Euro Roundup: Advisory group urges UK to ‘rapidly explore’ recognition of US device approvals

A group formed to advise the UK government on the regulation of medical devices is pushing for officials to “rapidly explore” building an equivalence route for approvals to include jurisdictions such as the US.
 
Last year, members of the UK Life Sciences Council, which brings together government, regulators and industry, formed an advisory group to create recommendations on the reform of medtech regulation. With the UK leaving the European Union, the Council saw a “golden opportunity” and tasked the group with providing advice about international recognition, routes for innovation and system capacity.
 
Months later, the group has delivered 10 recommendations, including three that are designed to “ensure the supply of safe medical devices to UK patients is maintained through expanded recognition (e.g. to US approvals) and removing burden where possible.”
 
Building on current product recognition routes from the EU, the recommendations advise officials to “rapidly explore building a UK product regulation equivalence route for the approvals of medical devices to include other trusted jurisdictions such as the US for a greater proportion of products.”
 
As the group notes, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has already announced plans to expand recognition for medicines and create a new recognition framework by the end of the year. The group is advising the government to “aim to align changes to the Medical Devices Legislation to the Medicines legislative timeline if possible.”
 
The third supply-related recommendation is for the government to “explore greater flexibility over the requirements for physical UKCA markings on parts, instructions and labels before products can be marketed in the UK.” Related to that, the group sees value in making “greater use of registration and traceability mechanisms to ensure patient safety.”
 
All the other proposals are either designed to “help create a system wide UK integrated pathway for HealthTech, MHRA to become a more responsive regulator with supportive innovation pathways,” or to “ensure the future system is enabled, and avoids current challenges, through the development of a UK regulatory skill program.”
 
Across those proposals, the advisory group floats the idea of “expanding the role of the MHRA in the direct regulation of HealthTech, focusing initially on innovation,” creating “a robust international horizon scanning capability to proactively seek innovation” and developing “a model for expanded bespoke pre-market regulatory advice for novel/innovative products.”
 
The group recommended forming a phase two advisory group “with a focused terms of reference” to ensure momentum is maintained and the assessment of the proposals is completed by the end of April.
 
Press Release
 
Expert panel identifies ‘major concerns’ with cardiac stent after reviewing notified body report
 
A European Commission medical devices expert panel has raised “major concerns” with the evidence on a cardiac stent reviewed by a notified body (NB), leading it to recommend the indication is limited and more studies are run.
 
Following the Medical Devices Regulation process for certain high-risk technologies, the expert panel reviewed the clinical evaluation assessment report (CEAR) that the NB prepared based on the company’s submission. The report describes the evidence on an iron alloy bioabsorbable stent designed to improve lumen diameter in newborns and infants.
 
In its report, the expert panel notes that the long-term durability of the medical device is unknown and the number of patients treated is very low. The expert panel also found fault with the CEAR prepared by the NB.
 
“The NB concludes that the benefit-risk profile of the device is acceptable due to the study results in Malaysia and the adequate risk management process. This must be criticized. The indication for [right ventricular outflow tract] and [pulmonary artery] was deleted in the manufacturer’s documents, so it is unclear why the intended purpose of the CEAR is still ‘pulmonary vessels’,” the expert opinion states.
 
Expert Opinion
 
European Pharmacopoeia Commission creates working party to assess approach to excipients
 
The European Pharmacopoeia Commission (EPC) has created an Excipients Strategy Working Party (EXS). EXS will “address the specificities” of the pharmaceutical ingredients in European Pharmacopoeia (Ph. Eur.) monographs and reflect on how to further develop the excipient strategy.
 
EPC approved the creation of the working party and appointed its members last year. Now, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has provided an overview of what is expected of the experts appointed to EXS.
 
“Their first task will be to take stock of the current situation, reflect on potential areas for development and opportunities for the Ph. Eur. in the future with regard to standard setting for excipients. The aim is to make concrete recommendations to the Ph. Eur. Commission,” EDQM wrote.
 
EDQM sees the involvement of stakeholders in the process as “key to establishing a future-proof approach that takes into account the specificities of excipients compared to active substances.” Specific areas of research include setting impurity specifications, including for mutagenic impurities, and matrix effects.
 
EDQM Notice
 
EMA seeks feedback on potential primary endpoint in Duchenne muscular dystrophy trials
 
The European Medicines Agency (EMA) has released a draft qualification opinion on a potential primary endpoint for Duchenne muscular dystrophy (DMD) clinical trials for consultation.
 
In the draft opinion, EMA’s Committee for Medicinal Products for Human Use agrees that Stride velocity 95th centile (SV95C) qualifies as primary endpoint in superiority studies as an alternative to the 6 Minute Walking Test (6MWT). The acceptance of SV95C is on the condition that the primary outcome measure is supported by “consistent findings in established efficacy endpoints included as secondary endpoints.”
 
SV95C is more sensitive than the 6MWT, according to EMA, and allows continuous monitoring over long periods in a home-setting. The test could therefore address some of the variability associated with the 6MWT, the results of which can be affected by the timing of the assessment and the patient motivation at the time of the test.
 
EMA is accepting feedback until 10 April.
 
Draft Opinion
 
Number of monthly clinical trial applications uploaded to EudraCT hits new high
 
The number of clinical trial applications (CTAs) uploaded to EudraCT by member states hit a new high in January, rising by 72% month on month to reach 259. The previous monthly record, 213, was set in July.
 
EMA reported the figures in its latest set of key performance indicators for monitoring the European clinical trials environment. The data show that monthly submissions ranged from 148 to 164 over the final four months of last year, before jumping in January to a new high. In total, 2,231 CTAs had been uploaded to EudraCT by the end of January.
 
As of the most recent analysis, 793 applications have been submitted in the Clinical Trials Information System. The analyzed period covers the first year that the system was in place. Most, 629, of the filings were initial clinical trial applications. Seven of the applications made in January were resubmissions of filings that had previously lapsed, been withdrawn or not authorized.
 
EMA Report
 
Other News:
 
The European Commission has published two delegated regulations in the Official Journal of the European Union that will reduce the frequency of notified body re-assessment procedures. The move was proposed in December 2022 as part of the Commission’s effort to improve notified body capacity and is intended to enable notified bodies to focus their energy on conformity assessment procedures.
 
The Dutch Medicines Evaluation Board (MEB) tracked an increase in serious shortages last year. MEB received reports of 5,921 expected supply problems covering 2,702 different medicines, up from 3,660 reports for 1,835 medicines in 2021. No alternatives were available for six medicines. Production delays and quality control issues accounted for 55% of the problems. MEB Report (Dutch)