Euro Roundup: UK seeks feedback on ending EU reliance pathway, switching to international recognition in 2024
The Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation into plans to end the option to bring medicines to market based on decisions by the European Commission. MHRA published the consultation alongside guidance on its new international recognition procedure.Seeking to minimize the disruption of Brexit, MHRA has enabled companies to bring medicines to the UK market via the European Commission Decision Reliance Procedure (ECDRP). The procedure allows MHRA to rely on a Commission decision to approve a medicine in the UK without any further consideration, but the agency plans to abandon the pathway at the end of the year.
“Whilst the ECDRP provided market stability following UK’s exit from the EU, we are now in a position to implement a more considered approach to our assessments and accept applications from a wider range of partners,” MHRA wrote.
In the guidance, MHRA outlines how the ECDRP has worked in practice, explaining that, while in theory, it can rely solely on a Commission decision, the agency has “found it needs to undertake limited assessment of scientific data in the majority of cases to be assured that there are no benefit-risk or health issues.” The agency plans to amend the Human Medicines Regulations 2012 to remove the ECDRP procedure.
Ahead of the planned termination of the pathway on 31 December, MHRA has asked stakeholders if they support the proposal to stop using the ECDRP. The consultation also asks whether the proposal “could impact people differently with reference to their protected characteristics” such as age, race and disability under equality law. MHRA does not think the change risks “impacting people differently.”
If MHRA drops the ECDRP as planned, it will replace the EU-focused pathway with a new international recognition framework. The new framework will join the ACCESS Consortium, Project Orbis and the Mutual Recognition Decentralised Reliance Procedure as one of four routes to the UK market that feature reliance procedures.
The international recognition framework is outside of the scope of the consultation, but MHRA published guidance on the incoming pathway alongside its request for feedback on the elimination of the ECDRP. In the guidance, MHRA explained the scope of the framework, which covers new treatments, off-patent medicines, hybrid applications and fixed-dose combinations, and the process for seeking authorization.
If the reference regulator has approved a product within the previous two years, MHRA will review an initial marketing authorization application “to a 60-day timetable from validation, with no clock stop.” The agency took up to 67 days to assess applications under the ECDRP. The pathway is also open to drugs approved in the previous 10 years, but MHRA will apply a longer, 110-day timetable to those products.
The longer timetable applies to some recently approved medicines too. MHRA will take up to 110 days if pivotal clinical data are from single-arm studies, real-world data is central to the submission, the product contains a first-in-class new active substance and if various other factors that necessitate a longer review are present. The timeframe is still shorter than the national 210-day review deadline.
Across the rest of the guidance, MHRA walks through the application process, how to handle details such as pediatric requirements and risk management plans, the documents required from different reference regulators and active substance master files. MHRA is set to start using the procedure on 1 January.
MHRA Consultation, MHRA Guidance
MHRA publishes nitrosamine impurity guidance
MHRA has published guidance on nitrosamine impurities in medicines, covering topics such as common submission mistakes and other information to help manufacturers adhere to safe levels of the impurities.
In the guidance, MHRA explains that it looks to align nitrosamine-related regulations with international authorities while ensuring the appropriate application in the UK. That approach has led the agency to adopt a harmonized approach to acceptable intake levels based on ICH M7 guidelines and to review the EU’s decisions on the impurities. In some cases, MHRA recognizes EU assessments.
MHRA aims to maintain consistency with the European Medicines Agency (EMA) “considering historical ties” but will diverge if needed. When MHRA’s assessment differs from EMA publications, it sends its conclusions directly to the affected marketing authorization holders.
One part of the guidance lists 11 mistakes that MHRA frequently encounters in nitrosamine submissions, including a lack of initial submission details, inadequate sensitivity of analytical methods and incomplete risk evaluation and assessment. Other sections of the document address releasing batches with levels of the impurities above the acceptable limit and the temporary use of the less-than-lifetime concept.
MHRA Guidance
EMA backs approval of Pfizer’s updated COVID vaccine; Swissmedic assesses Novavax filing
EMA has recommended Pfizer’s adapted Comirnaty vaccine targeting the omicron XBB.1.5 subvariant for authorization. The EMA recommendation coincided with news that Swiss authorities are reviewing a filing for approval of Novavax’s XBB 1.5 vaccine.
Earlier this year, EMA, following the international consensus, recommended updating vaccines to target XBB strains, a subgroup of omicron. The agency added that monovalent vaccines, such as products that only target XBB 1.5, “are a reasonable choice to provide protection against current dominant and emerging strains.”
EMA based its Comirnaty decision on lab data showing the vaccine’s effect against XBB 1.5, plus clinical data on other versions of the vaccine.
The Swiss Agency for Therapeutic Products (Swissmedic) noted that it has received an application for authorization of Novavax’s Nuvaxovid XBB.1.5. Future Health Pharma, which represents Novavax in Switzerland, has filed for approval of a version of the protein-based vaccine that contains a non-infectious component from the surface of SARS-CoV-2 omicron subvariant XBB 1.5.
EMA Notice, Swissmedic Notice
MHRA designates three UK-approved bodies, boosting medical device certification capacity
MHRA has designated three UK-approved bodies to certify medical devices, increasing the total number to seven.
UK law requires manufacturers of most medical devices, the exception being the lowest-risk products, to apply to an approved body for UKCA certification, just as they work with notified bodies to get CE marks to sell products in the EU. Until this week, the UK had four approved bodies, BSI, DEKRA, SGS and UL. The existing designations covered a mix of medical device and in vitro diagnostic (IVD) certifications.
TÜV SÜD, Intertek and TÜV Rheinland now have joined the ranks. All three approved bodies are designated to certify general medical devices. Only TÜV Rheinland has the power to certify IVDs.
“By almost doubling capacity for medical device assessment in the UK, we’re supporting patients to access the safe and effective products they need to protect their health,” Laura Squire, chief healthcare quality and access officer at MHRA, said in a statement.
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