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Posted 12 February 2013 | By Alexander Gaffney, RAC,
US Food and Drug Administration (FDA) officials have announced the availability of newly revised final documents that describe the recommended process for regulatory professionals to use when submitting electronic versions of the Common Technical Document (eCTD), including a curious update regarding the submission of information on medical device submissions.
The eCTD is a standard developed and implemented by the International Conference on Harmonisation (ICH), an international regulatory harmonization group focused on pharmaceutical and biological products. The standard is meant to streamline the application process for regulatory dossiers, allowing sponsors to more easily prepare a submission for regulatory review in the EU, US and Japan. Modules 2, 3, 4 and 5 of the eCTD are common to all regions, while module 1, the regional administrative information module, is not.
Since 2008, FDA has expressed its preference for the eCTD, and a recently-released draft guidance document explains that the agency will soon require sponsors to submit their applications in the form of an eCTD.
The two documents described in FDA's 12 February Federal Register notice, "The eCTD Backbone Files Specification for Module 1, version 2.1" and "Comprehensive Table of Contents Headings and Hierarchy, version 2.1," are part of a broader effort by FDA to keep electronic submissions up to date and compliant with regulatory changes.
The former document "provides specifications for creating the eCTD backbone file for Module 1 for submission to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER)," FDA explained. "It should be used in conjunction with the guidance for industry entitled Providing Regulatory Submissions in Electronic Format--Human Pharmaceutical Applications and Related Submissions which will be revised as part of the implementation of the updated eCTD backbone files specification."
The latter, meanwhile, "reflects updated headings that are specified in the document entitled 'The eCTD Backbone Files Specification for Module 1, version 2.1.'"
Neither document is currently online for directly viewing at the time of this article's publication, but typical FDA practices indicate that they are likely to be posted within approximately 24 hours.
Notably, FDA explained that the document has been updated to include reference to Premarket Approval (PMA) applications and 510(k) submissions, both of which are used almost exclusively for medical device submissions.
"The application-type attribute file was modified to include PMA and 510(k)," the document states.
As the result of recent FDA guidance on combination products, it is possible that the agency is merely facilitating the submission of combination product submissions, but it could potentially be a sign that the agency might soon accept medical device submissions in electronic format.
A scan of the existing eCTD backbone files specification for Module 1 file found no mention of either PMAs or 510(k)s. FDA's currently-accepted list of application types, found as a file on its website, includes no mention of PMAs of 510ks either-just drug-type submissions.
The new versions are not yet operational in that FDA is currently unable to receive them, but says it expects to be able to starting in September 2013, and explained that it will give 30 days of advance notice to the pharmaceutical industry.
Regulatory Focus has reached out to FDA contacts for clarification on the meaning of this language.
Editor's note: We just heard back from Constance Robinson, Regulatory Information Specialist at FDA.
"Certain application types (IDE, PMA, 510k) are only
to be used with the cross-reference-application-number element as indicated in
the comment in the application-type.xml file," Robinson said in an email, quoting from the new file.
The files are now online here.
Tags: pharmaceutical, 510(k), eCTD, PMA, drug, medical device
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