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The EU Regulation 536/2014 for clinical trials of medicinal products is in effect throughout Europe since 31 January 2022. From 01 February 2023, clinical trials must be submitted for approval via the electronic EU portal in accordance with the CTR. This means that the transition period (since 01 February 2022), during which clinical trials could be submitted according to the previous or new standard, will terminate at the end of January 2023. With the start of the transition period since February 2022, authorities and sponsors have the opportunity to make preparations, identify system errors and work out solutions. All parties involved wish for a smooth implementation. The pharmaceutical industry and Clinical Research Organisations (CROs) in particular the Charité Research Organisation GmbH are well prepared, small companies and start-ups may seek the support of experienced CROs.

This white paper provides an insight into the main changes introduced by the regulation and an insight into the ongoing preparations of all stakeholders, the associated new challenges and planning strategies.