Submissions that are not sent electronically or in a format that FDA can process, review, and archive will not be filed or received, unless exempted from the electronic submission requirements.
The electronic submission requirements will go into effect on:
- May 5, 2017 for NDAs, ANDAs, BLAs, and master files.
- May 5, 2018 for commercial INDs. (Noncommercial INDs are exempt.)
A notable change from the draft guidance document is the inclusion of master files under the electronic submission requirements. FDA considers master files to be submissions to an NDA, ANDA, BLA, or IND, such as DMFs (new drug master files), BPFs (new biological product files), and any amendments to or annual reports on previously submitted DMFs or BPFs.
This guidance document outlines electronic submission specifications and provides links to technical specification documents. Further and more detailed technical instructions will be included in a separate eCTD technical conformance guide.
Contact RPI for assistance in meeting FDA’s new electronic submission requirements.