When submitting nonclinical study reports in regions using Study Tagging Files (STF), the duration of the study is one common piece of metadata that must be provided. The ICH eCTD STF Specification provides three options to choose from – short, medium, and long. But the ICH eCTD STF Specification doesn’t define the time periods covered by these three duration options.
Optimizing Regulatory information management (RIM) is something every pharmaceutical company must plan for. Defining RIM can be a challenge, however, since there’s no ICH standard for what should be done. But right now your organization is dealing with the reality of managing several drug submissions weekly for multiple medicinal products. That includes keeping track of the regulatory activities associated with these submissions, attempting to manage agency commitments, and organizing and sharing the daily updates of agency correspondence. Without a central hub to capture critical regulatory data and turn that data into actionable intelligence, your business is at risk of missed deadlines, delayed market approval, and non-compliance.
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 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.