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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for Industry 行业指南 ANDAs: Stability Testing of Drug Substances and Products Questions and Answers ANDA：原料药和制剂稳定性试验问答 DRAFT GUIDANCE 指南草案 This guidance document is being distributed for comment purposes only.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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to http://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 the Federal Register. For questions regarding this draft document contact (CDER) Radhika Rajagopalan 240-276-8546. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2013 Generics Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products Questions and Answers ANDA：原料药和制剂稳定性试验问答 Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 druginfo@fda.hhs.gov http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) August 2013 Generics Contains Nonbinding Recommendations Draft — Not for Implementation TABLE OF CONTENTS I. INTRODUCTION 介绍 II.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for Industry[1] ANDAs: Stability Testing of Drug Substances and Products Questions and Answers ANDA：原料药和制剂稳定性试验问答 This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic.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 on ANDAs: 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。 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 wordshould in 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 final guidance 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 President’s 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, Co-Packaged Drug Products, and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment of HIV[1].
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 radio-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, applicants 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。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): 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 change[2] or failure of any attribute, 6 months of intermediate data are also recommended at the time of submission.
可以。要求提交的是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变化或任何属性失败，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 studies 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): In the event accelerated data show significant change or failure of any attribute in one or more batches, intermediate data is recommended for all three batches.
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，则建议提交所有3批的中间条件的数据。 Q4: Can stability bracketing and/or matrixing be used to determine the configurations to be placed on stability for an original ANDA without prior approval from the Office of Generic Drugs (OGD)?
如果没有获得官方通用药（OGD）预批准，稳定性试验是否可以采用分类试验和/或正交试验来选择ANDA初始提交中的参数？ A4: Yes. You should follow the International Conference on Harmonisation (ICH) guidance for industry on Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products and its example tables.
可以。你可以根据ICH行业指南Q1D“新原料药和新制剂稳定性试验分类和正交设计”及其样表的要求进行设计。 Q5(i): If an application that qualifies for the Generic Drug User Fee Act (GDUFA) 10-month review is filed with 6 months of accelerated and 6 months of long-term data, and there are no blocking patents or exclusivities, will 24 months of expiration dating be granted?
如果申报符合仿制药付费法案（GDUFA）10个月审核要求，提交时包括了6个月的加速和长期稳定性试验数据，并且没有相关专利阻碍，也没有行政保护，那么会被批准24个月的有效期吗？ | 
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发表于 2013-12-4 13:17:10
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