FDA Updates Format for Electronic Submissions Using eCTD Specs

Manufacturers must submit all NDA, ANDAs, BLAs and drug master files electronically by May 15, 2017, and all commercial INDs one year later, under an FDA final guidance.

The updated guidance, which supersedes a 2008 version, describes how drugmakers should organize and file esubmissions using electronic common technical document specifications.

Drugmakers have had the option of submitting applications and master files electronically since 2003, and the majority of submissions are already received electronically.

Tuesday’s guidance says documents such as amendments, supplements and reports must be electronically submitted, even if the original submission occurred prior to implementation of the esubmission requirements. Before making the first electronic submission to an application, manufacturers must obtain a preassigned application number from the FDA.

Submissions that aren’t in electronic format won’t be filed or accepted, unless they have been exempted from the requirements, the agency warns. Exemptions are limited to investigator-sponsor, expanded access and other noncommercial INDs.

More detailed technical instructions will be spelled out in future guidance, the FDA says. The document finalizes a July 2014 draft.

View Providing Regulatory Submissions in Electronic Format —Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications at www.fdanews.com/5-15-FDA-ElectronicSubmissions.pdf. — Jonathon Shacat