EU Sees Sharp Rise In Clinical Trial Applications Via New Portal
Notably more clinical trial applications were submitted to the new Clinical Trial Information System in July compared with previous months, according to new data that also shed light on how many submissions have been approved or rejected.
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At a recent webinar on the EU Clinical Trial Information System (CTIS), representatives from different EU member states said the new system was working well and highlighted certain “good practices” for study sponsors to consider.
The EU’s new trial portal and database system, which allows the submission of a single application to conduct a study across any number of EU countries, has yielded its first fruit in the form of an approval for a non-commercial Swedish clinical trial involving cardiac arrest patients.
The product information for all pseudoephedrine-containing medicines in the EU will need to be updated, the European Medicines Agency said today.