ICMRA 努力实现监管趋同和依赖：关于协作评估和混合检查试点的进展报告.pdf

1、ICMRA efforts to achieve Regulatory Convergence and Reliance A Progress Report on the Collaborative Assessment and Hybrid Inspection PilotsStelios Tsinontides,Ph.D.,FAIChEDirectorOffice of Pharmaceutical Manufacturing AssessmentOPQ/CDER/FDA09 December 2024OverviewOverview Problem Statement Backgroun

2、d of ICMRA Pilots Outcomes ICMRA Collaborative Assessment Pilot Outcomes ICMRA Collaborative Hybrid Inspection Pilot AcknowledgementCurrent LandscapeMarketing Authorization HolderorDrug ApplicantsPACMPPACMPPACMPPACMPPACMPMultiple submissionsMultiple assessmentsMultiple outcomesIndividual regulatory

3、authoritiesComplexity,cost,and delay in implementing changes and managing quality 125,000 PAC Data Points Demonstrate PAC Global Regulatory Complexity is a Huge Problem125,000 PAC data points collected from 16 of the top 25 pharma companies over a period of 3 years(2019-2021)It usually takes 3-5 yea

4、rs for full global approval of each PACThe long approval timelines increases supply chain complexity and risk of drug shortageX-Axis:Individual countries 1-156Y-Axis:Percentage of all PACs that took more than 6 months for approval per countryWHO recommendationLess than 10%of all(156)countries had at

5、 least 90%of all PACs taking no more than 6 months(WHO guideline)for approvalVinther,Ramnarine,Gastineau,OBrien,Brehm,Fryrear.Therapeutic Innovation&Regulatory Science https:/doi.org/10.1007/s43441-024-00614-9 ICMRA PilotsICMRA Pilots In July 2021,the International Coalition of Medicines Regulatory

6、Authorities(ICMRA)held a workshop on the learnings from the pandemic,where regulators and manufacturers faced an unprecedented challenge to rapidly increase manufacturing capacity for production of COVID-19 therapeutics and vaccines to meet global demand.Following the workshop,ICMRA launched two reg