FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Postpones eCTD Requirements for Drug Master Files by One Year

April 14, 2017

Less than a month shy of mandating electronic submissions of drug and biologic master files in the eCTD format, the FDA has decided to postpone the requirement until May 2018.

Following industry comments and internal reviews, the FDA felt requiring the electronic format for master files by May 5 of this year could have led to high rejection rates and delayed reviews.

NDAs, BLAs and ANDAs must still be submitted in the eCTD format after May 5. Commercial INDs, and now master files, must follow the requirements after May 5, 2018. Noncommercial INDs are exempt from the requirements.

Submissions that are not electronically submitted in the proper format will not be filed or received, the FDA said. The requirements also apply to application amendments, supplements and reports. The agency plans to cover the electronic submission of advertising and promotional materials in a separate guidance.

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