No More Paper: FDA to Accept Only Electronic Documents for Most Submissions
[Posted on: Friday, May 4, 2018] This Friday, the 4th of May 2018 is the last day FDA will accept most submissions to CDER and CBER and several to CDRH in paper format. Starting 5th of May 2018, almost all INDs, market approval applications, most DMFs, except Type III DMFs, can only be submitted electronically. Also all amendments, request for meetings, all submissions to these applications can only be done electronically in the eCTD format on FDA’s Electronic Submission Gateway (ESG). The implementation of the e-submission program has been going on for the last 5 years, and most commercial entities have already converted to electronic submissions. The academic and non-profit/government agencies may be lagging behind. Non-commercial entities can still submit paper INDs but not market approval applications. Similarly most DMF holders have converted the electronic submission format over the last few years. The vendors located outside the US, many raw material providers and other component providers may be lagging behind. Most of those companies will be unable to submit their documents to the FDA. It is projected that in the next 5 years or less, FDA will move almost entirely to the electronic submissions only format. Almost all FDA registrations moved to online forms in the last few years. Even though CDRH has not formally announced similar hard dates for accepting only electronic documents, it had required e-copies of all paper submission for several years, so in effect it will be an easy transition to have the e-copies submitted online, likely through the ESG as well. This is not a new information, FDA has been announcing these dates for at least 2 years, still the actual date of compliance is a major milestone for the FDA.
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