EMA Confirms CTIS Ready For Mandatory Use By 31 January Deadline
The European Medicines Agency says that over 80% of the blocking issues and related workarounds affecting the Clinical Trials Information System have been resolved.
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EFPIA acknowledges that while the mandatory use of the EU Clinical Trials Information System from today is a significant milestone, it says the usability and functionality of the system need to be enhanced and there are also issues with the Clinical Trials Regulation that need to be fixed.
Just a day before it became mandatory to use the single-portal Clinical Trial Information System, the European Commission published concise advice for sponsors and investigators who want to conduct trials in Europe.
A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.