中美仿制藥研發(fā)申報(bào)流程-文庫(kù)吧資料
2025-03-12 15:06本頁(yè)面
【正文】 trength/Formulation ? Antara (micronized fenofibrate caps) (2023) (130 mg is BE to Tricor 200 mg) ?New Formulation/Inactive Ingredient ? Avita (tretinoin gel) (new emollient) (1998) ? Abraxane (cremaphorfree paclitaxel) (2023) ? OxyADF (oxycodone formulated to reduce drug abuse) (in development) 505(b)(2)新藥的例子 ?New Active Ingredient ? Pexeva (paroxetine mesylate) (new salt) (2023) ?New Route of Administration ? Emezine (prochlorperazine) (new buccal/transmucosal delivery) (NDA pending) ? Oral amphotericinB (preclinical) ?Rx?OTC Switch ? Alavert (loratadine) (2023) 505(b)(2)新藥的例子 ?“ Generic Biologics” ? Omnitrope (rHGH) (2023) ? Glucagen (glucagon rebinant) (1998) ? Hyaluronidase (various approvals 202305) ? Fortical (calcitonin salmon rebinant) (2023) * Examples based on publicly available information FDA NDA 審評(píng)過(guò)程 FDA 可以使用已有數(shù)據(jù)用于審評(píng) NDA嗎？ ? HatchWaxman之前 ,國(guó)會(huì)限制 FDA在審評(píng) NDA X時(shí)應(yīng)用 NDA Y的數(shù)據(jù)： “No data in an NDA can be utilized to support another NDA without express permission of the original NDA holder.”[FDA “Finkel Memorandum” (1978, 1981)] ? HatchWaxman 解除只適合 ANDAs： ANDA process allows “generic producer of the fully tested drug to rely on the safety and efficacy data of a prior applicant . . . .” ? 505(b)(2) does not authorize such data reliance ? Merely sets conditions for certain NDAs ? Requires “full reports of investigations” establishing safety and effectiveness [21 USC 167。 355(b)(1)(A), (d)(1)] 美國(guó)仿制藥 A generic drug product is one that is parable to an innovator drug product ( also known as the reference listed drug (RLD) product as identified in the FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations) in dosage form, strength, route of administration, quality, performance characteristics and intended use. Generic drug applications are termed “abbreviated” in that they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. These parameters were established upon the approval of the innovator drug product, which is the first version of the drug product approved by the FDA. FDA審評(píng)仿制藥程序 二、美國(guó)仿制藥的申報(bào)、審評(píng)和研發(fā)對(duì)策 ?由 FDA的 OGD審評(píng) ?審評(píng)方式采用 QbR ?申報(bào)資料采用 CTD ?資料內(nèi)容也針對(duì)問(wèn)題 C o m p a r i s o n o f R e c e i p t s a n d A p p r o v a l s o f A N D A A p p l i c a t i o n s273261335346326335449563766213230306249266294310373413467307361 36401002003004005006007008009001995 1996 1997 1998 1999 2023 2023 2023 2023 2023 2023F i s c a l Y e a rNumber of SubmissionsR e c e i pt s A pp r o v als ( F ull T e nt at i v e )O ffi c e of G e n e r i c D r u gsM E D I A N A p p r o v a l T i m e s A N D A O R I G I N A L S2 8 . 22 4 . 71 9 . 61 8 . 71 7 . 31 8 . 91 8 . 4 1 8 . 31 7 . 31 6 . 31 6 . 30510152025301995 1996 1997 1998 1999 2023 2023 2023 2023 2023 2023F i s c a l Y e a rMonthsO ffi c e of G e n e r i c D r u gsP e n d i n g O r i g i n a l A p p l i c a t i o n s41742742237439556461578001002003004005006007008009001998 1999 2023 2023 2023 2023 2023 2023a t F i sc a l Y e a r e n dSubmissions in QueueO ffi c e of G e n e r i c D r u gsC o n t r o l l e d C o r r e s p o n d e n c e D o c u m e n t s R e c e i v e d45751163168511161502952020040060080010001200140016001999 2023 2023 2023 2023 2023 2023F I S C A L Y e arSubmissions of CorrespondenceOffice of Generic Drugs 如何保證審評(píng)質(zhì)量和效率？ ?Structured Product Labeling (SPL) ? Makes labeling available on Inter via National Library of Medicine (NLM) ?Review Efficiencies ? Early DMF review ? Cluster reviews – product specialists ? Supplement triaging at team leader level ? DBE Truncated Review ?Question based Review (Qb
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