OK, OK - we have taken our fair share of swipes at the seemingly endless problems that the EU is having in moving to electronic submissions. Delays in PIM, lack of enthusiasm on the part of pharma companies, and now this:
The latest status report [PDF link] for EMA's Electronic Application Form Project starts out by stating
Project has been delayed by up to 9 months due to the resignation of the project managerA replacement team (yes, team - apparently the entire development and test team followed the PM out the door) has been hired and new deadlines have been set. While this can and does happen on projects, it is becoming embarrassing to witness the endless parade of problems around European eSubmissions.
[Thanks to exalon for the heads-up!]
Well, since you have some time to get up-to-speed on eSubmissions and eCTD, here are five excellent resources for you:
- Electronic Submissions in Europe – eCTD and non-eCTD Submissions (NeeS)
- Regional file format requirements for eCTD
- Lifecycle Management of the eCTD and NeeS in Europe
- Free CTD/eCTD templates
- Effective eCTD Regulatory Strategy and eCTD Lifecycle Management
ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.