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.
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 U.S. FDA and Health Canada have each updated their submission requirements for Drug Master Files (DMFs). Understanding each agency’s requirements will be critical to compliance in the coming months as eCTD mandates go into effect.
The most frequently asked question related to the conversion from paper to eCTD is, “Are we required to resubmit everything we’ve previously submitted in paper to the ‘new’ eCTD application?” Thankfully, FDA does not require you to resubmit information that was previously submitted in paper. However, you may find it useful to occasionally “backfill” your eCTD application by resubmitting previously submitted information for the convenience of the FDA reviewers.
People seeking advice on eCTD publishing best practices usually fall into one of two groups: (1) Sponsors who are new to eCTD, for example, medical writers or project managers (2) eCTD publishers. The first group is usually interested in specific actions they can take to make their specific submission a success, while the latter group is more interested in strategic ideas on how to make their processes work better for all submissions.