10/11 October 2023
The EU Clinical Trials Regulation 534/2014 (CTR) entered into force in 2014 but will not apply until 6 months after the European Commission issues a statement of the full functionality of the new EU clinical trials portal and the corresponding database. The new portal and database, which all member states can access, will avoid duplication of work, and hopefully, save time and money. It is expected that this will speed up registration of trial results and the marketing and licensing of new drugs within the EU. However, the development of the portal and the database is taking longer than anticipated. Therefore, other than previously announced (it was expected for March 2019) it is now likely that the CTR will not be implemented until March 2020. Due to this delay in getting the portal and database ready to work, the CTR will not come into force until after the UK has left the EU in March 2019 and, thus, will not be incorporated into UK law.
Currently, according to the Clinical Trials Directive, the sponsor has to submit separate clinical trial applications for a multinational study to the authorities and ethics committees of each EU member state involved. Multiple applications and authorizations are required when a trial is conducted in multiple member states (or in multiple countries). The CTR harmonizes the rules for conducting clinical trials throughout the EU and streamlines the application process. The new EU clinical trial portal will enable sponsors involving multiple sites to submit a single application to the authorities of all EU Member States concerned. Hence, applications will initially be assessed by a single reporting EU Member State and then be validated by the remaining concerned Member States and undergo national ethics reviews. The new procedure is expected to accelerate the authorization procedure for conducting trials in the EU.
The UK Government recently confirmed that the Government is committed to implementing the EU CTR into UK law to the extent possible. The participation in the database and portal beyond the transition period will require agreement with the EU as part of the wider Brexit negotiations. The EU and UK should then be able to continue to collaborate and work together effectively after Brexit. This also ensures that patients will gain access to trial medicines without delay.
In line with the Government’s position, the UK Medicines and Healthcare products Agency (MHRA) recently published its Five Year Plan for 2018-2023, which refers to MHRA’s progress in working towards implementation of the CTR, "so that the UK continues to be an excellent place to do research".