The UK will Follow the EU Clinical Trials Regulation (CTR)
Aptus Clinical are delighted at the MHRAs announcement this week that the UK will follow the EU Clinical Trials Regulation (CTR) when it is implemented in 2020. This provides much needed reassurance for us and our clients.
The announcement has confirmed the continued regulatory access arrangements for the UK following its departure from the EU in March 2019, until December 2020. Thereafter, the UK has repeated its commitment to retaining ‘as close as possible alignment with EU regulations”.
The adoption and implementation of CTR is significant as it will provide a streamlined application process, harmonised assessment procedures, a single portal for all EU clinical trials and simplified reporting processes, including for multi-member state trials.
This is great news for Aptus Clinical and any biotechnology company wanting to have uninterrupted access to the world class investigational sites and other significant benefits offered by the UK.
The full announcement from the MHRA can be read here, but key points are:
- UK and EU have agreed the terms of an implementation period from 30 March 2019 to 31 December 2020. During this time, the UK will no longer be a Member State of the European Union, but market access will continue on current terms
- CTR is expected to be implemented during 2020 and will apply to the UK under the terms of the implementation period
- If the new regulation is not enforced during the implementation period, UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control. The two key elements that the UK would not be able to implement on its own are the use of a shared central IT portal and participation in the single assessment model
- Regardless of the outcome of negotiations, the UK is committed through its Life Science Industrial Strategy to increasing the number of clinical trials and creating a favourable environment for research and development
- If the UK is outside of the EU network following the end of the implementation period, sponsors would have to apply to MHRA, as well as to the EU concerned states; but MHRA would work to ensure this parallel submission is as streamlined and efficient as possible
- The current regulatory approval legislation will stay in place until any changes are needed, so there will be no interruption in UK clinical trials approval
We shall continue to closely monitor the situation as negotiations progress and will adjust our robust clinical activity planning with our clients accordingly. We are nevertheless confident that a post-Brexit UK will continue to be a highly attractive place to conduct clinical research and will remain a key global player in transforming promising molecules and therapies into valued treatments.
Glen Clack MB, BS, MD, FFPM
Chief Medical Officer
Head of Clinical Services