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EDQM

European Directorate for the Quality of Medicines & Healthcare (EDQM)

Background

  • Conclusion of MOU to exchange information and establish cooperation system with regard to specifications for medicinal products, testing and analysis, advanced control of reference standards and safety control

Introduction

  • A European organization related to quality control of medicinal products responsible for publication and distribution of European Pharmacopoeia (EP) and other documents, identification tests and analyses, control and distribution of reference standards for medicinal products and biologics and researches to support safety control of medicinal products

Cooperation areas

  • NIFDS/EDQM joint workshop, training program and technical cooperation and sharing of information on establishment and control of reference standards
  • Technical cooperation and sharing of information on proficiency testing and quality assurance among laboratories (e.g., OMCL)

    ※ OMCL: Network of Official Medicines Control Laboratories

  • Training and interchange of personnel between the two organizations

Key activities

  • Participation in proficiency testing held by EDQM (from 2011)
  • Ph. Eur. Commission observership (October 2015)

    ※ Ph. Eur. Commission: Ph. Eur. Commission makes decisions relating to European Pharmacopoeia with participation of 37 EU member states, EU agencies (EDQM and EMA), 25 observer countries and WHO.

  • Training and interchange of personnel (from October 2015)

    ※ Short-term dispatch to EDQM (November 2015 to May 2016, to study techniques for testing and evaluation of medicinal products' quality risk factors with regard to reference standards and European Pharmacopoeia)

  • Holding of and participation in joint workshops, symposia, and training sessions (six times)

    ※ Holding of NIFDS/EDQM joint workshop (2011, 2012), participation in international symposium on reference standards (2012), participation in EP training program (2011, 2014), participation in EDQM workshop (2014)

  • International joint research on reference standards (2011, 2013, 2014)
  • Visit to EDQM and discussion of MOU follow-up actions (2014)
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