The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of premarket and postmarket regulatory information for review. It is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach the proper FDA Center or Office. Creating an ESG account requires many steps. This post provides helpful tips for the successful creation of your ESG account.
The Affordable Care Act requires pharmaceutical companies that dispense drug samples to physicians and health care professionals to report annually on the details of the samples dispensed. The government mandated this electronic reporting of all drug samples annually, by April 1 each year. The intent of the legislation is to help FDA monitor prescription drug distribution activity and prevent abuse.
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.
More than 3 million submissions were received via the ESG in 2015, and FDA representatives are estimating 7 million submissions for the year 2016. The volume increase is quite substantial considering 11.3 million submissions passed through the ESG in the previous 10 years (January 2006 to January 2016). Small user improvements planned by the FDA, and announced at DIA RSIDM 2016, will make life easier for sponsors who are growing more dependent on their Gateway accounts.
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.