201308 FDA指南：ANDA：原料药和制剂稳定性试验问答（中英文）Guidance for Industry行业指南ANDAs: Stability Testing of Drug Substances and ProductsQuestions and AnswersANDA：原料药和制剂稳定性试验问答DRAFT GUIDANCE指南草案This guidance document is being distributed for comment purposes only.本指南文件发布仅供讨论。Comments and suggestions regarding this draft document should be submitted within 60 days of publication in theFederal Registerof the notice announcing the availability of the draft guidance. Submit electronic comments tohttp:/www.regulations.gov. Submit written 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 with the docket number listed in the notice of availability that publishes in theFederal Register.For questions regarding this draft document contact (CDER) Radhika Rajagopalan 240-276-8546.U.S.Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)August 2013GenericsGuidance for IndustryANDAs: Stability Testing of Drug Substances and ProductsQuestions and AnswersANDA：原料药和制剂稳定性试验问答Additional copies are available from:Office of CommunicationsDivision of Drug Information, WO51, Room 2201Center for Drug Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave., Silver Spring, MD 20993Phone: 301-796-3400; Fax: 301-847-8714druginfofda.hhs.govhttp:/www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmU.S.Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)August 2013GenericsContains Nonbinding RecommendationsDraft Not for ImplementationTABLE OF CONTENTSI. INTRODUCTION介绍II. QUESTIONS AND ANSWERS问与答A. General一般问题B. Drug Master File药物主文件.C. Drug Product Manufacturing and Packaging药品生产和包装D. Amendments to Pending ANDA Application未批准ANDA申请的增补E. Stability Studies稳定性试验.Guidance for Industry1ANDAs: Stability Testing of Drug Substances and ProductsQuestions and AnswersANDA：原料药和制剂稳定性试验问答This draft guidance, when finalized, will represent the Food and Drug Administrations (FDAs) current thinking on this topic.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 want 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，如果最终定稿，代表的是FDA目前对这一专题的态度。它并未建立或赋予任何个人任何权利，并不与FDA或公众有任何绑定。你可以使用任何一种替代方法，只要所用的方法满足成文的法规要求。如果你想要讨论一个替代方法，请与FDA负责实施本指南的相关人员联系。如果你无法识别要联系的人，可以拨打本指南首页所列的相应的电话号。I. INTRODUCTION介绍This draft guidance provides answers to questions from the public comments we received on the draft guidance for industry onANDAs: Stability Testing of Drug Substances and Products(stability guidance) that published on September 25, 2012. The final guidance for industry of the same title published on June 20, 2013. General issues; drug master files (DMFs); drug product manufacturing and packaging; and stability studies are discussed in this guidance and are intended to clarify the stability testing data recommendations for abbreviated new drug applications (ANDAs). In this document, the terms drug substance and active pharmaceutical ingredient (API) are used interchangeably.本指南草案是2012年9月25日公布的行业指南草案（ANDA：原料药和制剂稳定性试验（稳定性指南）起草中收到的公众问题的答复汇总。该指南终稿在2013年6月20日出版。在本指南中，讨论了一般问题、DMF问题、药品生产和包装和稳定性研究，意在澄清对ANDA稳定性试验数据的一些意见。在本文件中，“药用物质”和“活性药用物质成份”交互使用。FDAs guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the wordshouldin Agency guidances means that something is suggested or recommended, but not required.FDA的指南文件，包括本指南，并未建立法定的强制责任。指南中只是描述了官方对一个议题的当前的考虑，除非引用了特定的法规或法定要求，则应只当作建议看待。在官方指南中，“应该（should）”一词表示这是建议或推荐，而非必须。A. General一般Q1: What is the scope of and implementation date for the stability guidance?稳定性指南的范围和实施日期？A1: The stability guidance covers all new ANDAs under the Federal Food, Drug, and Cosmetic Act, section 505 (j), and DMFs (Type II for drug substances that support the ANDAs). It does not apply to postapproval changes. The finalguidance availability will be announced in the Federal Register. The implementation date is June 20, 2014.稳定性指南适用于所有联邦内食品、药品和化妆品法规第505（j）下提交的新ANDA申请，和DMF申请（支持ANDA的二类药用物质）。不适用于上市后变更。最终指南将在联邦注册上公布。实施日期2013年6月20日。Q2: How will this guidance affect the Presidents Emergency Plan for AIDS Relief (PEPFAR)and positron emission tomogra