On December 15, 2015, the International Conference on Harmonization (ICH) endorsed Step 4 of the eCTD v4.0 Implementation Package v1.0. Step 4 signals that major stakeholders agree on guidance. ICH released its implementation guide in early April 2016 and regulators in the US and EU followed suit. Industry is taking very real steps to implement eCTD v4. I’ve compiled a list of expectations on timing and impact for eCTD v4.
The evolution of the Electronic Common Technical Document (eCTD) has been a progression. More features and functionality become available to users as new versions are introduced. User adoption of eCTD also increases year over year. FDA Module 1 v2.3 (DTD 3.3) is a bridge to eCTD 4. A number of functionality enhancements set for inclusion in eCTD v4 first appeared in the new FDA M1 but were not present in FDA eCTD M1 (DTD 2.01). The shared features, presently implemented in FDA M1 v2.3 (DTD 3.3) and included in eCTD 4, are coded metadata, in the form of Controlled Vocabularies, and Grouped Submissions.
The focal points of eCTD v4.0 like document reuse, enhanced lifecycle control and more liberal use of metadata, and the ability to alter that metadata if errors are made, are countermeasures to the limitations of eCTD v3.2.2. Overall, these enhancements represent common sense solutions that give regulatory professionals a more efficient way of doing business.
Much fanfare has surrounded the Next Major Version (NMV) of eCTD or eCTD 4 since the group I chaired formed in 2005 and developed initial requirements for the standard. You’ve likely sat in on eCTD 4 presentations at industry conferences and heard secondhand of the deliberations, ballots and revisions going on behind the scenes. In short, we’ve all been waiting for things to happen. Well, things have happened. As a member of the Expert Working Group (EWG) first tasked with developing eCTD 4, I’m proud to report that agencies, vendors and sponsors in each ICH region can get started on implementation. ICH announced that it had reached Step 4 and adopted a harmonized guideline on the eCTD 4 Implementation Package for Modules 2 through 5. Let’s review some of the key concepts of eCTD 4 to get an idea of what will change when this standard is implemented down the road.
The true challenge of eCTD migration is your impact analysis (i.e. downtime, architectural changes and environmental changes) and determining whether or not your selected vendor supports unwritten Agency rules. Bear in mind that subtle differences exist among vendors who have implemented eCTD systems. You need to ensure that your chosen vendor has experience migrating submissions, not only from your existing system, but from all systems that generated eCTD that you now have to manage.