Post-brexit clinical trials rules explained

The MHRA has explained how clinical trials rules will work in partnership with the EU after Brexit. A representative of the MHRA said: “As part of exit negotiations, MHRA is working to ensure that we continue to have the best possible environment in which to support clinical trials. Our overall aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines. The new regulation is a major step forward. It will enable a streamlined application process, harmonised assessment procedure, a single portal for all EU clinical trials and simplified reporting procedures, including for multi-Member State trials. The UK was involved in developing the new regulation that has been widely welcomed by Europe’s research sector, including academia, medical research charities and industry. We cannot pre-empt the outcome of these negotiations, but the government has always been clear on its 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, 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).”
Deputy Chief Scientific Officer for the ABP, Dr Sheuli Porkess, said: “Pharmaceutical companies need as much clarity as possible so they can continue to supply medicines to patients as the UK leaves the EU. Today’s guidance from Government is welcome, as is the reiteration of the UK’s preference for close cooperation with the EU across all aspects of medicines regulation. There are still some unanswered questions. We are clear that there needs to be an implementation period but whether there will be one is still subject to negotiation. The document also states that the future role of the MHRA, whose expertise is vital, is also still being discussed. The industry will continue to plan for all scenarios, including ‘no deal’. We believe that the best way to protect patients and public health is for the EU and UK to agree continued cooperation on the regulation of medicines.”