For Pharmaceuticals:

DIA's 43rd Annual Conference Looks at Impact of New FDA Requirement for Electronic Submissions
By Lane Hirning

After December 31, 2007, all new electronic submissions must conform to eCDT format.

For well over a decade, there has been an initiative by the International Conference on Harmonization (ICH) to standardize formats for new drug applications in the U.S., Europe, and Japan (where the majority of new medicines are developed).  In the past, the format and organization of submissions varied by country, which made it difficult and time-consuming for a U.S. drug company, e.g., to submit an application for drug approval in Japan or the United Kingdom, and vice versa. A common format provides the ability to reuse portions of a submission in submissions to other markets.  It also provides ease of update and revision for the sponsor, thereby decreasing the time and resources required to create submissions, as well as resubmissions to other markets. Another advantage is that a more predictable format might possibly decrease the time required for agency review, as well as promote more consistent reviews. 

The ICH Steering Committee presented its finalized Common Technical Document (CTD) in 2000. The EMEA adopted the CTD format in 2001, Japan in 2003, and Canada in 2005.  As early as 2001, the FDA provided guidelines for companies who wished to use the CTD format, but the FDA has never said anything about requiring companies to use it until recently.  This announcement came last year in two parts. The first part was the April 2006 guidance updating the specifications for providing electronic submissions in eCTD format. The second part came in September in the form of the withdrawal of all other electronic submission guidances, and the notice that all references to the other electronic formats would be removed from the docket at the end of the year. What this means is that all new FDA electronic submissions (but not paper submissions) must conform to the eCTD format after December 31, 2007.

Exactly how this affects pharmaceutical companies was one of the main topics of conversation at the DIA’s 43rd annual meeting, held recently in Atlanta.  Much of the discussion centered on dispelling a couple of major confusions.

  • One was that the FDA was now going to require electronic submissions.  This is not true.  While certainly, the FDA prefers electronic submissions, at present they do not require them, and they have not indicated when they might start doing so in the future.  What last year’s announcements have told us is that, if you’re going to submit electronically after December 31, 2007, then you must use the eCTD format. 

  • The other confusion had to do with companies who submit electronically using a format other than eCTD before the December 31, 2007 deadline—in other words, companies who have a submission in process on January 1, 2008.  Will these companies be required to use the eCTD format for subsequent filings related to the submission that was filed prior to December 31, 2007?

    According to CDER, the answer is no.  After the December 2007 cutoff, companies who file electronically are required to use the eCTD format for all new submissions; and a submission in process on January 1, 2008 is not considered a new submission.  

Besides making it easier for the FDA to review electronic submissions, the eCTD format will make it easier for U.S. pharmaceutical companies to submit applications for drug approval in Europe, Japan, and Canada.  And, of course, it will enable U.S. companies to reuse the domestic application, resulting in potential time and cost savings.

The FDA has maintained for some time that receiving information in a consistent electronic format would help make more effective use of important drug information, especially pertaining to safety. The September announcement was the first time, however, that the administration has come out and said—okay, from now on (after December 2007 for all new electronic submissions), we’re going to have one format and this is what it’s going to look like.  (It should be noted that CBER, in contrast to CDER, has not withdrawn the older e-submission guidances.)

About the Author
Lane Hirning, a product manager at MasterControl Inc., is a pharmacologist with extensive IT experience in the pharmaceutical industry.

Read about the FDA regulations pertaining to eCTD format::

White Paper:

21 CFR Part 11 Risk of Non-Compliance

White Paper:

21 CFR Part 11 Product Positioning

White Paper:

5 Ways MasterControl Ensures System Compliance with 21 CFR Part 11

Click here to view all available resources.

If you are a current MasterControl customer click here to download documents directly through our Customer Center.


FDA Links

  • Dockets for Guidances on Providing Regulatory Submissions in Electronic Format; Withdrawal of Guidances.

  • Guidance for Industry: Providing Regulatory Submissions in Electronic Format ? Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.

  • Docket for Electronic Submission Public Hearing.

Additional Articles