Are you familiar with the acronym eCTD? If you answered, “no comprende,” you may want to look that up or it will not only cost you delayed drug submissions, but also time and money. On May 5, 2017, the FDA will require eCTD (electronic Common Technical Document) as the standard format for submitting applications, amendments, supplements and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).
An eCTD submission includes five modules: region-specific information, summary documents, quality-related information, nonclinical study reports and clinical study reports. When materials are submitted electronically, FDA says it is easier to review data, approve new drugs and monitor drugs after they go on the market. Using eCTD also simplifies the process for submitters, because it is the same format used by regulatory agencies in other countries.
So what submissions are affected by the eCTD-format deadline? The new rule applies to all New Drug Applications (NDAs), Abbreviated NDAs (ANDAs) and Biologics License Applications (BLAs). Only Commercial Investigational New Drug Applications (INDs), Drug Master Files (DMFs) and Biological Product Files (BPFs) will have an extra year to make the switch to electronic submissions on May 5, 2018. If a DMF is in paper format with FDA, the same submission does not need to be resubmitted in eCTD format. However, starting May 5, 2018, any new submissions to the existing DMF must be done in eCTD format. The same DMF number can be used.
In addition, the FDA will no longer accept submissions in CD or DVD form. Instead, submissions that total less than 10 GB will need to be submitted via the FDA Electronic Submissions Gateway (ESG), which is the central transmission point for sending information electronically to FDA. The ESG does not open submissions; it acknowledges receipt, routes them to the proper FDA center or office and notifies them of delivery.
The first step to submitting electronically through ESG is to request a test account - fortunately the FDA has provided a handy user guide to help you through the entire process. The process includes a testing phase designed to make sure the agency can successfully receive your electronic submission and that the submission is prepared correctly. Once you pass the test phase, your account will be set up and you’re ready to ride the ESG data super highway. All relevant information and details, can be found at www.fda.gov/esg.
In addition, electronic submissions must include only FDA fillable forms and electronic signatures to enable automated processing. Current FDA forms are available at www.fda.gov.
As with any new, electronic transition, there are bound to be some problems or glitches. According to Jonathan Resnick of the CDER Electronic Submission Support Team, here are the common reasons why eCTD submissions are typically rejected by the FDA: Duplicate submissions, submitted to the wrong center (e.g., CDER instead of CBER), mismatched application/sequence type, invalid file types, and not in standard eCTD format.
According to a White Paper from Master Control, “Five Pharma Trends that Will Have the Biggest Impact in 2017,” most companies’ concerns about the eCTD deadline tend to be related to two main issues: available resources and generics. Soon companies won’t be able to communicate with the FDA without some sort of electronic document management system, and adding electronic solutions will cost money. Plus, besides being a nuisance for manufacturers, many small companies with fewer resources may find the switch more challenging.
Some industry experts predict generic manufacturers may be hit the hardest by the electronic shift because their profit margins are already the smallest. The impact of this will be important in the U.S. market, which will soon represent as much as 80 percent of the profits of all generic drug manufacturers. Thus, companies will need to allocate whatever resources may be necessary to meet the FDA’s new electronic-only submissions policy.
So besides enjoying a refreshing margarita on Cinco de Mayo, we’ll also look forward to the industry’s hard-earned victory conquering the paper mountain.