A joint working group comprising representatives from EU Regulatory Authorities, The European Medicines Agency, industry, EDQM and ASMF holders has drafted a guidance document covering practical and technical points related to the submission and handling of the ASMF in eCTD. As this is a final draft, the guidance should be implemented, but as experience with eCTD and ASMF is gained, comments are actively sought, with a view to updating the guidance as necessary in July 2010. (source:http://esubmission.ema.europa.eu/doc/index.html)