Module 12 2019

eCTD mandatory use in Europe

• CP: since 2014 • Initial DCPs: since July 2015 • RUP: since January 2017 • MRP maintenance: from January 2018 • Initial NP: from Mid 2018

• January 2019: mandatory for all submission => baselines to prepare, amending processes with local affiliates?

The Organisation for Professionals in Regulatory Affairs