Module 12 2019

History of eSubmission in EU

2005: HMA end 2009 acceptance of eCTD only in EU 2008: NeeS mandatory in some countries 2010: EMA implements eCTD only for CP November 2011: TIGes discussion for the need of clear guidance on the future of eCTD and eSubmission

ROADMAP!!!!

The Organisation for Professionals in Regulatory Affairs

Slide 12