Steering Committee RHSC Update Michelle Limoli Nobumasa Nakashima CoChairs RHSC 24 February 2021 Regulatory Harmonization Steering Committee Mission facilitate regulatory cooperation among medical product regulatory authorities build human capacity in regulatory science among me ID: 1020465
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1. Report to LSIF: Regulatory Harmonization Steering Committee (RHSC)UpdateMichelle LimoliNobumasa NakashimaCo-Chairs, RHSC24 February 2021
2. Regulatory Harmonization Steering CommitteeMission: facilitate regulatory cooperation among medical product regulatory authorities, build human capacity in regulatory science among medical product regulatory staff, and promote political will for convergence among regulatory policymakers in APECEst 2009Scope: Pharmaceutical Products & Medical DevicesMembers: Regulators from APEC EconomiesIndustry coalitions:Research-based PharmaceuticalsMedical Devices Generic Pharmaceutical Biotechnological Products Advanced Therapies CoE Coalition of Training Partners
3. RHSC Guiding PrinciplesMandate: To promote a more strategic, effective and sustainable approach to regulatory convergenceRHSC doesn’t produce harmonized guidances - promotes use & implementation of existing international standards, guidelines and best practicesVoluntary basis for engagement: ensures participation of those economies interested and committed to activitiesLeverage work with other international harmonization initiatives to avoid duplication of work & most effective use of resources
4. Regulatory ConvergenceVoluntary process whereby regulatory requirements across economies become more aligned over time as a result of the adoption of internationally recognized technical guidances, standards and best practices It does not seek to establish new or change existing legal frameworks, laws, or regulations. It does not require regulators to be subject to any outside authority or prevent regulatory authorities from protecting and promoting public health. It does not have a specific endpoint; regulatory convergence is never “complete” or “achieved” as new products are developed, new standards are established, and new regulatory staff begin careers.Regulatory reliance: a regulatory authority in one jurisdiction may take into account and give significant weight to – i.e., totally or partially rely upon – evaluations performed by another regulatory authority or trusted institution in reaching its own decision. The relying authority remains responsible and accountable for decisions taken, even when it relies on the decisions and information of others.
5. Priority Work Areas (PWAs)Multi Regional Clinical Trials and Good Clinical Practices Inspections (Japan and Thailand)Pharmacovigilance (Korea)Biotherapeutic Products (Current PWA Management: US and BIO)Advanced Therapy Products (Singapore and US)Good Registration Management (Chinese Taipei and Japan)Global Supply Chain Integrity (US)Medical Devices (Japan, Korea and US)
6. Centers of Excellence (CoEs)The Vision A sustainable platform for promoting regulatory convergence, capacity and cooperation in areas of medical products Science and best practice focusThe Approach Partnership among training institutions/organizations, regulators and industry, to deliver and maintain educational programsCoE Host Institutions collaborate with PWA Champions, PWA Steering Committee and CoE CoalitionFollow defined principles in CoE Operating ModelEnsure quality & consistent training programs via PWA Roadmap, Core Curriculum, Training Objectives, Performance Indicators & periodic assessments
7. Current APEC Regulatory Training CoEs:Peking University (MRCT/GCP and Pharmacovigilance)Sichuan University (Medical Devices)PMDA (Pharmacovigilance, MRCT/GCP, Medical Devices)Kobe University (Biotherapeutic Products)KIDS (Pharmacovigilance)NIDS (Medical Devices)KoNECT (MRCT/GCP)Taylor’s University (Supply Chain)Duke-NUS Singapore (MRCT/GCP and Advanced Therapy Products)Thai FDA (GRM)TFDA (Medical Devices)RAPS in cooperation with TFDA (GRM)Northeastern University (Biotherapeutic Products and Advanced Therapy Products)University of Tennessee HSC (Supply Chain)USP (Supply Chain)The MRCT Center of Brigham and Women’s Hospital and Harvard (MRCT/GCP) USC (Medical Devices)
8. RHSC 2020 MeetingsBiannual Meetings held virtually in June & December (COVID-19 restrictions)Continued good progress2021 Meetings to be virtualDecember 2020 highlights
9. Dec 2020 Virtual Meeting OutcomesRHSC Website created and continually updated by RHSC SecretariatStandardize RHSC Activities: Endorsement of Revised CoE Operating Model, PWA Roadmap Template, Pilot CoE Application Form, CoE “Checklist” for applications, and new CoE Assessment Plan for periodic evaluationsRHSC Forum Proposal endorsed for discussion of topics not specifically included in PWA Core Curriculum, including the ability to apply for AHC fundingUpdates on 2020 activities & future plans of all PWAs
10. Current APEC Regulatory Training Pilot CoEs:Duke-NUS Singapore (Biotherapeutic Products and Medical Devices)Northeastern University (Medical Devices)USP (Advanced Therapy Products)Medical Device Authority, MOH Malaysia (Medical Devices)*Endorsed in PrincipleNEW: Endorsements at Dec 2020 MeetingAPEC Regulatory Training CoEs:Soonchunhyang University (Medical Devices)
11. 2021 RHSC PlansVirtual Meetings – most likely May & DecEncourage further standardization of activities Revise PWA Roadmaps to reflect current situation & operationsPromote PWA Steering Committees for cross-talkContinually update Core Curriculum Develop measurable KPIsPlan for assessments of current CoEs – 5yr MoUs expiring in 2022Continue our work in accordance with LSIF endorsed 2030 Vision and Strategic Framework
12. 2021 Planned CoE ProgramsPriority Work AreaCoE/PilotOrganizationLocationDatesAdvanced Therapy ProductsPilot CoEUSPOnline2, 4, 9, 10 March 2021Advanced Therapy ProductsCoENEUTBC2nd half of 2021Biotherapeutic ProductsCoENEUTBCTBCGlobal Supply Chain IntegrityCoETaylor’s University & USPOnline27 Jan 2021Good Registration ManagementCoETFDAOnline/In-person2nd half of 2021 (International)Good Registration ManagementCoETFDATBC2nd half of 2021 (Local)Medical DevicesCoEUSCOnlineApr 2021Medical DevicesCoESCUTBCTBCMedical DevicesCoEPMDATBCTBCMedical DevicesCoENIDSTBCOct 2021Medical DevicesCoETFDATBCQ3 2021Medical DevicesCoESCHOnlineTBCMedical DevicesPilot CoENEUTBC2nd half of 2021MRCT/GCPCoEPMDA (& NCC Japan)Online18-21 January 2021MRCT/GCPCoEPKUOnline & In-personQ2 2021MRCT/GCPCoEMRCT CenterOnlineTBCMRCT/GCPCoEMRCT CenterPeruTBC (In-country Training)MRCT/GCPCoEKoNECTOnlineTBCPharmacovigilanceCoEPMDAOnline1- 4 February 2021PharmacovigilanceCoEPKUTBCTBCPharmacovigilanceCoEKIDSTBCTBC
13. Thank you!