《药物研发与技术审评沟通管理办法（试⾏）》（以下简称《沟通交流办法》）要求，提交沟通交流会议申请表（附件1）。

药审中⼼应及时通知申请⼈是否召开沟通交流会议，并与申请⼈商议会议时间。

申请⼈应按沟通交流相关要求按时提交完整的沟通交流会议资料（附件2）。

药审中⼼对沟通交流会议资料进⾏初步审评，在沟通交流会议召开⾄少2⽇前，通过“申请⼈之窗”将初步审评意见和对申请⼈所提出问题的解答意见告知申请⼈。

申请⼈在收到初步审评意见和解答意见后，应尽快反馈问题是否已经得到解决。

申请⼈认为问题已经解决不需要召开沟通交流会议的，应通过药审中⼼⽹站“申请⼈之窗”告知药审中⼼取消沟通交流会议申请；申请⼈认为申请沟通交流的问题仍未得到解决的，按原定计划继续组织会议召开。