ICH 致力于制定统一的 ICH Q6(R1) 并推动全球质量标准制定的现代化.pdf

1、1LLwww.fda.govICH Efforts towards Developing a Unified ICH Q6(R1)and Modernizing Global Standards for Specifications Setting Ingrid Markovic,Ph.D.Senior Science Advisor for CMCFDA/CBERRegulatory Chair for ICH Q6 EWG and CBER ICH Quality Lead2024 CMC Strategy Forum JapanTokyo Marriott Hotel,JapanDece

2、mber 9-10,2024International Council for Harmonisation of Technical Requirementsfor Pharmaceuticals for Human Use3What are Specifications?Quality AttributeAnalytical ProcedureAcceptance RangeIdentityPurityPotencyMass SpecHPLCBioassay0.1%to 0.5%m/z ratio98%90-110%1.2.3.Specifications4OutlineBackground

3、 DriversTimelinesWays or working Early alignment Next steps 5Quality Discussion Group(QDG)EvolutionPage 5“Develop a harmonized pharmaceutical quality system applicable across the lifecycle of the product emphasizing an integrated approach to quality risk management and science”2003 ICH Quality Visio

4、n2014 IQDG 5 year PlanNovember 20182005-14 ICH Quality Guidelines ICH M7 mutagenic impurities2019-2021Review existing ICH guidance and recommend updatesIs the guideline outdated due to new technologies/techniques?The guideline is not up to date with current scientific understanding and principles?Wi

5、ll an update address issues/alignment from other ICH guidance?Will an update to the guideline address patient needs and accelerated access?Will changes drive alignment e.g.replace regional-specific guidance,support implementation in new regions?Stability(ICHQ1 series and Q5C)Specifications(ICHQ6A an

6、d 6B)7Specifications(ICHQ6A and Q6B)From:Two distinct guidances separating small and large molecules Specification controls are the key to product quality Based on batch experience Specifications must be fixed in development Aligned with long development and approval pathways To:Holistic principles