Active Substance Master File Working Group

The 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 EMA's Committees for Medicinal Products for Human Use (CHMP), the Committee for Medicinal Products for Veterinary Use (CVMP) and 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:

Mandate of the Working Group on Active Substance Master File Procedures

Reference Number: EMA/37869/2022 Rev. 1

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
• Barbara Attenni
• Vera Branquinho
• Hélène Bruguera
• Maria Bruun
• Gary Condran
• Teresa Dannert Alsasua
• Laurens de Leur
• Petra Doerr
• Kora Doorduyn - van der Stoep
• Andria Eliadou
• Zuzana Fliegerová
• ANA-MARIA FRASINEANU
• Laura Galatti
• Stine Grondal Skifte
• Orn Gudmundsson
• CONSTANTIA HADJIDEMETRIOU
• Alexandru Ilie
• Nicole Kavanagh
• Maryam Mehmandoust
• Ana Mimoso
• Mary O'Grady
• Rosemarie Potisk
• Nienke Rodenhuis (Chair)
• Marie-Hélène Sabinotto
• Priscilla Schoondermark
• Dino Soumpasis
• Sabina Uzeirbegović
• Andreea Mihaela Varvara
• Eszter Volgyesine Horvath