In order to fulfill a requirement specified in Section 745A(a) of the Food and Drug Administration Safety and Innovation Act (aka FDASIA), FDA recently issued a draft guidance directing mandatory use of electronic filing and formatting for most regulatory submissions which currently can still be submitted in paper format.
The change is not exactly imminent, but it’s worth getting on the radar, especially since virtually all of FDA’s GDUFA commitments apply only to electronic submissions. The requirements listed in the guidance (more on that seeming contradiction momentarily) will take effect 24 months after the draft guidance becomes final. The statutory section mandating creation of the guidance only specifies the 24 month clock between the final guidance and its effective date, so it’s difficult to predict when the final guidance will actually be issued. As most readers know, there have been draft guidances that have reached high-school age. Still, the comment period for the draft guidance ends September 23, 2014, so technically, things could start happening soon after that.
FDA does spend two paragraphs justifying the absence of the usual “Good Guidance Practice” statement at the beginning of the draft guidance, where FDA usually states that neither FDA nor industry is bound by the guidance, how to interpret the use of the word “should”, etc. This draft guidance states, “…as indicated by the use of the words must or required, this document is not subject to the usual restrictions in FDA’s good guidance practice…” and hence will have binding effect.
What submissions (from those not already required to be submitted electronically, such as registrations and drug product listings) are covered by the guidance? The guidance points back to Section 745A(a) of FDASIA, which includes “…submissions under sections (505) (b), (i), and (j). (Italics added) In other words, just about everything remaining which could be submitted in paper, primarily NDAs, ANDAs and INDs. In a footnote, FDA also pulls in most new Master Files, i.e., drug master files (DMF), biological product files (BPF) and any amendments/annual reports to previously submitted DMFs or BMFs.
Anything not included? FDA lists three exempted submissions
- All submissions regarding devices that are regulated by CBER as biological products under Section 351 of the Public Health Service Act
- Non-commercial investigational new drug applications (including investigator-sponsored INDs, emergency use INDs and treatment INDs)
- Existing Master Files previously submitted in non-electronic format
While these are exempt from the requirements, they may be filed electronically.
The remainder of the guidance provides an overview of the technical components of the required electronic format, i.e., the eCTD specifications. This information is somewhat informative if you have never actually done an electronic submission but provides insufficient information to actually prepare a successful one. Careful review of the extensive reference list would be more useful in this regard. For those who would rather turn the whole electronic submission over to someone else, Premier Consulting has a highly experience e-submission team available.