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ICH

International Council on Harmonization (ICH)

Introduction

  • Establishment and spread of internationally harmonized guidelines on all aspects, including review/approval and post-marketing surveillance
  • Harmonization of submission dossier format (common technical document (CTD, e-CTD))
  • Development and maintenance of MedDRA, an international medical terminology dictionary used by regulatory authorities for authorization and safety monitoring of medical products

Scope of Activities

  • Participation in ICH meetings as the Korean regulatory authority to share information on the regulation of medical products in Korea, and comments on ICH related issues
  • Participation in ICH meetings as the regional harmonization initiative (RHI) representing APEC to share information on the regulation of medical products in the APEC region, and comments on ICH related issues
  • Participation in IPRF meetings to present regulatory activities in Korea, collect information and discuss action plans as the chair of the biosimilar working group
  • Participation in ICH expert groups as the Korean regulatory authority to be involved in the development of guidelines

Key activities

  • Participation in ICH management committee (previously steering committee) as a representative of the APEC region (Since May 2007 to the present)
  • Participation in ICH management committee (previously steering committee) as the Korean regulatory authority (Since June 2008 to the present)
  • Participation in ICH expert groups (EWGs, IWGs) as the Korean regulatory authority to jointly develop ICH guidelines (Since June 2011 to the present)
  • Participation in many activities and meetings as the chair of the IPRF biosimilar working group (Since November 2013 to the present)
  • Became an observer after organizational changes of ICH (January 2016)
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