Europe Working to Establish Electronic Submission Gateway

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I caught up with Tim Buxton of EMEA at the DIA meeting in June. Tim’s big news is that EMEA’s Electronic gateway will be operational shortly, although he could not release a date. The gateway has already been tested with a variety of submissions.

Tim stressed that the EMEA is serious about enforcing the use of eCTD and no longer accepting NeeS as of the published 1 January 2010 deadline. He mentioned that forward-looking companies are already looking beyond eCTD and asking him about RPS.

In Tim’s presentation, he mentioned that the eAF (electronic application form, which is an XML form) will be ready by the end of the year. EMEA is finalizing their receiving tool as well as an authoring tool that will be available both on-line and stand-alone.

In the area of PIM, they are finalizing a stand-alone light authoring tool that will be downloadable from their web site. Although they are still working out kinks in the pilot project and are not ready to make PIM mandatory yet, Tim said that “it won’t be too long” – just the push that sponsors have been waiting for… in the meantime, EMEA will assist sponsors in converting.

Next post, news from the MEB and European statistics…

Author: GS

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