UK Government has issued new Brexit guidance for the life sciences sector. With the transition period coming to an end on 31 December, only three months remain before the Medicines and Healthcare products Regulatory Agency (MHRA) takes on its role as the UK’s standalone medicines and medical devices regulator.
In this article, we look at the registration and publication rules around clinical trials of medicinal products.
As many aspects of clinical trials regulation are still under national control, the changes in this area are less substantial than in some other areas of activity. But there are several important changes to note.
Registration of clinical trials
The application process will be through the Integrated Research Application System (IRAS), as now.
The guidance notes that applicants for ethics committee approval must normally provide details of the registration of the clinical trial on a publicly accessible database, such as ISRCTN registry (UK), or ClinicalTrials.gov (USA).
Where there is commercial sensitivity, it may be possible to defer study registration. This must be discussed in advance with the Health Research Authority.
Publication of clinical trial results
The clinical trial results should be published within the required time frames – one year, or six months for paediatric clinical trials. Publication of the clinical trial summary results should be in the public register where the clinical trial is registered. A confirmatory email, with a link to these results, should be submitted to the MHRA and a final report to the Health Research Authority.
The EU Clinical Trials Regulation
The EU’s revised law on clinical trials (Regulation (EU No 536/2014)) will not be in force before the end of 2020, and so will automatically be reproduced as part of UK law. Existing UK legislation based on the EU Clinical Trials Directive (Directive 2001/20/EC) will remain in place for now. So far it is not clear which elements of this the UK will seek to replicate.
EU clinical trials
For trials carried out in the EU, UK sponsors will need an EU legal representative. The UK will be considered to be a third country for the purposes of importing investigational medicinal products. An EU Qualified Person will be required for checking IMP batches. Further guidance on these requirements is available here.
Finally, subject to a further agreement being reached between the UK and the EU which addresses some of the issues around the Northern Ireland market, rules in Northern Ireland will differ from the rest of the UK. Separate analysis is likely to be required here.