Electronic Submissions of New Drug, Biologic Files in Next Two Years

New FDA Update!!!

Over the next two years FDA may require all new drug and biologic submissions to be sent electronically. FDA will adhere to the International Conference on Harmonization’s (ICH) electronic common technical document (eCTD) format. Adoption of this format will allow companies to submit an application for a new pharmaceutical or biological product to multiple regulators. This change was outlined in 2012 within the Food and Drug Administration Safety and Innovation Act (FDASIA), mandating electronic submission two years after finalization of an eCTD guidance document. The guidance document, found here: eCTD Guidance, was finalized in May 2015, starting the 2 year countdown. FDA will not file or receive documents that do not adhere to this mandate unless exempt.

? Email us at info@mdiconsultants.com if you have further questions. Ref: eCTD Mandate