UK Offers More No-Deal Brexit Guidance on Clinical Trials, PIPs
Posted 20 March 2019 | By
With a glimmer of hope for a short extension to the Brexit deadline of 29 March, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is still releasing guidance in case Brexit occurs without a deal in place.
On Wednesday, the MHRA published guidance on registering clinical trials, publishing trial results, future trial transparency efforts and the process for applicants applying for a Pediatric Investigation Plan (PIP), waiver, deferral or product-specific waiver. The guidance follows larger release of guidance
earlier this week.
“In the short term, you 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,” MHRA says.
Trials must be registered on a publicly accessible database within six weeks from the recruitment of the first participant, the guidance adds.
Publishing results also must be done within six months of the end of pediatric clinical trials and within one year of the end of the trial for non-pediatric trials.
“You should publish your summary results within these timeframes in the public register (or registers) where you have registered your clinical trial. You do not need to submit this clinical trial summary report to the MHRA as well; however, you must send a short confirmatory email to CT.Submission@mhra.gov.uk
once the result-related information has been uploaded to the public register,” MHRA adds.
And as far as the UK abiding by the new EU clinical trials regulation (CTR), which will not be in force by 29 March, MHRA says it “will align where possible with the CTR without delay when it does come into force in the EU.
“By the time the EU’s new portal goes live (as part of the new CTR), the UK will have its own equivalent hub that would give UK public, patients, clinicians and researchers a single reference point for all UK trials. Further guidance on this will be published in due course,” MHRA says.
In terms of the PIP application process, MHRA says it’s aiming to offer an expedited assessment where possible and to mirror the submission format and terminology of the EU's PIP system. “The scientific content and assessment required will be kept in line with European Medicines Agency (EMA) guidance documents,” MHRA says.
The UK will also follow European Commission principles established in the guideline
on the format and content of applications.
“Further step by step information on the process of submitting PIPs via the new MHRA submissions portal will be available in a user reference guide which will be published separately,” the guidance says.
Guidance on registration of clinical trials for investigational medicinal products and publication of summary results
Procedures for UK-PIPs in the event the UK leaves the EU without a deal