It has been a while, but the EU Clinical Trials Information System (CTIS) is set to go live on 31 January 2022. This means that the system set up in 2014 under the Clinical Trials Regulation will finally come into effect.
The European Medicines Agency has published a set of training and information resources to assist users to prepare, including a detailed Sponsor Handbook.
A three year transition period will allow sponsors of EU clinical research time to transfer to using the new system, although EU member states are expected to start using it from the go-live date. Sponsors will be able to choose whether to submit a new clinical trial application under the existing Clinical Trial Directive (2001/20/EC) or the Clinical Trials Regulation until 31 January 2023. All clinical trials that are still ongoing must be transferred to CTIS by 31 January 2025.
The UK is not directly affected by this change, although the Medicines and Medical Devices Act 2021 allows for the updating of UK clinical trials legislation away from the existing approach. The recently published Life Sciences Vision recommends using this power to cut red tape and promote innovation and efficiency:
“In line with the recommendation of the Taskforce for Innovation, Growth and Regulatory Reform (TIGRR), use the recently passed Medicines and Medical Devices Act 2021 to radically improve existing legislation on clinical trials, so that it is no longer reflects the EU’s Clinical Trial Directive.”
This article was written by Medilink Midlands Patron, Mills and Reeve LLP.
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