EU eCTD M1 Draft Specs v3.0 for Public Consultation

The EMA released the EU eCTD M1 Draft Specs v3.0 for Public Comment on 24-Jul-2015 (http://esubmission.ema.europa.eu/eumodule1/index.htm). The Comment Template can also be found at the same location.

The final version of the specification should be published no later than end of September 2015. It is foreseen, that the specification should come into force at July 1, 2016 with optional use, and will become mandatory by October 1, 2016.


If you would like to provide comments as part of the general IRISS response, please join the GSO topic group meeting on August 20th for further details.