In the past, sponsors had to submit clinical trial applications separately to national competent authorities (NCAs) and ethics committees in each European country to gain regulatory approval. To run a clinical trial, and registration and posting of results were also separate processes. With the new Clinical Trials Information System /CTIS), sponsors can now apply for authorisations in up to 30 EU/EEA countries at the same time and with the same documentation. Publication of the trial information is built in the system. This should strengthen Europe’s position as an attractive location for clinical research and enhance transparency on outcomes of authorised clinical trials.It also has an impact on Annex 13 of the EU GMP Guide, which will be replaced by the new regulation.
What’s the timeline?
Along with this EMA has published a comprehensive Q&A on the new regulation, as well as various descriptive material and You Tube videos on the subject.
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