Euro Roundup: European Commission seeks feedback on medical countermeasures strategy

The European Commission has published a call for evidence to inform its strategy to support medical countermeasures (MCMs) against public health threats.

Ursula von der Leyen, president of the Commission, outlined plans to present a new strategy to support MCMs against public health threats, such as those linked to chemical, biological, radiological and nuclear security, in her political guidelines for 2024-2029. Von der Leyen said joint procurement and stockpiling would be part of the plan but provided few other details.

The call for evidence provides more information on what the Commission wants to achieve and how. The goal is to provide a framework to strengthen equitable access to and supply of crisis-relevant MCMs while making the EU more competitive and innovative.

“[The strategy] will be based on HERA’s health threats prioritization,” the Commission wrote. “It will identify actions to support and accelerate R&D for MCMs; strengthen their supply chains and production capacity; and ensure their availability and equitable access. The strategy will harness tools such as joint procurement, stockpiling and innovative financial instruments.”

The Commission said the strategy will consolidate its work on MCMs over the past five years and build on the work carried out by EU countries and international partners to bridge gaps in product availability. The strategy will cover the full spectrum of products that help prepare for and respond to cross-border health threats, including vaccines, antimicrobials, medical devices, and personal protective equipment.

The strategy will propose a package of actions, policy priorities, and guiding principles to shape MCM preparedness and identify concrete flagship initiatives at the EU, national, and international levels, the Commission wrote. The call for evidence shows what the Commission aims to achieve through the actions.

“The likely impact of the strategy at EU-level is an increased coherence and complementarity of MCMs preparedness and response measures; as well as a stronger commitment to health emergency preparedness and response,” the Commission wrote. “It will contribute to the development of a strong Preparedness Union, strengthen the European Health Union and complement the Global Health Strategy – thus reinforcing the EU’s leadership in this area.”

The Commission also made the business case for the strategy, arguing that it will help make the EU more competitive in life sciences, attract investment, and provide growth opportunities. The claims come amid a focus on EU growth and innovation, which was triggered by a report the Commission ordered and then driven by pressure from industry (RELATED: Euro Roundup, Regulatory Focus, 12 September 2024)

The Commission is accepting evidence on challenges in the supply and deployment of MCMs and other topics relevant to the strategy until 9 May. The feedback will inform a Commission communication on the strategy. Through 2027, the Commission will rely on earmarked budgets under the EU4Health, Horizon Europe, and RescEU programs to support actions on MCMs.

Press Release

UK signs clinical trial regulations into law, starts 1-year transition to new requirements

The UK has signed new regulations for conducting clinical trials into law, starting a 12-month countdown to the biggest change in the country's framework for conducting studies in 20 years.

Lawmakers proposed the regulations in December. The goal was to establish a more streamlined and flexible regulatory regime while protecting the interests of trial participants. To achieve that goal, the government proposed diverging from the EU trials directive, which it said included “a large amount of detail and duplicative requirements which placed an administrative burden on the sponsor.”

Politicians proposed replacing the old EU directive, which became part of UK law before Brexit, with a framework that included a risk-based approach designed to reduce unnecessary burdens. Sponsors of lower-risk clinical trials will use a notification scheme for initial applications and modifications. Combined reviews of regulatory and ethics submissions, which were piloted in 2018, are now written into law.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) said that, by reducing red tape and simplifying approvals, the framework supports the Prime Minister’s goal of reducing the time from application to first participant from 250 days to 150 days.

The new regulations will take full effect on 10 April. MHRA said “work to bring in the new rules will continue over the coming months, backed by updated guidance and ongoing engagement with trial sponsors and researchers.” MHRA is planning to publish guidance to support researchers through the transition period and beyond.

Press Release

EMA gathers views on QRD template, adding a key information section to package leaflets

The European Medicines Agency (EMA) is running consultations into a revised quality review of documents (QRD) template and plans to add a “key information section” to the package leaflet.

EMA began an ongoing revision of QRD templates, which are designed to ensure the standardization, clarity and consistency of product information, in 2023 in response to a report that flagged shortcomings in the summary of product characteristics and the package leaflet. The proposed changes reflect the report’s recommendations, and the experience EMA has gained and the feedback it has received.

The resulting draft QRD template is intended to improve the content and structure of the package leaflet to make the document more understandable and relevant to patients. EMA is proposing to make leaflets shorter by deleting some text or making it optional, while also creating standard statements to ensure consistency and relocating important information to the start of the leaflet.

EMA, which is seeking feedback on the QRD template until 31 August, published the document alongside a call for views on another proposal. The agency is considering adding a key information section to package leaflets to “allow patients, users and healthcare professionals to rapidly identify key safety messages, balanced with information on the benefit-risk profile of the medicine.”

The proposal addresses one of the report's recommendations about improving the summary of product characteristics and the package leaflet. EMA is seeking feedback to inform a decision about whether a key information section is needed and, if so, what type of information it should cover. The consultation closes on 31 May.

QRD Template, More

MHRA publishes guidance on risk-minimization measures for medicines

MHRA has published guidance on when and how marketing authorization holders (MAHs) can take actions to minimize the risks posed by their medicines.

MAHs can independently adopt risk-minimization measures and agree on them with MHRA. In other situations, the agency will request that the MAH implement measures as a condition for issuing a product license or in response to a safety review of a particular risk.

“Before requesting that additional risk minimization measures are put into place by the MAH, the MHRA considers the likely impact of risk minimization measures on patients and caregivers; any unintended consequences such as inadvertently raising awareness of an off-label use of a medicine; and feasibility issues for the implementation of new measures in the healthcare system,” MHRA said.

MHRA listed educational tools such as healthcare professional guidance and patient cards as examples of risk-minimization measures. Other examples include controlled access programs, pregnancy prevention programs, and controlled distribution systems.

MHRA Guidance

Other news

EMA has updated its guidance on the companion diagnostic consultation procedure. The updated text advises notified bodies to submit the application for a companion diagnostic consultation procedure in the last phase of the evaluation of the marketing authorization application for its associated medicinal product. EMA Q&A

Euro Roundup: European Commission seeks feedback on medical countermeasures strategy

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