Euro Roundup: MHRA outlines plans to recognize drug approvals from 7 global regulators

From the first quarter of 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) will implement an international recognition framework for medicines designed to “make the most of the expertise and decision-making of trusted regulatory partners to streamline assessments of specific products” thereby saving companies money and accelerating access, according to a 26 May statement from the regulator.

The framework will rely on approvals from Australia, Canada, the EU, Japan, Switzerland, Singapore and the US. MHRA already has some form of reliance agreement with most of the regulators through the Access Consortium and Project Orbis. The temporary, post-Brexit EU reliance routes are set to expire at the end of this year, but the other initiatives will run in parallel to the recognition framework.

In March, the UK government awarded MHRA £10 million ($12 million) to establish an international recognition framework. The government pitched the changes as a way for MHRA to grant “near automatic sign-off for medicines and technologies” approved in Europe, Japan and the US.

At this stage, it is still being determined exactly what a drugmaker with approval in one of the seven partner regions will need to do to bring a medicine to market. While the government spoke of “near automatic sign-off,” MHRA emphasized that it “will maintain rigorous scrutiny and retain the authority to reject applications if the evidence provided is considered insufficiently robust.”

The plans outlined by MHRA last week only cover medicines, but the agency wants to establish a similar system for medical devices. MHRA plans to gather information on recognition routes for medical devices in a “targeted consultation ... that will gather views on a wide range of topics, including recognising conformity assessments or approvals from international regulatory partners.”

Press Release

EMA plots 1-year pilot project to test electronic product information for regulatory procedures

The European Medicines Agency (EMA) and national regulatory agencies are piloting electronic product information (ePI) generation for regulatory procedures.

EMA defines ePI as authorized, statutory product information for medicines, including the summary of product characteristics, package leaflet and labeling, adapted for handling in an electronic format and for dissemination online and in print. The agency sees switching to ePI as a way to improve accessibility, searchability and multilingual capabilities and to keep information up to date.

EMA has partnered with regulatory agencies in Denmark, Netherlands, Spain and Sweden. Starting in July, the partners will spend a year using an ePI authoring tool in the Product Lifecycle Management (PLM) Portal.

EMA created the PLM Portal to manage electronic application forms, ePI and authorized product data in the EU. In the pilot project, EMA and its collaborators will use the authoring tool in the portal to generate ePI for regulatory procedures in real-time. Once regulators approve the ePI, they will make it available publicly.

The pilot will cover centralized and national procedures. As the pilot progresses, EMA will share updates on its work on ePI, which uses a semi-structured format based on a common electronic standard for product information, as part of its quarterly public system “demo events.”

EMA Notice

MHRA seeks applications for regulatory pathway designed to improve access to innovative devices

MHRA is setting up a new regulatory pathway that will enable developers of innovative medical devices to receive integrated regulatory and market access input intended to bring technologies “to the forefront of the National Health Service.”

Companies that use the Innovative Devices Access Pathway (IDAP) will receive “a multi-partner support service including targeted scientific advice” from MHRA, the National Institute for Health and Care Excellence, Health Technology Wales and Scottish Health Technology Group, set out the goals of the pathway.

“The new IDAP will demonstrate how the UK regulator, health technology assessment and the healthcare system are working together to deliver safe, effective, and earlier innovative medical products to patients, establishing the UK as a center for medical innovation,” Marc Bailey, MHRA chief science and innovation officer, said in a statement.

MHRA “would welcome early interest from potential applicants, so we can keep them updated as this key partnership and pathway develop,” Bailey continued. The partners are encouraging companies to register for further information before the pilot launches later this year.

Press Release

European Commission creates template for notified bodies to aid extended MDR transition

The European Commission has provided a template that notified bodies can use to confirm the status of medical devices transitioning to the new regulatory regime.

Under the extended transition to the Medical Devices Regulation (MDR), products with certificates issued under the old directives can stay on the market until between 2026 and 2028, depending on risk classification. During the transition, manufacturers may need to demonstrate that their devices are the subject of an open MDR submission or are under the surveillance of a notified body.

The template features two tables. One lists devices for which an MDR application has been received, a written agreement concluded and appropriate surveillance established. The second covers devices subject to MDR applications and agreements but lack surveillance.

Commission Notice

MHRA partners with Genomics England to study the genetic drivers of adverse drug reactions

MHRA has teamed up with Genomics England to create the Yellow Card biobank to support the regulator’s efforts to assess whether specific genetic traits cause suspected side effects.

Through the initiative, the partners will collect and sequence samples from patients who have suffered suspected side effects. Initially, the project will focus on patients who experience severe skin reactions after taking allopurinol. The work could lead to tests that enable doctors to identify patients at risk of side effects before prescribing a drug.

MHRA started the pilot this week and plans to recruit participants in September. Sequencing will start in the spring of 2024 to publish initial results in 2025. The partners plan to reveal more focus areas for the pilot project soon.

Press Release

Other news:

The EU and US have reached a mutual recognition agreement to avoid the duplication of inspections of facilities that make veterinary medicines. The agreement, which comes six years after a similar pact for human drugs, sees the FDA recognize the ability of 16 member states to carry out good manufacturing practice inspections for certain veterinary products at a level equivalent to the US. EMA Notice

Euro Roundup: MHRA outlines plans to recognize drug approvals from 7 global regulators

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