EMEA announces plans for electronic-only marketing submissions
Published 05/02/2008
The European Medicines Agency (EMEA) has unveiled plans for a phased approach to the acceptance of electronic-only and eCTD 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
很关注
注明消息来源是否更好?
源于EMEA的网站
Published 05/02/2008
The European Medicines Agency (EMEA) has unveiled plans for a phased approach to the acceptance of electronic-only and eCTD 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
很关注
注明消息来源是否更好?
源于EMEA的网站