Euro Roundup: MHRA publishes guidance on clinical trial processes under incoming UK regulations
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has laid the groundwork for the implementation of new clinical trial regulations in April 2026 by publishing a series of guidelines.Officials have called the new regulations the biggest change in the framework for running clinical trials in the UK in 20 years. The new regulations allow sponsors of lower-risk clinical trials to use a notification scheme for initial applications and modifications, formalize combined reviews of regulatory and ethics submissions and aim to reduce the time from application to first participant from 250 days to 150 days.
This week, MHRA released eight guidance documents to support the implementation of the regulations. The texts are drafts and should only be used to support sponsors in preparing for the implementation of the new regulations. Sponsors can submit feedback on the draft documents.
The documents cover steps in the clinical trial process from filing to test a drug in humans to ending a study. The guidance on applying to run a clinical trial describes the combined ethics-regulatory review process. Sponsors will file a single application through the Integrated Research Application System for review in parallel by the licensing authority and a suitable research ethics committee.
“In exceptional circumstances, an applicant may submit separate applications to the licensing authority for a clinical trial authorisation and to an ethics committee for a favourable opinion,” MHRA said. “Written approval must be obtained in advance by contacting the licensing authority. Requests to make separate applications will be assessed on a case-by-case basis.”
MHRA has provided separate guidance on notifiable trials. The text explains which studies are eligible for the notification pathway, which grants automatic approval to applicants, and outlines the process for applying to run a notifiable trial. Sponsors will use the same combined review process as applicants that need to seek approval for their studies.
The other guidance documents cover topics including expert advice, labelling, managing safety events and non-investigational medicinal products. MHRA has also explained the transitional arrangements. The old rules will apply to trials submitted for approval before 28 April 2026, even if the licensing authority and ethics committee issue decisions after the new rules come into effect.
MHRA Guidance
EMA starts consultation into epidemiological data on blood transmissible infections
The European Medicines Agency (EMA) is seeking feedback on plans to update one chapter of its guideline on epidemiological data on blood transmissible infections.
The full guideline outlines the requirements for epidemiological data on blood transmissible infections to be included in applications for plasma master file (PMF) certification sent to EMA. Officials are planning to update the chapter on monitoring change over time and alert limits. The changes reflect experience gathered during annual updates and requests from the plasma fractionation industry for guidance.
“Experience accumulated in recent years of PMF evaluation reveals that a more detailed guidance for PMF holders needs to be provided on the calculation of alert limits, which impacts on the information to be submitted in the dossier,” EMA said.
The updated guideline provides guidance on the definition of alert limits by type of donor, viral marker rates, the criteria for periodic recalculation of limits, statistical models for calculating limits and the data PMF holders should submit for regulatory assessment.
EMA is accepting feedback on the draft until 31 August.
Draft Guideline
MHRA outlines business strategy for coming year after securing funding boost
MHRA has published its business strategy for 2025 to 2026, setting out its priorities for a period in which it has secured a two-fold increase in funding.
The extra funding reflects increases in MHRA’s fees and additional support from the Department of Health and Social Care (DHSC). MHRA has received extra funding from DHSC to invest in its scientific campus and IT program. The IT program is intended to enable “better customer service and faster, risk-proportionate and more efficient approvals,” the agency said.
MHRA’s priorities for the year include changes to its interactions with the National Institute for Health and Care Excellence (NICE). The agency wants to improve alignment between MHRA regulatory decisions and NICE guidance publication to minimize delays to patient access of medicines. Officials also plan to launch an integrated premarket scientific advice service with NICE.
Other objectives include the implementation of the next phase of the AI Airlock program, which provides a testing space to assess experimental AI before it is used in the real world. MHRA began accepting applications for the second round of the program this week. The agency has secured further funding to expand beyond the four devices it accepted in the first round of the program.
MHRA Plan, Press Release
European Commission bars Chinese companies from some medtech contracts
The European Commission has excluded Chinese companies from EU government purchases of medical devices exceeding €5 million ($5.8 million).
Officials imposed the restriction after finding discrimination against EU medical devices in China’s public procurement market. The Commission said its response “is proportionate to China’s barriers, while ensuring that all the necessary medical devices are available for the EU healthcare system.” Exceptions will be made when no alternative suppliers exist.
The Commission said its action is intended to “incentivise China to cease its discrimination against EU firms and EU-made medical devices and treat EU companies with the same openness as the EU does with Chinese companies and products.” Chinese medical device exports to the EU doubled from 2015 to 2023, the Commission said, but 87% of Chinese procurement procedures restricted access to EU devices.
If China offers “concrete, verifiable and satisfactory solutions that effectively address the concerns,” the Commission said it can suspend or withdraw its procurement access restrictions.
Press Release
EU and Canada agree to strengthen cooperation on medical countermeasures
The European Health Emergency Preparedness and Response Authority (HERA) has agreed to strengthen cooperation with its Canadian counterpart.
HERA will work with Health Emergency Readiness Canada to develop and strengthen cooperation on medical countermeasures against serious cross-border public health threats. The collaborators will focus on research and innovation, addressing commercialization and scale-up challenges and supply chain resiliency.
“Cooperation, coordination and communication are essential in response to health emergencies, but also to prepare for future serious cross-border public health threats,” Hadja Lahbib, EU commissioner for equality, preparedness and crisis management, said.
The arrangement will last for five years.
Press Release
Other News:
EMA has started a review of sodium oxybate in alcohol withdrawal syndrome and to support long‑term abstinence. The regulator began the review after the French medicines agency raised concerns about the effectiveness of sodium oxybate in alcohol dependence during an assessment of a generic medicine. Sodium oxybate is authorized in Austria and Italy for use in alcohol‑dependent patients. EMA Notice
The Federal Council has approved the appointment of Vincenza Trivigno as head of the Swiss Agency for Therapeutic Products (Swissmedic). Trivigno, who was CEO of a company that manages clinics and an outpatient rehabilitation center, will succeed Raimund Bruhin in January 2026. Swissmedic said Trivigno has the skill to address challenges such as the digitalization of tasks. Swissmedic Notice
The European Commission published an expert panel opinion about a notified body’s review of a filing for a mechanical ventilator. The report states there are inconsistencies in the documents presented by the notified body that “make us question the potential impact on health and the novelty of the device.” Expert Opinion
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