A long-awaited draft guidance requiring the submission of most pharmaceutical and biological product applications to be done using the electronic common technical document (eCTD) standard has been released by the US Food and Drug Administration (FDA).
The 3 January 2012 release of the document, Draft Revision of Guidance for Industry on Providing Regulatory Submissions in Electronic Format-Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, was required by the FDA Safety and Innovation Act (FDASIA), a piece of legislation passed last year containing a wide array of reforms and changes to FDA.
In a Federal Register announcement explaining the guidance, FDA noted that it has been receiving submissions in the eCTD format since 2003, and has recommended their use since 2008. "The majority of new electronic submissions are now received in eCTD format," FDA noted, though it did not explain whether the majority of all submissions are electronic.
Under the draft guidance, all 505(b), 505(i), 505(j), 351(a) and 351(k) product-that is, pretty much every pharmaceutical, generic pharmaceutical, biologic or biosimilar product submitted to the agency-will be required to submit data to FDA using the eCTD format starting no later than two years after the publication of the final guidance in the Federal Register. Based on typical timelines for the issuance of draft and final guidances, that mandatory compliance date is likely to occur in mid-to-late 2015.
The implementation of the eCTD requirements will be phased in, with new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics licensing applications (BLAs) required within 24 months, and investigational new drug applications (IND) submissions due in eCTD format 36 months after the final guidance is published.
Notably, the guidance will not make the same requirements of drug master files (DMFs) or promotional labeling submissions, though FDA said it "accepts and strongly encourages the submission" of both on a voluntary basis.
The guidance is also unusual in that Congress specified that it needed to establish a legally binding submission format (eCTD 3.2.2.). Under normal circumstances, guidance documents cannot, by law, establish legally enforceable responsibilities. The other parts of the draft guidance are still not legally enforceable, FDA noted.
The actual text of the guidance was not available at the time of this article's publication. In correspondence with FDA, Regulatory Focus was told that its non-publication was a "glitch" and that they expected the document to be posted at some point on 3 January 2012. [Editor's note: it's now online here.]