EMEA announces plans for electronic-only marketing submissions

The European Medicines Agency (EMEA) has unveiled plans for a phased approach to the acceptance of electronic-only and eCTD ([[Electronic Common Technical Document]]) applications in support of marketing-authorisation applications for medicinal products in the centralised procedure.

Planned milestones are:

• Until 1 July 2008, the current guidance remains in force
• From 1 July 2008, the EMEA will accept electronic-only submissions, either in eCTD format or non-eCTD format
• From 1 January 2009, the EMEA will strongly recommend electronic-only submissions, either in eCTD or non-eCTD format
• From 1 July 2009, the EMEA will strongly recommend eCTD-format electronic-only submissions

Further details are available in the announcements and guidelines linked below:

• EMEA Announcement and EMEA Question and Anwers
• ICH: eCTD Information (including all guidelines from ICH)
• ICH: eCTD Specification Details (Downloads: common XML stylesheet, folder structure program)
• FDA ESG Example for digital signature
• EMEA: TIGes (including XML stylesheets for download etc.)
• ([[Electronic Common Technical Document]])