UK Avoids 'Cliff Edge' By Extending EU Drug Approval Reliance Procedure
Executive Summary
The UK drugs regulator says it needs to make sure that companies do not “deprioritize” GB approval applications while a new “international reliance framework” is being developed.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has extended by one year the streamlined procedure that allows pharmaceutical companies to gain faster Great Britain marketing authorizations based on approval recommendations made by the European Medicines Agency.
The European Commission Decision Reliance Procedure (ECDRP) was introduced in response to concerns that after Brexit, companies might delay new drug submissions to the MHRA in favor of an EU filing that can produce a single approval valid in 27 member states.
The scheme was due to expire at the end of 2022, but it will now last until 31 December 2023, in order to “ensure British people continue to have timely access to medicines while MHRA develop proposals for a new international reliance framework,” the MHRA declared.
The UK BioIndustry Association welcomed the move. “The removal of the cliff edge in December will benefit both UK patients and life sciences companies and allow continued timely access to new, innovative medicines,” it told the Pink Sheet.
The Association of the British Pharmaceutical Industry also praised the extension, saying it was something it had advocated for. “The extension means that patients will get timely access to medicines, and for companies it means that any medicine already granted approval by the European Medicines Agency can be submitted to the MHRA , to be considered for licence with a lighter touch review," said the ABPI's director of quality, regulatory science and safety policy, Steve Hoare.
The ECDRP, which came into effect on 1 January 2021 at the end of the Brexit transition period, was specifically designed for products that are filed with the EMA through the centralized approvals procedure.
It allows the MHRA to approve a drug based on a positive opinion issued by the EMA’s human drugs committee, the CHMP – the company sends the MHRA the CHMP’s assessment of the marketing authorization application. The MHRA can then issue an approval decision within 67 days (the same time the commission has to make a decision on marketing authorization following the CHMP opinion).
The MHRA approval is only valid in Great Britain, as Northern Ireland is still part of the EU medicines regulatory network, as per the Northern Ireland protocol.
The MHRA described the one-year extension of the ECDRP as an “essential mitigation” that would reduce the risk of companies “deprioritizing GB for medicines authorization” and ensure patients continued to have timely access to “the latest innovative medicines that meet high standards of safety.”
It added that the launch of new medicines had “long lead times and regulatory strategies” that are “planned months or years in advance.” Extending the ECDRP, it said, would “provide a suitable timeframe for the right strategies to be developed that capitalize on the opportunities of being a sovereign regulator.”
New International Reliance Framework
Asked about the proposed international reliance framework and which other countries would be involved, an MHRA spokesman said: “We have already started working with stakeholders to build the proposals for this new strategy and will provide further details in due course.”
The MHRA is already part of two international collaborative programs – the Access Consortium and Project Orbis – and it remains to be seen whether the new framework will involve regulators from these two initiatives – or indeed the EU regulator.
“A new international reliance framework is still needed, to minimize duplication in the regulatory review process and bring innovative treatments to patients with minimal delays across nations,” the ABPI's Hoare commented.
The BIA said it looked forward to continuing the “positive dialogue and engagement with MHRA to develop proposals for a new international reliance framework which will replace the ECDRP from January 2024.”
It also noted that the BIA's reflection paper on the role and value of reliance in the UK medicines regulatory framework, published in June, would make “a useful contribution to our discussions.”
Reliance-based regulatory procedures can be used across all stages of the product lifecycle, the BIA pointed out. “The COVID-19 pandemic has stressed the importance of reliance to address the significant workloads of regulators as well as the urgent need to deliver new and established treatments for patients globally,” it added.
The ECDRP Process
Under the ECDRP, the company sends the MHRA the full marketing application as reviewed by the CHMP, together with the applicant’s responses to questions from the committee and the various versions of the assessment report.
Companies are encouraged to make the GB submission within five days of the CHMP positive opinion, in which case the 67-day assessment time will be calculated from the date of that opinion. If the submission is made more than five days after the opinion, the assessment period will begin from the time the MHRA application is validated.
This article was updated on 4 October with comments from the ABPI.