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.
In recent weeks, sponsors filing eCTD submissions to FDA have reported instances of Refuse to Receive (RTR) notifications for failure to provide a fillable Form 3674. These actions indicate that the Agency is stepping up enforcement in this area as it aims to process even more submissions automatically. Using industry presentations and guidance documents, FDA has previously stated that sponsors “must” include fillable forms. The Agency has also made it clear that scanned images of FDA forms “will not be accepted.” Based on the information made public by FDA to date and the experience of sponsors in recent months, the most logical strategy moving forward is to provide a fillable form where one is available.
Many people erroneously believe that your first eCTD submission is restricted to a major milestone application – Investigational New Drug (IND) application, Biologics License Application (BLA) or New Drug Application (NDA). That’s simply not the case. It’s 100% possible to file pre-NDA meeting requests, meeting packages and meeting minutes via eCTD in advance of the original NDA submission.
Almost five years ago, I wrote a post outlining the process for converting a paper application into an eCTD application with FDA. As the saying goes, the more things change, the more they stay the same. Here we are in 2016, and, to the surprise of some and the consternation of many, paper applications are still alive and well. However, their days are numbered, with FDA’s eCTD mandate for certain application types set to take effect one year from today.
The FDA requirement to submit in eCTD format as of May 5, 2017 does not apply to Ad Promo submissions. As of today, the timeline for requirement of these submissions in eCTD is to be determined. Similar to the majority of regulatory requirement updates at FDA, the date effective clock doesn’t start counting down until guidance is finalized. The key indicator for Ad Promo eCTD submissions is the document titled – Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs. If FDA follows precedent, Ad Promo submissions will be required in eCTD format 2 years after the final guidance is published.