GDUFA III 对 DMF 评估的影响-Perera.pdf

1、GDUFA III Impact on DMF AssessmentJayani Perera,Ph.D.Senior Chemist,Division of Product Quality Assessment XIX,Office of Product Quality Assessment IIIOffice of Pharmaceutical Quality,CDER|US FDASBIA Generic Drug Forum April 9-10,2025www.fda.gov2Overview High-level implementation processes Data Key

2、points Key take aways for Prior Assessment processwww.fda.gov3Assessment of DMF Solicited Off-cycle Amendments Under GDUFA III,FDA will assess solicited DMF amendments related to original ANDAs and PASs upon receipt even if the original ANDA or PAS in which the DMF is referenced is not currently und

3、er assessment Priority will be given to the amendments related to ANDAs for which acceptability of the DMF assessment may result in an approvalwww.fda.gov4Implementation Process High-Level OPQ triages the request to check priorityImportant:Notification of response to DMFOGD mailboxMAPP 5015.14:Prior

4、itization of Solicited DMF Amendments Associated With ANDAs or PASs not Concurrently Under Assessment.https:/www.fda.gov/media/178300/download Off-cycle solicited amendment received Priority High/LowOff-cycle assessment performed based on the availability of resourcesAny deficiencies are communicate

5、d via IRDMF assessment team conducts the review to meet set DTDSet the DTD to 120 daysEndHighLowwww.fda.gov5Impact on DMF Assessment Have an opportunity to conduct earlier assessment and leverage“off-cycle”time to get the DMF to an adequate status more quickly This should improve the number of appro

6、vals and reduce total number of cycles and time to approval We estimate between 70 to 100 solicited off-cycle amendments will be prioritized and reviewed annually under this enhancementwww.fda.gov6Solicited Off-cycle Process DataFY 2023FY2024FY2025(10/01/2024 to 02/26/2025)Total#of solicited amendme