How the UK proposes to regulate clinical trials in case of a ‘no-deal’ Brexit: Updated guidance released
The guidance note also applies to the regulation of medicines and medical devices and follows a series of technical notices published last summer.
The document details the potential results in the event that a deal is not made during ongoing Brexit negotiations, though the BBC today reported that Members of Parliament (MPs) will vote on UK Prime Minister Theresa May’s Brexit deal on January 15th.
In the case of no deal, the MHRA would take on responsibilities currently undertaken through the EU system.
“We [MHRA] aim to give businesses and individuals as much certainty as possible as soon as we can, and to ensure that any new requirements are not unduly burdensome,” the guidance reads.
Updated and more comprehensive, the guidance includes changes following the Medicines and Healthcare products Regulatory Agency (MHRA)’s consultation in October.
The guidance note updated January 4th proposes the UK system would operate as follows:
Existing approvals
The UK will continue to recognize existing approvals – both for regulatory and ethics approvals – and there will be no need to re-apply, according to the MHRA.
Trial sponsor location
The government previously proposed the introduction of a UK contact point in case of a no deal, though following stakeholder feedback, it has concluded that separate registration of a UK contact point “is not considered necessary.”
“…We recognize that if the UK needs to suspend or terminate a trial, the current legislation allows the MHRA to serve the suspension/termination notice on the sponsor or the investigator(s) who are responsible for the conduct of the trial at the relevant UK sites,” according to the guidance.
Still, per EU requirements, trials outside of the EU must have EU-based sponsors or legal representatives.
Regulatory requirements for running trials
The UK’s current regulatory framework will remain in place but will be modified under the EU Withdrawal Act (EUWA).
“The new EU Clinical Trials Regulation (CTR) 536/2014 will not be in force in the EU at the time that the UK exits the EU and so will not be incorporated into UK law on exit day,” according to the guidance, though the UK last year voiced its commitment to post-Brexit clinical trial rule harmonization.
The guidance explained, "in the event of no-deal the Government will re-align with the parts of the EU’s CTR legislation that are within the UK’s control.”
IMP testing and certification
For investigational medicinal product (IMP) coming into the UK, the country will recognize qualified person (QP) certification conducted in an approved country, which initially includes all EU and European Economic Area (EEA) countries.
“This means that stakeholders will not need to QP certify IMP in the UK, if it has already been certified in one of the countries on the approved country list,” the guidance explained.
The EU currently requires IMP testing to be conducted within the EU/EEA.
Import licensing
According to the MHRA, a manufacturers license (MIA) will be required for all importers of IMPs into the UK. Additionally, the IMP supply chain from EEA states will allow direct supply to clinical investigator sites.
“For IMPs coming from countries on the approved country list the MIA(IMP) holder will be required to put in place an assurance system to check these IMPs have been QP certified in the EU or EEA,” the notice explained – and this system must be overseen by a QP, though these IMPs would not require re-certification.
“IMPs coming from other countries would, as today, require QP certification in the UK by the MIA(IMP) holder. Third party MIA(IMP) holders already exist, who act as the importer for IMPs from existing third countries to UK Clinical Trials site,” per the guidance.
Sponsors will have 12 months after the UK’s exit from the EU Exit to comply. Additional guidance will be published before this time.
Safety reporting
The UK currently requires sponsors to submit all suspected unexpected serious adverse reactions (SUSAR) reports to the MHRA, and will continue to do so in the future via UK-based systems.
Annual safety reports for all UK trials must still be submitted to the MHRA.
Clinical trial applications
UK clinical trial applications will continue to be authorized by the MHRA and ethics committees, and the country’s participation in multinational trials will not change, according to the update.
“Looking beyond the immediate term, the MHRA will be improving processes for clinical trials to enable closer working with ethics bodies and allowing a single application and a single national decision in the UK,” according to the guidance.
Initial pilot work is underway and will continue to develop following the exit.
Publishing trial results
Sponsors should continue using registries such as EudraCT (EU), ISRCTN (International Standard Randomized Controlled Trial Number) registry, ISRCTN (UK), and ClinicalTrials.gov (USA).
According to the guidance, “The UK’s overall intention is to align transparency provisions with those currently operating in the EU, in order to eliminate the need for companies to duplicate efforts.”
Patients and clinicians will have access to information about clinical trials via the UK Clinical Trials Gateway.
As part of the new CTR, the EU is introducing a new portal, though the guidance noted the UK also will have its own hub at the time of launch.
For more information, view the complete guidance note here.
