Regulatory Harmonization Steering Committee Update
Facilitate regulatory cooperation among medical product regulatory authorities, build human capacity in regulatory science, and promote political will for convergence among regulatory policymakers in APEC. RHSC promotes the use and implementation of existing international standards and best practices on a voluntary basis, ensuring participation of interested economies and leveraging work with other harmonization initiatives to avoid duplication and optimize resources.
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Report to LSIF: Regulatory Harmonization Steering Committee (RHSC) Update Michelle Limoli Nobumasa Nakashima Co-Chairs, RHSC 24 February 2021
Regulatory Harmonization Steering Committee Mission: 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 APEC Est 2009 Scope: Pharmaceutical Products & Medical Devices Members: Regulators from APEC Economies Industry coalitions: Research-based Pharmaceuticals Medical Devices Generic Pharmaceutical Biotechnological Products Advanced Therapies CoE Coalition of Training Partners
RHSC Guiding Principles Mandate: To promote a more strategic, effective and sustainable approach to regulatory convergence RHSC doesn t produce harmonized guidances - promotes use & implementation of existing international standards, guidelines and best practices Voluntary basis for engagement: ensures participation of those economies interested and committed to activities Leverage work with other international harmonization initiatives to avoid duplication of work & most effective use of resources
Regulatory Convergence Voluntary 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.
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)
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 focus The Approach Partnership among training institutions/organizations, regulators and industry, to deliver and maintain educational programs CoE Host Institutions collaborate with PWA Champions, PWA Steering Committee and CoE Coalition Follow defined principles in CoE Operating Model Ensure quality & consistent training programs via PWA Roadmap, Core Curriculum, Training Objectives, Performance Indicators & periodic assessments
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)
RHSC 2020 Meetings Biannual Meetings held virtually in June & December (COVID-19 restrictions) Continued good progress 2021 Meetings to be virtual December 2020 highlights
Dec 2020 Virtual Meeting Outcomes RHSC Website created and continually updated by RHSC Secretariat Standardize 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 evaluations RHSC Forum Proposal endorsed for discussion of topics not specifically included in PWA Core Curriculum, including the ability to apply for AHC funding Updates on 2020 activities & future plans of all PWAs
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 Principle NEW: Endorsements at Dec 2020 Meeting APEC Regulatory Training CoEs: Soonchunhyang University (Medical Devices)
2021 RHSC Plans Virtual Meetings most likely May & Dec Encourage further standardization of activities Revise PWA Roadmaps to reflect current situation & operations Promote PWA Steering Committees for cross-talk Continually update Core Curriculum Develop measurable KPIs Plan for assessments of current CoEs 5yr MoUs expiring in 2022 Continue our work in accordance with LSIF endorsed 2030 Vision and Strategic Framework
2021 Planned CoE Programs Priority Work Area Advanced Therapy Products Advanced Therapy Products Biotherapeutic Products Global Supply Chain Integrity CoE/Pilot Pilot CoE CoE CoE CoE Organization USP NEU NEU Taylor s University & USP TFDA TFDA USC SCU PMDA NIDS TFDA SCH NEU PMDA (& NCC Japan) PKU Location Online TBC TBC Online Dates 2, 4, 9, 10 March 2021 2nd half of 2021 TBC 27 Jan 2021 Online/In-person 2nd half of 2021 (International) TBC 2nd half of 2021 (Local) Online TBC TBC TBC TBC Online TBC Online 18-21 January 2021 Good Registration Management Good Registration Management Medical Devices Medical Devices Medical Devices Medical Devices Medical Devices Medical Devices Medical Devices MRCT/GCP CoE CoE CoE CoE CoE CoE CoE CoE Apr 2021 TBC TBC Oct 2021 Q3 2021 TBC 2nd half of 2021 Pilot CoE CoE MRCT/GCP CoE Online & In- person Online Peru Online Online TBC TBC Q2 2021 MRCT/GCP MRCT/GCP MRCT/GCP Pharmacovigilance Pharmacovigilance Pharmacovigilance CoE CoE CoE CoE CoE CoE MRCT Center MRCT Center KoNECT PMDA PKU KIDS TBC TBC (In-country Training) TBC 1- 4 February 2021 TBC TBC
