中英对照最新FDA发布的仿制药一致性最终指导原则.doc

The US Food and Drug Administrations (FDA) final guidance on controlled correspondence between the agency and the generic drug industry released Monday includes some changes that address industry questions and comments.FDA发布：仿制药生产商书面咨询最终指南，解决企业关心的问题BackgroundInitially released in August 2014, the draft guidance was the fourth guidance document under the 2012 Generic Drug User Fee Act, and was intended to address formal questions posed to FDA prior to the generic drug review process and to clarify questions capable of affecting a products review.背景： 该指南草案发布于2014年8月，是2012年《仿制药申报者付费法案》(Generic Drug User Fee Act，GDUFA)下的第四份指导文件，旨在解答仿制药评审前企业向FDA提出的正式问题，对会影响药品评审的问题做澄清。This guidance provides additional detail and recommendations for industry on:what inquiries FDA considers to be controlled correspondence for the purposes of meeting its GDUFA commitmentwhat information requestors can include in a controlled correspondencewhat information FDA will provide in its communications to requestors that have submitted controlled correspondence 该指导原则为企业提供了附加明细和建议: 什么样的咨询FDA认为是符合其GDUFA承诺的书面咨询什么样的信息可以包含在书面咨询中FDA在与递交书面咨询人交流时会提供什么样的信息The agencys definition of controlled correspondence encompasses a range of issues that can impact generic manufacturers and related industry (e.g., contract research organizations conducting bioanalytical or bioequivalence (BE) clinical trials, active pharmaceutical ingredient manufacturers, and excipient manufacturers).FDA对“controlled correspondence”,即本文中的“书面咨询”的定义涵括了一系列可影响仿制药生产商和相关产业的问题(例如进行生物分析或生物等效性(BE)临床试验的CRO，API生产商，还有辅料生产商)Minor Changes to DraftRevisions to the draft guidance include explanatory information that will assist generic manufacturers as they submit controlled correspondence to FDA. The final guidance also added a description of how to submit information to FDA’s Inactive Ingredient Database, and a description of enhanced communication to requestors regarding the status of their controlled correspondence. 草案细小改动：指南草案的修订包含了对解释