Clinical trial submission process in Europe headed for change

4 May 2023

european_union_commission_brussels_large

The European Medicines Agency (EMA) is considering changing the transparency rules around clinical trials, with a public consultation on the matter now open.

The EMA is looking to revise the rules around submissions to the Clinical Trials Information System (CTIS), with the goal of finding the right balance between transparency and confidentiality.

At the same time, the EMA wants to simplify the system to improve user experience and reduce the risk of data breaches.

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