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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.
A rolling submission is done in waves. Sponsors submit completed sections for review, as opposed to waiting for the entire application to be finished. Smaller portions, as opposed to one large submission, are well suited for projects granted accelerated review timelines. We’re seeing that the means to pull off a rolling submission are available and the awarding of expedited pathway designations is motivating sponsors to proceed with a sense of urgency.
The International Conference on Harmonization recently published a new Specification for Submission Formats for eCTD document. The document achieved ICH step 4 classification, meaning it’s approved for use by all regions. Collapsing bookmarks when documents are opened, a requirement for unique headers or footers on all pages and a limited set of fonts that are recommended for embedding are among the most notable new rules.
Japan’s Pharmaceutical and Medical Devices Agency (PMDA), one of the earliest adopters of eCTD, adheres to a number of unique business rules which create a unique implementation of the eCTD specifications. Information available on eCTD best practices is also limited for this region, primarily due to lower levels of submission activity. What do we already know about submitting eCTDs in Japan and what can we expect later this decade as they implement eCTD v4.0?
Submissions metrics for the US FDA’s new Module 1 shared with industry at the DIA RSIDM 2016 Forum paint a picture of modest activity for the enhanced specification. As of February 1, 2016, 117 companies submitted a total of 1,639 sequences of varying application and submission types.
Rather than submit key information in Module 3 of an application (ANDA, BLA, IND, or NDA), it’s become increasingly common for sponsors to reference a Drug Master File (DMF). Referencing a DMF allows the component manufacturer of the drug or biologic to share proprietary information with the US FDA without having to directly share the information with the sponsor.
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.
Many international regulatory affairs professionals have come to dread the phrase “Module 1 Change” in the past decade. What looks like a simple reshuffling of leaf titles or the addition of a few new submission types grows into a much more complex problem to solve. Those of you in regulatory operations see on thing in large red letters – VALIDATION. The European Union is taking its turn in 2016. The EU M1 v3.0 final specification was published in October 2015 and is set to take effect July 1, 2016. The specifications become mandatory on October 1, 2016.