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1、Guidance for Industry and Review StaffTarget Product Profile A Strategic Development Process ToolDRAFT GUIDANCE行业与评审员指南目标产品概述战略研发过程的工具草 案 This guidance document is being distributed for comment purposes only.本指南文件的发布仅供征求意见之用。Comments and suggestions regarding this draft document should be submitted
2、within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified wi
3、th the docket number listed in the notice of availability that publishes in the Federal Register.有关本草案文件的意见和建议应在联邦注册公布本草案生效之日起60天内递交。将意见递交至食品药品监督管理局档案管理部（HFA-305），地址为：5630 Fishers Lane, rm. 1061, Rockville, MD 20852。所有意见应用联邦注册颁布的生效通知中列出的档案编号进行标识。For questions regarding this draft document contact Je
4、anne M. Delasko at 301-796-0900. 如对本草案文件有任何问题，请致电301-796-0900，Jeanne M. Delasko将为您解答疑问。U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)March 2007Procedural美国卫生和人类服务部食品药品管理局药品评估和研究中心（CDER） 2007年3月程序性的Guidance for Industry and Revie
5、w StaffTarget Product Profile A Strategic Development Process Tool行业与评审员指南目标产品概述战略研发过程的工具Additional copies are available from:可从下述地址获得副本：Office of Training and CommunicationsDivision of Drug Information, HFD-240Center for Drug Evaluation and ResearchFood and Drug Administration5600 Fishers LaneRockv
6、ille, MD 20857(Tel) 301-827-4573http:/www.fda.gov/cder/guidance/index.htm药品信息部的培训和通信办公室，HFD-240药品研究和评价中心食品和药品管理局5600 Fishers LaneRockville, MD 20857(电话) 301-827-4573http:/www.fda.gov/cder/guidance/index.htmU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evalua
7、tion and Research (CDER)March 2007Procedural美国卫生和人类服务部食品和药品管理局药品研究和评价中心（CDER） 2007年3月程序化文件TABLE OF CONTENTS目 录I. INTRODUCTION 引言II. BACKGROUND 背景III. DESCRIPTION AND BENEFITS OF A TPP TPP的介绍及其优点A. Purpose of a TPP TPP的目的B. Attributes of a TPP TPP的特点C. Advantages of a TPP TPP的优点D. What a TPP is Not T
8、PP不具备的属性E. Using a TPP as Part of a Briefing Document 使TPP成为摘要文件的组成部分IV. COMPLETING A TPP 完成一份TPPA. Labeling Concepts 标签内容B. Proposed Promotional Claims 需要改进的内容的建议V. LINKAGES WITH OTHER INITIATIVES 与其它主动努力的关系VI. CONCLUSION结论APPENDIX A: CASE STUDIES附录A：案例研究A. Advantages of Using a TPP During Developm
9、ent of an Antibacterial Drug使用TPP在研发抗菌药物时表现出来的优势B. Advantages of Using a TPP During Development of a New Therapy for Osteoporosis使用TPP在研发骨质疏松质的新疗法时表现出来的优势C. Disadvantages of Not Using a TPP for an EOP2 MeetingEOP2会审时未使用TPP所造成的不利之处D. Disadvantages of Not Using a TPP Early in Development在研发早期不使用TPP所造成
10、的不利之处APPENDIX B: SAMPLE SECTION OF A TPP附录B：TPP的样品部分APPENDIX C: TARGET PRODUCT PROFILE TEMPLATE 附录C：目标产品概述的模板Guidance for Industry and Review Staff 1 Target Product Profile A Strategic Development Process Tool行业与评审员指南1目标产品概述战略研发过程的工具This draft guidance, when finalized, will represent the Food and Dr
11、ug Administrations (FDAs) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you wan
12、t to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.本指南草案代表了截至完稿时FDA对本议题目前的想法。不授予任何人任何权利，也不对FDA或公众造成任何约束。如果有其它方法能够满足当前适用的条例和法规，也
13、可以采用。如果您想同FDA讨论其它替代方法，请与负责执行本指南的FDA管理人员联系。如果您不能确定应和哪位FDA管理人员联系，请按本指南标题页上的电话号码查询。I. INTRODUCTION引言The purpose of this guidance is to provide sponsors and the review staff in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) with information regarding target
14、product profiles (TPPs). A TPP is a format for a summary of a drug development program 2 described in terms of labeling concepts. A TPP can be prepared by a sponsor and then shared with the appropriate FDA review staff to facilitate communication regarding a particular drug development program. Subm
15、ission of a TPP is voluntary.本指南旨在向主办者和食品和药品监督管理局下属的药品研究和评价中心（CDER）的评审人员提供有关目标产品概况（TPP）的信息。TPP即标签概念项下所描述的药品研发项目2的摘要格式。可由主办者起草某一特定药品研发项目的TPP，然后与FDA的评审员共享，促进沟通与交流。TPP文件的递交是一种自愿行为。This guidance describes the purpose of a TPP, its advantages, and its optimal use. It also provides guidance on how to complete a TPP and relates case studies that demonstrate a TPPs usefulness.本指南阐述了TPP的目的、优点和最佳使用方法；同时也给出指导如何完成TPP及能够证明TPP有效性的相关案例研究。FDAs guidance documents, including this guidance, do not establish legally enforceable responsibilitie
