GoodANDASubmissionPractices
Guidance for Industry
行业指南:优良ANDA申报规范(草案)
This guidance document is being distributed for comment purposes on
Comments and suggestions regardingthis draft document should be submitted within 60 days ofpublication in the Federal Register ofthe notice announcingtheavailabilityofthe draftguidance. Submit electronic comments to https://www.regulations.gov.Submit writtencomments to the DocketsManagement Staff(HFA-305), Foodand Drug Administration, 5630FishersLane, Rm. 1061, Rockville, MD20852.All comments should be identified with thedocket number listed in the notice ofavailabilitythat publishes in the Federal Register.
For questions regardingthis draft document, contact (CDER)Lisa Bercuat240-402-6902.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
January 2018 Generics
Additionalcopiesareavailablefrom:
OfficeofCommunications,DivisionofDrugInformationCenterforDrugEvaluationandResearch
FoodandDrugAdministration
10001NewHampshireAve.,HillandaleBldg.,4th FloorSilverSpring,MD20993-0002
Phone:855-543-3784or301-796-3400;Fax:301-431-6353
Email:druginfo@fda.hhs.gov
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
下载地址::https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm591134.pdf
Good ANDA Submission Practices
行业指南:优良ANDA申报规范(草案)
This draftguidance, when finalized, willrepresentthecurrentthinkingofthe Food and DrugAdministration (FDA orAgency)on this topic.Itdoes not establish anyrights foranyperson and is notbindingon FDA orthe public. Youcan use an alternative approach ifitsatisfies the requirements oftheapplicablestatutesandregulations.To discussan alternative approach,contactthe FDA staffresponsibleforthis guidance as listed on thetitle page.
本指南草案在定稿时将代表FDA对此主题当前的态度。它并不赋予任何人以任何权力,也不对FDA和公众形成约束。只要替代方法满足适用的法律法规要求,你可以使用替代方法。如需对替代方法进行讨论,请联系列在标题页的本指南FDA负责员工。
This guidance is intended to assist applicants preparingto submit to FDAabbreviated newdrugapplications (ANDAs). This guidance highlightscommon, recurringdeficiencies that mayleadto adelayin the approvalof an ANDA. It also makes recommendations to applicants on howtoavoid these deficiencieswith the goal ofminimizingthenumberof reviewcycles necessaryforapproval.
本指南意在帮助申报人准备给FDA的ANDA申报。本指南主要关注了可能会导致ANDA批准延迟的常见重复缺陷,也为申报人给出建议要如何避免这些缺陷,以尽可能减少批准所需的审评轮次。
Ingeneral, FDA’sguidance documents do not establish legallyenforceableresponsibilities.Instead,guidances describe the Agency’s current thinkingon atopic and should be viewed on
一般来说,FDA的指南文件并不建立法定强制义务,相反,指南所述的只是当局目前对某个主题的想法,除引用具体法规或法律要求外,均仅应作为建议看待。SHOULD一词在官方指南中表示建议或推荐某事但并非强制。
[1] ThisguidancehasbeenpreparedbytheOfficeofGenericDrugsandtheOfficeofPharmaceuticalQualityintheCenterforDrugEvaluationandResearchattheFoodandDrugAdministration.本指南由FDA的CDER的OGD和OPQ办公室起草。