The eCTD summit

Rob de Haan, deputy director at MEB, spoke about the status of eCTD at MEB, and also presented a variety of EU statistics, many of them updates from the eCTD Implementation Survey Report published in December of 2008.

MEB now has a full e-working environment (although they make almost no use of their eCTD viewer, for reasons Rob didn’t go into).  eSubmissions (eCTD and NeeS) for human medicines are mandatory.  Case managers and assessors have secured access to electronic files in a central repository, and thus can work remotely (through Citrix) without downloading files.  Veterinary submissions are still on paper.  eSubmissions are via CD or DVD now as MEB does not yet have an electronic gateway.

Europe is making slow progress toward the goal of all agencies excepting eSubmissions without paper by the end of 2009.  Currently 15 out of 32 agencies are ready (up from 13 six months earlier).  Agencies report receiving 54% of all submissions electronically in Q3/Q4 2008, out of a total of 203,941 submissions.

When broken down by submission type, the total percentage by format was as follows:

·         6% eCTD (up from 3% in Q1/Q2)

·         58% NeeS (down from 62% in Q1/Q2)

·         31% Other (down from 33% in Q1/Q2)

[not quite sure why the totals only add up to 95% or why eCTD+NeeS at 64% is much higher than the total of 54% electronic reported in the previous paragraph, but you get the idea!]

At this point, DCP/MRP are about 54% electronic, NP about 50% electronic, and CP almost 100% (see my previous post for EMEA experience).

Rob’s observation is that NeeS will eventually disappear and no longer be accepted by the individual HAs.  This won’t happen right away but validation will continue to get tougher, with HAs adding more rules and moving to zero tolerance.

Most agencies really want to move to eCTD, but obstacles remain such as pushback from the sponsors (who sometimes say that NeeS is easier than eCTD).  In addition, some regulators don’t want to have to train reviewers and install review tools.   Finally, of course, some countries don’t have a legal basis at this time for accepting electronic documents as official or archival copies in lieu of paper, and there is only so much the HAs can do to push legislation.