The Medicines and Healthcare Products Regulatory Agency (MHRA) has released guidance about registering clinical trials, publishing trial results and future requirements if the United Kingdom (UK) leaves the European Union (EU) without a deal. The guidance will apply from exit day subject to the Human Medicines Regulations (Amendment etc.) (EU Exit) Regulations 2019 being passed. The guidance will only apply in the event of ‘no-deal’ scenario.
The UK plans to align transparency provisions with those that currently operate in the EU to help ensure that companies do not need to duplicate efforts. The MHRA have stated that companies should continue to use existing and established international registers such as EudraCT (EU), ISRCTN (International Standard Randomised Controlled Trial Number) register (UK), and ClinicalTrials.gov (USA) to ensure that UK patients are aware of your trial.
Any approval by a research ethics committee in the UK is subject to the condition that all clinical trials must be registered on a publicly accessible database. This must be carried out within 6 weeks from when the first participant is recruited. In accordance with current transparency rules operating in the EU, a sponsor may request a deferral for study registration within the required timeline, however they should contact email@example.com.
Summary of results should be posted within 6 months of the end of the trial for paediatric clinical trials or within one year of the end of the trial for non-paediatric clinical trials.
Under the new EU Clinical Trials Regulation (CTR) 536/2014, transparency measures will be strengthened. If the UK leaves the EU on 29th March 2019 with no deal, the Regulation will not yet be in force in the EU and thus will not be incorporated into UK law on exit day under the current terms of the EU Withdrawal Act. Although, the MHRA and UK plans to align where possible with the CTR without delay when the new Regulation does come into force in the EU, subject to normal parliamentary approvals.
By the time the EU’s new portal goes live as part of the new CTR, the MHRA have stated that the UK will have their own equivalent hub that would allow for a single reference point for all UK trials for the UK public, patients, clinicians and researchers.
To read the MHRA’s guidance on registration of clinical trials for investigational medicinal products and publication of summary results, please click here.