About 70 life sciences regulatory affairs professionals met in March at the first annual Open eCTD Forum, the first
event held to discuss global acceptance of the eCTD standard. Among the most renowned speakers were Dr.
Timothy Buxton (EMEA/UK), Harv Martens, (ING America, USA), Michel Genot (DGMP, Belgium), Erika Rottey
(MPCA, Belgium), Hans van Bruggen (eCTDconsultancy, Netherlands), Rahul Mistry (GlobalSubmit, USA), Shy
Kumar (Datafarm, USA) and Dr. Thomas Städter (IABG-LSS, Germany).
The event unfolded over three days; the main conference, chaired by Dr. Axel Wenzel (P.SS.T, Germany),
President-elect of TOPRA, was preceded by a workshop on “Compiling eCTDs”, and followed by a user group
meeting, “eCTDmanager”. Company executives and regulatory affairs managers as well as IT managers focused on
optimising information management systems in pharmaceutical and biotechnology regulatory departments took the
opportunity to openly discuss eCTD.
One of the key topics at the event was whether eCTD is truly a globally harmonized standard. Although
representatives of the European, American and Japanese regulatory and industry authorities founded a common
standards organization and launched the ICH (International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use) as far back as 1993/94, “significant regional
differences still exist,” according to Harv Martens. It may take another two or three years until eCTD is identical in
the key regions of the USA, Canada, European Union, and Japan, industry executives agreed. “We are working on
improving the technical message to make it more flexible, so that the same technical message can accommodate
different content requirements,” the President of ING America said.
In the European Union, it was agreed, eCTD certainly will arrive: “Implementation of the eCTD will mean that the
eCTD will be accepted as common currency for product MAAs (Marketing Authorisation Applications),” Mr.Buxton,
Head of Sector Project Management, Communications & Networking Unit with EMEA in London, said. He delineated
the EU's planned schedule: as of the 1st of January 2010, all EU agencies have undertaken to accept electronic-
only eCTD submissions.“
In Belgium, in the heart of the EU, electronic submission is rapidly gaining momentum. Michel Genot, Project
Manager of the DGMP (Directorate General of Medicinal Products) has something to show: he implemented eCTD
in Belgium over a period of only five months. That’s quite an accomplishment. “The DGMP project implementation
was a challenge for all of us,” said Mr. Genot, summing up the lessons learned. “eCDT is a brilliant concept, but it is
not understood by all participants.”
The industry still needs experts like Hans van Bruggen, Managing Director of EN Waalwijk, a Netherlands-based
eCTDconsultancy specialized in regulatory affairs that consults pharmaceutical and biotech companies. At the
open eCTD conference he provided a brief introduction to eCTD lifecycle management. Introducing eCTD means
automating and optimising processes, he notes. Registration renewals can be facilitated more easily under one
condition: “IT requires a consistent document granularity, a consistent and transparent naming convention and an
appropriate use of related sequences and operations.”
“Time moves quickly and once you get used to eCTD and electronic filing in general you make your life easier,”
MPCA advisor Dr. Erika Rottey said. “eSubmissions is the future of the worldwide pharmaceutical business.”
The OPENeCTD Forum was organized by Munich, Germany-based IABG Life Sciences Solutions GmbH (IABG-
LSS), a leading provider of software solutions for the documentation and registration of pharmaceutical and crop
sciences products. The 2006 programme was selected by an independent committee.
The OPENeCTD Forum is to be held annually to promote further discussion among industry professionals.
