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New implementation date of the Clinical trial regulation

The European Medicines Agency (EMA) has just announced that the implementation date of the EU Regulation governing clinical trials (CTR) and the go-live of the centralised portal is scheduled for December 2021.

The regulatory audit to check the IT system (CTIS) is planned to start in 6 months, in December 2020. Concretely, sponsors, either commercial or academic, must wait an additional 18 months to use CTIS and run their clinical trials on medicines throughout the EU with the same application file. Procedures, ICF and contracts should thus be adapted.

A launch in December 2021 would mean that it has taken seven years since the publication of the CTR. Amongst others, Brexit, with the EMA move to Amsterdam, and Covid-19, have been the last obstacles delaying the implementation of the regulation and the new system. 


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