Euro Roundup: EMA group recommends actions to accelerate regulatory science research

A European Medicines Agency (EMA) group has recommended actions the regulator and industry can take to accelerate regulatory science research.

EMA’s Focus Group on Regulatory Science Research Translation spoke to academic and industry groups in public-private partnerships to learn priorities and approaches for precompetitive research consortia. The conversations, which were part of the group’s work to ensure regulatory science research outputs are accepted and used, informed recommendations to help projects deliver practical applications.

The group recommended that EMA expand its capacity for evaluating and supporting relevant externally funded projects and develop “a framework for formalized and publicized regulatory reflections” on such initiatives and their outputs. EMA should also use the European Platform for Regulatory Science Research to support understanding of needs and how to meet them, the group said.

Other recommendations include exploring how to increase the visibility of regulator-supported consortia outputs. The group wants EMA to consider how to make the research outputs more visible in regulatory procedures, discussions, and public-facing documents, and how to track the use of regulator-accepted outputs in marketing authorization applications.

The group made other recommendations to industry and academics, plus suggestions applicable to all stakeholders. Industry participants in precompetitive projects and consortia should provide regulatory strategic advice and intelligence proactively, the group said. The goal is to ensure all partners expand their understanding of regulatory pathways and gain knowledge that benefits future projects.

Other recommendations for industry include supporting training of academic collaborators, aligning with partners on expectations for regulatory acceptability and evidence requirements, and promoting sharing of deliverables.

The group also discussed priorities and approaches for consortia to accelerate the translation of research outputs. The priorities address regulatory preparedness, project deliverables, and regulatory awareness and engagement. The group has shared advice on how people involved in precompetitive collaborative projects or consortia can start and continue engaging regulators.

Output Report

EDQM seeks feedback on bacterial endotoxin guidelines, draft monographs

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has released guidelines for bacterial endotoxin testing and draft monographs for consultation.

EDQM is seeking feedback on the documents until 30 June. The guidelines cover using the bacterial endotoxin test described in another general chapter. Officials have proposed adding a test method using recombinant factor C (rFC) and clarifying which provisions only apply to amebocyte lysate. Other changes include the reinstatement of a section on replacing methods prescribed in a monograph.

As part of the reinstatement, officials have added a reference to the rFC method. Authorities in Europe and other parts of the world have supported rFC to provide an alternative to classic lysate-based tests, which rely on materials obtained from horseshoe crabs. Concerns about the sustainability of harvesting the crabs and the variability of the animal-derived reagents have fueled interest in alternatives.

EDQM released draft monographs for consultation alongside the bacterial endotoxin guidelines. The directorate is seeking feedback on more than 20 draft monographs for molecules including oseltamivir, an antiviral sold as Tamiflu, and the statin fluvastatin. The monographs will be legally binding once adopted, leading EDQM to tell manufacturers it is extremely important to share feedback on the drafts.

EDQM Notice, More

EC updates advice on assessing risk of device disruptions harming patients

The European Commission has updated its guidance on evaluating whether medical device disruptions need reporting because of the threat to patients or public health.

Europe’s medtech regulations require companies to report device and diagnostic supply interruptions or discontinuations if the disruption could cause serious harm or a risk of serious harm to patients or public health. Manufacturers are responsible for determining whether harm is reasonably foreseeable. The Commission published a guide in 2024 to inform manufacturers’ assessments of the potential for harm.

As part of its second update to the document, the Commission has published a decision tree diagram that poses a series of questions to help manufacturers assess whether they need to notify authorities about a supply disruption.

Many paths through the decision tree lead to the conclusion that no notification is required, although in those outcomes the Commission still recommends considering notifying healthcare institutions and providers about the issue. No notification is needed if known stock levels can meet demand until supply resumes or an alternative device is available.

Notifications are needed when the supply disruption could result in an imminent risk of death, a serious deterioration of health, or a life-threatening condition, and no existing products or alternative devices are available to prevent those outcomes.

Updated Q&A, Decision Tree

MHRA receives £3.6M to expand regulatory sandbox for AI medical devices

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has secured £3.6 million ($4.9 million) to expand its AI Airlock program.

Through the program, MHRA has established a regulatory sandbox for artificial intelligence as a medical device (AIaMD). The sandbox, which the agency began piloting in 2024, is intended to improve understanding of the regulatory challenges associated with using AIaMD in healthcare settings. Working with partners, the agency has evaluated real AIaMD products in supervised, simulated environments.

Having completed phase two of the project, MHRA has received Department of Health and Social Care funding through 2029. MHRA said the multi-year funding will enable it to scale AI Airlock beyond the constraints of annual financial cycles, supporting more ambitious, longer-term testing models.

The agency plans to publish reports from phase two in the summer. MHRA will use the reports, plus the findings of its earlier pilot project, to inform the design of phase three and its broader approach to AI regulation. The agency expects to share details of phase three and issue a call for applications this year.

Press Release

MedTech Europe flags potential for USTR investigations to hit medtech industry

MedTech Europe has advised medical device manufacturers to review Office of the United States Trade Representative (USTR) investigations that could affect their operations.

The trade group highlighted USTR investigations into “structural excess” production capacity and forced labor. USTR identified Germany and Ireland as economies running significant trade surpluses in specific sectors and included the EU, Norway, Switzerland, and the UK in its review of potential failures to act on forced labor.

Neither investigation explicitly references medical technology. However, MedTech Europe said outcomes of the reviews could affect European manufacturers exporting to the US. Because medtech supply chains are globally integrated, MedTech Europe warned any trade measures implemented as a result of the two investigations “could affect market access conditions and trade flows.”

That prospect led the trade group to encourage its members to review the investigations and consider responding to the public consultations, which will inform USTR’s rulings about whether trade measures are needed. USTR is accepting responses until 15 April.

Press Release

Other News:

MHRA is stepping up its collaboration with the US Food and Drug Administration to accelerate access to medical devices. The UK agency said it will work with its US counterpart to improve and align regulations, including through mutual recognition mechanisms, reduced duplication for companies, and streamlined approval processes. MHRA Notice

MedTech Europe hailed progress on the EU-Mercosur Partnership Agreement as beneficial for medical device companies targeting countries including Argentina and Brazil. The deal will lower tariffs and make public procurement more transparent. Press Release