Global regulatory agencies gradually implemented, and set a preference for, eCTD submissions over the past decade; rest of the world nations are just now embarking on this path. The EMA and Swissmedic took the most aggressive approach as the first regions to mandate submissions in eCTD format.
The US FDA, on account of a wealth of complexities, not the least of which is the massive amount of sequences it receives and manages, has take a more deliberate approach. But here we are in the homestrech before submissions are required in eCTD format at FDA. The details of what is mandated and when are clear and well known. There is, however, slight confusion surrounding the timeline for Advertising and Promotional submissions.
Post marketing approval promotional submissions, whether professional or consumer, are part of the marketing application lifecycle. They must be included in the May 5, 2017 requirement for all NDA, BLA and ANDA submissions, right? CBER has accepted Ad Promo submissions in eCTD format for years. A distinct change effective as of June 15, 2015, when the FDA switched over to a new Module 1 (DTD 3.3) was clearance for sponsors to submit Ad Promo submissions in eCTD to CDER helped along by an enhanced promotional section 1.15. All of this evidence adds up to a mandate of Ad Promo eCTD submissions, doesn’t it?
The answer is actually no. 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. The draft guidance was published in April 2015. If FDA follows precedent, Ad Promo submissions will be required in eCTD format 24 months after the final guidance is published.
Until the guidance document is finalized, sponsors can submit Ad Promo in paper. If you’re planning to transition from paper to eCTD submissions in this area, please refer to a previous blog titled Q&A – Ad Promo Submissions. While the promotional mandate is not yet set, it’s safe to say FDA is aligning systems, validation criteria and guidance documents with the intent to do so. It would be wise to start thinking about your strategy as well.