MHRA clarifies post-Brexit Clinical Trials Regulation

The Medicines and Healthcare Products Regulatory Agency (MHRA) has provided clarification on how the United Kingdom’s (UK’s) clinical trial rules will function in partnership with the European Union (EU) after the UK leaves the EU in March 2019.

The EU’s new Clinical Trials Regulation (CTR) is expected to be implemented during 2020 and therefore would apply to the UK under the terms of the time-limited implementation period which runs from 30th March 2019 till 31st December 2020. The new regulation will allow a streamlined application process, harmonised assessment procedure, a single portal for all EU clinical trials and simplified reporting procedures.

If the new regulation does not come into force during the implementation period, then the Government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control. For the duration of the implementation period, the UK’s access to networks, information systems and databases will continue on current terms. After the implementation period, the two main elements of the regulation 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; both require a UK/EU agreement regarding UK involvement after the implementation period.

The MHRA has stated that they cannot pre-empt the outcome of these negotiations, however the Government has preference for close cooperation with the EU across all aspects of medicines regulations.

If the UK is outside of the EU network following the end of the implementation period, the MHRA stated that “it will still be possible for sponsors to run multistate trials involving the UK. Sponsors would have to apply to MHRA, as well as to the EU concerned states; but MHRA would take every effort to ensure this parallel submission is as streamlined and efficient as possible (for example by using the same application dossier).”

It is clear that there needs to be an implementation period, however it is still subject to negotiation as to whether there will definitely be one. The future role of the MHRA, whose expertise is vital, is still being discussed.

To read more about the Clinical Trials Regulation during the Brexit implementation period, please click here.