Clinical Trial Disclosure Community

Subject: Implementation of Clinical Trial Regulation - Delayed to 2019

1.  Implementation of Clinical Trial Regulation - Delayed to 2019

Posted 06-18-2017 12:52 AM

Dear Clinical Trial Disclosure Community, 

Following the European Medicines Agency's (EMA) Management Board meeting 14-15 June, EMA announced 16 June, that due to technical difficulties with the development of IT systems, the portal's 'go-live' date has to be postponed. The implementation date of the EU Clinical Trial Regulation is now 2019 instead of October 2018, as previously scheduled. 

The Agency will provide an update at the next meeting of the Management Board in October 2017 where a new delivery time frame will be discussed once progress with development has been confirmed. 

Kind regards,

 

Bob Paarlberg

Chair, CTD Community

 

 



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Robert Paarlberg
Principal
Paarlberg & Associates LLC
Canton GA
+1 (404) 345-2804
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