With the mandatory requirement for eCTD approaching, Shylendra Kumar of Datafarm Inc considers the change from paper CTD to the electronic version, and takes a look at what’s available to help ensure readiness and eCTD compliance
Depending on where you operate in the world (especially if you are filing regulatory submissions in the US, EU, Japan or Canada), the eCTD will become a major part of your working life in the very near future, if it isn’t already. In Europe (except for the UK and Belgium, who already require either eCTD or another form of electronic submission) there is a commitment that agencies should be ready to accept eCTD submissions with no accompanying requirement for paper by the end of December 2009. In the US eCTDs are already being accepted and will effectively become a requirement from January 2008. In Japan it is optional and in Canada hybrid eCTD submissions (part paper CTD and part eCTD) have been accepted since 30th June 2006, with plans to accept a complete eCTD, although the deadline has not yet been established by Health Canada.
KEY BENEFITS
The common structure across regions will significantly reduce content preparation time and enable reusability across the regions. The cross-referencing of a single physical document from multiple locations within the submission structure, and across submissions within the application, should eliminate duplication of content submitted to agencies.
For ‘usability’, the navigation offered by an eCTD will make it easy to find a specific document or piece of information in any application. The ‘life cycle management’ aspects make it easy to determine the status of a document without reading the content; and with no system dependency, the interoperability of the eCTD will enable easy export and import between systems.
HOW TO FIND THE RELEVANT SPECIFICATIONS
Relevant eCTD specifications for your individual needs can be found at the ICH website (1), ICH party websites (EMEA, FDA, MHLW and Health Canada) as well as national agencies websites. The ICH controls overall standards and provides specifications for Modules two through five. Module one contains regional content and specifications provided by regional agencies (FDA, EMEA, EU agencies, MH and Health Canada).
EARLY ADOPTION: THE PROS, CONS AND CHALLENGES
A survey conducted in 2005 (covering US and European pharmaceutical companies), reported that 19 per cent of respondents had already been, or were in the process of migrating, and one-third of the respondents (32 per cent) planned to migrate to the eCTD within 10 to 18 months (2).
We’re not seeing a ‘typical’ early adopter of the eCTD; it all depends on the organisation, its involvement in, and commitment to being a front-runner by taking advantage of new agency initiatives.
