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NEW RULES FOR ASSESSMENT OF KNOWN ACTIVE SUBSTANCES
Session Chair(s)
Christa Wirthumer-Hoche, PhD
Chair, EMA Management Board, Head
Austrian Medicines & Medical Devices Agency (AGES), Austria
The same Active Substance Master File (ASMF) is often used in different dossiers for multiple procedures assessed by different assessors. Currently there is no common platform/repository for information on ASMFs in Europe, which may result in divergent assessments and a list of questions. Furthermore, ASMF and related ARs are kept and managed by each NCA individually, possibly lacking awareness of the same ASMF having been assessed in another NCA which can result in duplication of work and inefficient use of assessor resources. A new EU ASMF numbering system will help to identify identical dossiers. Information will be given about the project, setting up an ASMF-AR repository and starting a work sharing procedure for ASMF assessment. At the EU level we also have the CEP-procedure. Closer cooperation and exchange of ARs is ongoing. Industry will also present its point of view concerning this harmonised assessment and the principle of work sharing.
Speaker(s)
ASMF-Work Sharing in the EU - Will it work?
Christa Wirthumer-Hoche, PhD
Austrian Medicines & Medical Devices Agency (AGES), Austria
Chair, EMA Management Board, Head
Provision of CEP Assessment – Options for harmonised review
Susanne Keitel, DrSc, RPh
European Directorate for the Quality of Medicines & Healthcare (EDQM), France
Director
Expectations of Industry in Respect to Harmonisation of ASMF Documentation
Marieke Van Dalen
Merck Sharpe and Dohme, Netherlands
Associate Director Regulatory Affairs
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