10/11 October 2023
The British Government has published first notices in the event that the UK leaves the EU without agreement (so-called "hard Brexit"). These notices also concern clinical trials. With the Brexit, the British regulatory authority (MHRA) will loose the connection to several central communication portals by which pharmaceutical companies and authorities can transmit data to the European Member States. This includes common systems like EudraCT and the new CTR (Clinical Trial Regulation) Portal.
In case of a "hard Brexit", it will no longer be possible to submit data via the central EU portals to the MHRA. Therefore, information will have to be transmitted to the UK authority directly. For this purpose, individual national UK-portals will have to be programmed until the Brexit. According to this, as of 29 March 2019 information to be transmitted among the EU and to the UK will have to be submitted separately via the EU systems and the national MHRA-portals (if necessary, using different technical standards). However, the EU application forms and the standards laid down in the EU will be provisionally accepted for the transmission of data. Further information regarding the general transmission to the national UK portals is announced to be released until the Brexit.
The new EU GCP Regulation (Clinical Trials Regulation 536/2014, CTR) which redefines the future requirements regarding clinical studies in the European Union came into force in 2014. Because of extensive and long-standing transitional provisions, the CTR (including all pending documents like for example the Detailed Commission Guidelines on GMP for IMPs in Annex 13 of the EU GMP Guide) is not applicable yet. The requirements laid down in the GCP Directive 2001/20/EU still apply in the EU and have also been incorporated into national UK law. In the event of a "hard Brexit", the new CTR will not be incorporated into UK law as it hadn't been applicable in the EU at the time that the UK exits the EU. As a result, UK will first hang on to the already implemented requirements according to the 2001/20 directive. However, an alignment ("where possible") with the CTR, which would be subject to usual parliamentary approvals, should take place without delay as soon as the CTR comes into force in the EU Member States.
With regard to clinical trial applications, UK will still apply the current national practice (authorization by the MHRA and ethics committees). British centres will continue in participating in multinational trials. Furthermore, it has been announced that the MHRA will be improving processes to enable closer working with ethics bodies and allowing national applications and national decisions regarding clinical trials in the UK. For this purpose, a pilot project has already been started.
Legal presence: Currently, the sponsor or his/her "legal representative", should be based in the EU or in a country of the European Economic Area (EEA). According to the announcement this position would be maintained in case of a "hard Brexit". However, in future, the UK will require - as long as British centres are involved - to have an individual based in the UK who has overall responsibility for the trial. This person will be contacted to discuss urgent issues regarding the trial, e.g. necessary safety matters or trial suspensions. More information on this topic will be announced as well as further information on the alignment of UK transparency provisions with those currently operating in the EU.