Euro Roundup: MHRA launches AI Airlock

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched AI Airlock, a new regulatory sandbox designed to help understand risks related to AI as a Medical Device (AIaMD).

MHRA outlined plans to create AI Airlock in October and included the sandbox in a paper on its AI policy last month (RELATED: UK regulators to create a ‘sandbox’ for AI development, Regulatory Focus, 02 November 2023). MHRA plans to include four to six virtual or real-world projects in the pilot project to test a range of regulatory issues when devices are used for direct clinical purposes in the healthcare service.

“The objective of AI Airlock is to identify regulatory challenges to AIaMD and work collaboratively to understand and potentially mitigate any risks that are uncovered,” MHRA said. “Relevant stakeholders and the product providers will be able to use the AI Airlock product reports to share knowledge and findings to assist with further funding or assessment activities.”

Guarantee of regulatory conformity is not the objective of this project, MHRA said, but involvement “will benefit manufacturers on their regulatory journey.” MHRA said the AI Airlock could help detect and report product performance errors, including drift and failure modes in postmarket surveillance data. Other potential outcomes include producing pre-market evidence of safety and “breaking down the complexities of generative AI-based medical devices.”

The agency plans to accept applications after hosting a webinar on 5 June. MHRA wants to focus the pilot on a few products that cover a range of regulatory issues, clinical disciplines, and regulatory maturity levels. The agency explained what successful applicants can expect.

“Each product airlock will be set up and tailored to the specific needs of the innovation, to be flexible to potential issues and to maximize opportunities to explore concerns within acceptable risk levels,” MHRA said. “Successful applicants to the AI Airlock will be required to work collaboratively and transparently with the project team. Afterwards, all parties will produce reports from their perspectives, summarizing the achievements and lessons learnt to inform regulatory policy and guidance.”

MHRA will work with partners on the pilot, including approved body trade group Team AB and the National Health Service (NHS). The agency said Team AB's involvement could make the interpretation of UK medical device regulatory requirements more consistent. Many AIaMD products will ultimately be used in the NHS.

Press Release, MHRA Notice

Trade groups warn EU compulsory licensing plan will undermine innovation

EFPIA, MedTech Europe and other trade groups have warned that the proposed regulation on compulsory licensing for crisis management “will undermine innovation and competitiveness of European companies.”

Last year, the European Commission proposed creating a compulsory licensing mechanism at the EU level. Officials identified the mechanism as a way to provide access to key products and technologies when voluntary agreements are unavailable or inadequate. The Commission said acting at an EU level, rather than using the current national powers, would cover cross-border supply chains.

The plan has “problematic provisions” such as inadequate judicial review and forced technology transfer despite improvements made by the European Parliament, according to EFPIA, MedTech Europe and three other organizations.

The groups would like authorities to make it clear that “compulsory license is a last resort measure, where it ‘is the only means’ to generate access to ‘indispensable,’ crisis-relevant products,” according to a joint statement. They are also pushing for explicitly excluding “trade secrets and know-how” from the policy’s scope.

Other recommendations include developing clearer definitions, including “crises,” and including industry experts on a board that will advise the Commission. The final point relates to judicial review.

“A thorough judicial review of a compulsory license must be made,” the organizations said. “Right holders should always be given an opportunity to be heard prior to the adoption of any decision on compulsory licensing and to negotiate the ‘adequate remuneration’ or to propose an alternative measure, for example, around production capacity or cooperation agreements.”

Joint Statement

EDQM seeks feedback on new general texts on mRNA vaccines

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is consulting new general texts on mRNA vaccines.

EDQM cites the rapid development of the mRNA vaccine field and the modality’s ongoing evolution into “an increasingly important technology tailored to fight different infectious diseases.” The company adds that the changes show the need for common quality standards.

The European Pharmacopoeia responded with three new general texts addressing key aspects of the production and control of mRNA vaccines and components. The texts cover mRNA vaccines for human use, mRNA substances vaccines for human use and the DNA template for the preparation of mRNA substances.

EDQM said the documents are intended to support developers, manufacturers, regulatory agencies and national control laboratories worldwide. The drafts are open for comment until 30 June.

EDQM Notice

MHRA switches adverse incident databases this month

MHRA is preparing to deploy a new adverse incident database over the weekend of 25-26 May. Any files sent after 6 am UK time on 24 May will enter a queue to join the new database when it goes live on 28 May.

The new database complies with the ICH ICSR R3 standard and conforms to the EU’s implementation guidance. In June 2022, the European Medicines Agency moved its EudraVigilance adverse reaction reporting system to the R3 format.

MHRA has based its new database on the R3 standard, although it will be able to convert R2 standard XMLs into the R3 standard for ingestion. After the new system goes live, the agency will continue to accept individual case safety reports (ICSRs) in the R2 and R3 standards. MHRA will acknowledge ICSRs sent before the switchover in R2 and use R3 for files sent after 6 am on 24 May.

“All XML files sent from MHRA will be in the R3 standard format,” the agency said. “This includes both [anonymized single patient reports] and acknowledgments. It is important that your systems and/or procedures can receive and manage files in the R3 standard effectively, as our new systems will not be able to send R2 files.”

MHRA Guidance

Dutch MEB validates quality of asthma inhaler linked to cough complaints

The Dutch Medicines Evaluation Board (MEB) has found no problems with the quality of an asthma inhaler linked to hundreds of complaints.

Viatris won approval for an inhaled formulation of beclometasone and formoterol in the Netherlands in 2022. From late August 2023 to late March 2024, the Dutch pharmacovigilance center received 446 complaints, mostly from people who had switched to Viatris’ inhaler after taking another formulation of beclometasone and formoterol. Viatris’ inhaler uses a different excipient than the other product.

Almost 300 reports described coughing during or immediately after inhalation. Most affected patients either stopped using the inhaler or switched to the other formulation.

MEB's assessment of the production process, ingredients, and other factors that affect quality found no issues. The agency continues to look for an explanation for the reports and plans to share its findings in the fall. Viatris’ inhaler remains on the market, and patients with no complaints can continue to use the product.

MEB Notice (Dutch)

Euro Roundup: MHRA launches AI Airlock

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