EMA: eCTD Mandatory Format for ASMF Submissions for Human Medicines as of July 1, 2016

From 1 July 2016, the use of the eCTD format for all ASMF submissions for human use in the centralised procedure will become mandatory. After this date, it will no longer be possible to submit human ASMF submissions using the NeeS format to EMA. After this date, it will no longer be possible to submit human ASMF submissions using the NeeS format to EMA.

“Statement of intent on the mandatory use of eCTD for human centralised procedure ASMF submissions”:http://esubmission.ema.europa.eu/eASMF/Mandatory%20eCTD%20for%20Human%20centralised%20procedure%20ASMF%20submissions%20-%20Statement%20of%20Intent.pdf