FDA指南:ANDA原料药和制剂稳定性试验问答(201405).doc
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1、 201405 FDA指南:ANDA:原料药和制剂稳定性试验问答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Final GUIDANCE最终稿指南U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)May 2014Ge
2、nericsGuidance 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
3、 New Hampshire Ave., Silver Spring, MD 20993Phone: 301-796-3400; Fax: 301-847-8714druginfofda.hhs.govU.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)May 2014Generics TABLE OF CONTENTS 目录I. INTRODUCTION介绍II. QUESTIONS AND ANSWERS提问
4、和回答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 IndustryANDAs: Stability Testing of Drug Substances and ProductsQuestions and AnswersANDA:原料药和制剂稳定性试验问答This guidance
5、 represents 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
6、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
7、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INTRODUCTION介绍This guidance provides answers to questions from the public comments we received on the draft guidance for industry on ANDAs: Stability Testing of Drug Substances and Products(stabil
8、ity guidance) that published on September 25, 2012. The final guidance for industry of the same title published on June 20, 2013.Comments received on the draft of this guidance published in the Federal Register of August 27, 2013 have also been incorporated. General issues; drug master files (DMFs);
9、 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)
10、are used interchangeably.本指南是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。本指南也吸收了2013年8月27日的草案意见。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
11、 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 word should in Agency guidances means that something is suggested or recommended, but no
12、t 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, Dru
13、g, 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 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。 实施日期2013年6月20日。-Q2: How will this guidan
14、ce affect the Presidents Emergency Plan for AIDS Relief (PEPFAR)and positron emission tomography (PET) ANDAs?本指南对缓解艾滋病总统紧急法案(PEPFAR)和正电子成像术(PET)ANDA有何影响?A2: For chemistry, manufacturing, and controls (CMC) information, PEPFAR ANDAs should follow the guidance for industry on Fixed Dose Combinations,
15、Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV对于化学、生产和控制(CMC)信息,PEPFAR ANDA应遵守指南中对已批准的治疗艾滋病的抗逆转录病毒产品的固定剂量配方、组合包装药品、单化学体的规定。For PET ANDAs, the Agency recommends a minimum of three batches at or near the upper end of the proposed r
16、adio-concentration. If different synthesizers (methods of synthesis) are used, three batches from each method of synthesis at or near the upper end of the proposed radio-concentration are recommended. Batches do not have to be made in the same facility. For the additional manufacturing facilities, a
17、pplicants should provide stability data on at least one batch from each facility, although bracketing approaches could be submitted for review. For additional information, the Agency has published a guidance for industry on FDA Oversight of PET Products, Questions and Answers.对于PET的ANDA,当局建议至少三个最高或接
18、近最高辐射强度批次。如果采用了不同的合成方式(合成方法),建议每个合成方式三个最高或接近最高辐射强度批次。每批不需要在同一个厂房合成。对于增加的生产场所,即使采用正交方法提交申报资料,申请人应提供每个场所至少一批供稳定性数据。对于增加的信息,当局已出版行业指南“FDA对PET产品的监管:问答”。-Q3(i): Can an ANDA be submitted with 6 months of accelerated stability and 6 months of long-term stability data?ANDA提交时可否只包括6个月的加速试验和6个月长期稳定性试验数据?A3(i)
19、: Yes. Stability data expectation at the time of ANDA submission is 6 months of accelerated and 6 months of long-term data. However, if 6 months accelerated data show significant change2 or failure of any attribute, 6 months of intermediate data are also recommended at the time of submission. 可以。要求提
20、交的是6个月加速稳定试验和6个月长期稳定性试验数据。但如果6个月回事数据显示有显著的变化或任何失败的迹象,建议提交时同时包括6个月的中间条件数据。Q3(ii): When do intermediate stability studies need to be initiated in the event of failure at accelerated condition?如果加速条件失败,什么时候开始中间条件稳定性试验?A3(ii): We recommend starting intermediate stability, accelerated, and long-term stud
21、ies at the same time so the data are available at the time of submission, if needed. 我们建议同时开展中间条件、加速和长期稳定性研究,这样在提交申报资料时就能获得所有需要的数据。Q3(iii): If one among the three batches in accelerated conditions show a significant change, what should be done?如果三批加速试验中有一批表现出显著性变更,应该怎么办?A3(iii): If accelerated data
22、show a significant change or failure of any attribute in one or more batches, an applicant should submit intermediate data for all three batches. In addition, the submission should contain a failure analysis (i.e., discussion concerning the observed failure(s). 如果加速数据有一批或更多批次表现出显著性变更或任何一个属性失败,申请人应该提
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