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APEC

Asia-Pacific Economic Cooperation (APEC) Harmonization Center

Introduction

  • APEC began as a Ministerial-level dialogue group with 12 members in 1989 and it has a total of 21 member economies at present.
  • It consists of a Leaders' Meeting, Ministerial Meeting, Senior Officials' Meeting, 4 committees, 13 working groups, 8 sub-committees, one ad hoc group under Senior Officials' Meeting and 4 industry dialogues.
  • The goal of APEC is to realize an open economic community by ensuring free trade and investment and promoting economic and technical cooperation in the Asia-Pacific region, to resolve economic imbalances among members, to improve economic and social welfare, and to support sustainable and balanced economic growth and prosperity of member countries.

Scope of Activities

  • Participation in Regulatory Harmonization Steering Committee (RHSC) and operation of APEC Harmonization Center (AHC) under Life Sciences Innovation Forum (LSIF), Committee on Trade & Investment (CTI)
  • Establishment of AHC under the National Institute of Food and Drug Safety Evaluation in June 2009 as an international training center aimed at harmonization of regulatory requirements and procedures for medicinal products in the Asia-Pacific region
  • AHC focuses on ① training in regulatory harmonization in the APEC region, ② research on regulatory harmonization related policies, ③ sharing of information on regulatory harmonization in the APEC region through its web site, and ④ establishment of the network among member economies and international organizations related to medicinal products.
  • Champion economy of pharmacovigilance and biotherapeutics among priority work areas (PWAs) set by the RHSC

Key activities

  • Hosting a total of 41 workshops for PWAs (i.e. Pharmacovigilance, Biotherapeutics, Medical Device. Multi-regional Clinical Trials and Good Clinical Practice (MRCT-GCP), Good Registration Management (GRM), Global Supply Chain Integrity, Advanced Therapies) set by the RHSC with about 9500 participants from regulatory authorities, industry and academia to share information (as of December 2018)
  • Survey on status of international guideline implementation in the APEC region as part of research activities
  • Gap analysis and study on regulations of each APEC member economy to harmonize regulation and build regulatory capacity of developing economies
  • Development and implementation of mid/long-term regulatory harmonization plans with the support for CoE as a lead economy of Pharmacovigilance, Biotherapetuics and Medical Device
  • Publishing Drug Approval System Reports of all 21 APEC economies
  • Online training program on Biotherapeutics and ICH Guideline
  • Survey on Key Performance Indicator (KPI) to measure progress of regulatory converenge in APEC
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