FDA仿制药一致性评价指导指南(中英文版).pdf

SoltorisManagement Consultants, Inc. 洛施德企业管理咨询（上海）有限公司 Guidance for Industry Controlled Correspondence Related to Generic Drug Development 行业指南：有关仿制药研发的书面咨询 This guidance represents the current thinking of the Food and Drug Administration (FDA, or the Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. 该指南代表了 FDA 对该主题目前的看法。它并不会赋予任何人任何权利，也不会约束 FDA 或公众，如果有替 代的方法能够满足法律法规的要求，可以使用替代的方法。如果想探讨替代的方法，请联系该指南首页中 FDA 负责执行该指南的工作人员。 I. INTRODUCTION 简介 This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence. FDA is issuing this guidance as part of its implementation of the Generic Drug User Fee Amendments of 2012 (Public Law 112-144, Title III), commonly referred to as GDUFA. 该指南描述了仿制药生产商以及相关行业向FDA 提交书面咨询，询问有关仿制药研发信息的过程，同时还描 述了FDA 针对这些书面咨询提供交流的过程。该指南作为2012《仿制药申报者付费法案》（简称GDUFA ）（Public Law 112-144, Title III ）实施的一部分。 FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. FDA 的指南文件（包括该指南）不会构成任何法律强制职责，而是代表了FDA 对该主题的目前想法，仅作为 参考意见，除非引用了特定的法规或法定要求。该指南中“should”一词表示的是建议执行的内容，而不是必 须执行的。 II. BACK