Active Substance Master File Working Group

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 Veterinary Medicinal Products (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:


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).


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
  • Barbara Attenni
  • Vera Branquinho
  • Hélène Bruguera
  • Gary Condran
  • Teresa Dannert Alsasua
  • Laurens de Leur
  • Petra Doerr
  • Kora Doorduyn - van der Stoep
  • Andria Eliadou
  • Zuzana Fliegerová
  • Laura Galatti
  • Orn Gudmundsson
  • Anne Kristine Hejlesen
  • Gernot Hirn
  • Alexandru Ilie
  • Nicole Kavanagh
  • Katrine Damkjær Madsen
  • Maryam Mehmandoust
  • Ana Mimoso
  • Mary O'Grady
  • Nienke Rodenhuis (Chair)
  • Marie-Hélène Sabinotto
  • Priscilla Schoondermark
  • Dino Soumpasis
  • Sabina Uzeirbegović
  • Andreea Mihaela Varvara
  • Eszter Volgyesine Horvath