提升药品质量.pdf

1、1Advancing Pharmaceutical Quality Geoffrey Wu,Ph.D.DirectorOffice of Product Quality Assessment I Office of Pharmaceutical QualityCenter for Drug Evaluation and ResearchU.S.Food and Drug AdministrationGeneric Drug Forum 2025April 9,20252Pharmaceutical quality assures the availability,safety,and effi

2、cacy of every dose.Everyone deserves confidence in their next dose of medicine.www.fda.gov3OPQ Reorganization in 2024OPQs Quality AssessmentOffice of Product Quality Assessment I(OPQA I)Office of Program and Regulatory Operations(OPRO)Office of Product Quality Assessment III(OPQA III)Office of Produ

3、ct Quality Assessment II(OPQA II)OPQ DirectorDeputy Director for ScienceOffice of Pharmaceutical Manufacturing Assessment(OPMA)Office of Product Quality Assessment I(OPQA I)Office of Product Quality Assessment III(OPQA III)Office of Product Quality Assessment II(OPQA II)Office of Program and Regulat

4、ory Operations(OPRO)Integrated Quality Assessment(IQA)4Purpose for the OPQ TransformationEnable OPQ to carry out its 2023-2027 Strategic Plan and meet our vision and mission Increase our ability to respond to changes in an evolving workload,increasing complexity of pharmaceutical supply chains,and p

5、ublic health emergenciesCreate a more agile,connected,and influential organizationOPQ Reorganization in 20245OPQs Lifecycle Approach:To efficiently and effectively manage and conduct quality assessment for small or large molecules through the entire process from IND to NDA or BLA,Biosimilars and AND

6、As,and all post-approval changes.Provides holistic perspective to enhance decision-making abilityLeverages knowledge across user fee programs and applicationsPromotes agility within assessment officesBroadens capabilities improving our ability to balance workloadOPQ Assessment Future State VisionOPQ