应对药品生产挑战：常见工艺缺陷及上市前检查观察-Idzior.pdf

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1、Navigating Challenges in Drug Manufacturing:Common Process Deficiencies and Pre-Approval Inspection ObservationsAndrew IdziorChemistOffice of Pharmaceutical Manufacturing AssessmentOPQ|CDER|US FDAGeneric Drugs Forum(GDF)2025 April 10,2025fda.gov/cdersbiafda.gov/cdersbia2Learning Objectives Describe

2、the common process deficiencies associated with major withhold recommendations for generic drug applications Describe the common pre-approval inspection deficiencies associated with major withhold recommendations for generic drug applicationsfda.gov/cdersbiafda.gov/cdersbia3USA Marketed Generic Drug

3、s Generics and biosimilars:90 percent of all U.S.prescriptions but less than 18 percent of spending(1)2019 GAO-19-565 Report:12%of generic applications approved in the first review cycle from FY15 to FY17 FDA posted 88,119,91,product-specific guidance in years 2021,2022,and 2023 respectively(2)18%of

4、 generic applications approved in the first review cycle from FY22 to FY24(3)fda.gov/cdersbiafda.gov/cdersbia4CRL Deficiencies Deficiencies Communicated in CRL Deficiencies Classified as Major or Minor Major Amendment:6 or 8 or 10 months depending on various factors Minor Amendment:3 months(4)fda.go

5、v/cdersbiafda.gov/cdersbia5Challenge Question#1The review timeline for amendments in response to major deficiencies is:A.180 daysB.9 months or 18 monthsC.6 or 8 or 10 months D.3 monthsfda.gov/cdersbiafda.gov/cdersbia6Major CRL DeficienciesCategories are listed in FDA,“ANDA Submissions-Amendments to

6、Abbreviated New Drug Applications Under GDUFA-Guidance for Industry.”September 2024.Process:Guidance lists 10 major deficiency categoriesFacilities:“One or more facilities were found inadequate”“The facility was not clearly identified in Form FDA 356h”(4)fda.gov/cdersbiafda.gov/cdersbia7Collection a