Are you currently submitting eCTDs (electronic common technical documents) to European Region (EU)? Or planning for the same in near future? Then we suggest it’s time to pull up your socks as the EU is taking its turn in 2016. As we could decode the details from EU M1 eCTD specification – V 3.0, which was published in the last quarter of 2015, the final version is set to take effect from 1st July 2016 and is set to be mandatory from 1st October 2016.
What companies should realize about the new specification, Module 1 change, is the complexity for it’s: