Active Substance Master File Working Group

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The Joint Committee for Medicinal Products for Human Use/Committee for Medicinal Products for Veterinary Use/Coordination Group for Mutual Recognition and Decentralised Procedures – Human/Co-ordination Group for Mutual Recognition and Decentralised Procedures – Veterinary Working Group on Active Substance Master File Procedures (ASMF WG) provides advice on the procedural aspects of the assessment of active substance master files (ASMFs) to the Committee for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP), the Coordination Groups for Mutual Recognition and Decentralised Procedures (CMDh and CMDv).

The Working Group's main tasks include:

  • considering the feasibility of a worksharing procedure for ASMF assessments;
  • developing a procedure for a co-ordinated and harmonised use of ASMF assessments;
  • developing a European Union numbering system for ASMFs;
  • developing a centralised database for all ASMF assessment reports;
  • considering how the ASMF assessment procedure can be improved and optimised.

Mandate, rules of procedure and work programme

More information on the ASMF WG's responsibilities and composition are available in this document:

Composition

The ASMF WG is composed of members of the CHMP, CVMP, CMDh and CMDv, as well as representatives from the European Medicines Agency and the European Directorate for the Quality of Medicines and Healthcare (EDQM).

Members

Below (in alphabetical order of surname) are the current members of the ASMF WG. The members' declarations of interests are available in the European expert list.

  • Mioara Andrei
  • Alessandro Assisi
  • Peter Bachmann
  • Hélène Bruguera
  • Teresa Dannert Alsasua
  • Kora Doorduyn - van der Stoep
  • Laura Galatti
  • Beate Gasser
  • Ada Alexandra Georgescu
  • Elspeth Gray
  • Nicole Kavanagh
  • Susanne Keitel
  • Katrine Damkjær Madsen
  • Maryam Mehmandoust
  • Judit Pandi
  • Margit Plakso
  • Maureen Riach
  • Jean-Louis Robert
  • Nienke Rodenhuis (Chair)
  • Wilhelm Schlumbohm
  • Dino Soumpasis
  • Susanne Stotter

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