EU: New draft eCTD guidance for ASMFs released

A new Guidance detailing practical and technical points related to the submission and handling of an ASMF (Active Substance Master File - previously also known as European Drug Master File, EDMF) in eCTD format has been drafted by a joint working group comprising representatives from EU Regulatory Authorities, the EMA, industry, EDQM and ASMF holders.

The Guidance is available as final draft version and comments from stakeholders are actively sought. The objective is to update the guidance as necessary in July 2010. Comments should be sent to esubmission@mpa.se.

In addition, an example eCTD for an ASMF has been prepared to better demonstrat3 the proposed organization of the file/folder structure, leaf titles and XML attributes for the open part and the restricted part.

[Source EMA/TIGes website]

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