2016年FDA在GDUFA下PAS申报指南

julia朱玉姣

10月新发布的指南

Guidance for Industry[1]

ANDA Submissions – Prior Approval Supplements Under GDUFA

行业指南

ANDA申报---GDUFA要求下预批准增补

This guidance represents  the current thinking of the Food and Drug Administration (FDA, or 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 office  responsible for this  guidance as listed on the title  page.    本指南代表了FDA对本主题当前的想法。它并不赋予任何人任何权力，亦不对FDA和公众具有约束力。如果满足适当的法定要求或法规要求，可以使用替代方式。如需讨论替代方法，请联系标题页上所列本指南FDA负责办公室。

I.           INTRODUCTION 概述

This guidance isintended to assist applicants preparing to submitto FDA prior approval supplements(PASs) and amendments to PASs for abbreviated new drug applications (ANDAs)under section 505(j) of theFederal Food, Drug, and CosmeticAct (FD&C Act)(21 U.S.C.355(j)).  The guidance explains how the Generic Drug User Fee Amendments of 2012 (GDUFA) relatesto PAS submissions.  The guidance also describes the performance metric goals outlined in the GDUFA Commitment Letter that FDA has agreed to meet[2],and clarifies how FDA will handlea PAS and amendments to a PAS foran ANDA subject to the GDUFA performance metric goals.

本指南意在协助申报者根据FDCA (21 U.S.C.355(j))第505（j）部分起草向FDA提交的ANDA的预批准增补（PAS），以及对PAS的补充。本指南解释了2012年修正的GDUFA费用与PAS申报之间的相关性。本指南还描述了FDA要达成的GDUFA承诺函中列出的绩效指标目标，澄清了FDA将如何处理GDUFA绩效指标目标中ANDA的PAS和对PAS的补充。

Specifically, this guidancedescribes how the GDUFA performance metric goalsapply to:

尤其是本指南描述了GDUFA绩效指标目标如何适用于：

·        A PAS subjectto the refuse-to-receive (RTR)standards

·        适用拒收（RTR）标准的PAS

·        A PAS thatrequires an inspection[3]

·        需要实施检查的PAS

·        A PAS forwhich an inspection is not required

·        不需要检查的PAS

·        An amendment to a PAS

·        对PAS的补充

·        Other PAS-related matters

·        其它PAS相关问题

In general, FDA’s guidancedocuments do not establish legally enforceable responsibilities. Instead, guidancesdescribe the Agency’s currentthinking on a topic and should be viewed only asrecommendations, unless specificregulatory or statutoryrequirements are cited.The use of the word shouldin Agency guidances means that somethingis suggested orrecommended, but not required.

一般来说，FDA的指南文件并不具备法定强制权力。相反，指南描述的是当局目前对某个主题的想法，应被视为仅仅是建议，其中引用具体法规或法定要求者除外。当局指南中SHOULD一词表示建议或推荐某件事，但并不是强制要求。

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[1] This guidancehas been preparedby the Officeof Generic Drugs in the Center for Drug Evaluation and Research (CDER)in cooperation with the Center for Biologics Evaluation and Research(CBER) at the Food and Drug Administration. 本指南由CDER与CBER合作起草。

[2] The performance metric goalswere proposed jointly by FDA and representatives of the generic drug industry. See GDUFA ProgramPerformance Goals and Procedures for fiscal years 2015 through2017 (Commitment Letter), available    at   http://www.fda.gov/downloads/ForIndustry/UserFees/GenericDrugUserFees/UCM282505.pdf.

绩效量度目标是由FDA和仿制药行业的代表联合提议的。参见2015-2017年GDUFA计划绩效目标和程序（承诺函）。

[3] Section 704 of the FD&CAct (21 U.S.C. 374) authorizes FDA to conductinspections.

FDCA的第704部分授权FDA实施检查。

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