10
Feb
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On January 31, 2022, EU Regulation 536/2014 on clinical trials of medicinal products for human use (“Clinical Trials Regulation” or “CTR”) finally went into effect more than seven years after its approval, but Italy is not yet ready for its application.
This process has taken a long time (much longer than expected) due to the need to develop a complex IT architecture, i.e., a European portal for the...