Regulatory Guidance

FDA: Two Years Until NDA, BLA Electronic Submissions are Mandatory

May 12, 2015


FDA has finalized its guidance document on eCTD submissions, meaning within two years, the agency will require all new drug and biological product submissions to be sent electronically.

Adopted by the FDA in 2003, the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD) allows the FDA received electronic submissions from drug companies.

The final guidance was published in the Federal Register on 5 May 2015, meaning most drug submissions -- including New Drug Applications (NDAs) and Biologic License Applications (BLAs) -- will be required to be submitted electronically by 5 May 2017.

Read the full RAPS article