Euro Roundup: UK clinical trial reforms take effect in biggest regulatory shift in 20 years
New clinical trial regulations came into force in the UK this week, marking the biggest change in the law on running human studies in the country in more than 20 years.
The reforms introduce notifiable trials, offering an accelerated route for starting lower-risk studies. Trials that meet the notifiable study criteria will receive automatic authorization from the licensing authority, although sponsors will still need a favorable ethics committee opinion before enrolling patients. The UK has also established a notification process for some modifications to existing studies.
Other changes are intended to reduce the administrative burdens associated with safety reporting. The reforms end the need for sponsors to report suspected unexpected serious adverse reactions directly to investigators and ethics committees. Sponsors now have seven days, rather than three days, to notify the Medicines and Healthcare products Regulatory Agency (MHRA) in writing about urgent safety measures.
“These reforms to clinical trial regulations are a boost both for patients and industry investment in R&D in this country,” MHRA Chief Executive Lawrence Tallon said. “They will help to make the UK a more attractive, internationally competitive destination for both commercial and non-commercial clinical research.”
Draft guidelines published by MHRA ahead of the implementation date took effect alongside the new regulations. On the day the regulations took effect, the agency shared new guidance on formulating responses to good clinical practice (GCP) inspection findings, notifying officials on serious GCP breaches, and studying radiopharmaceuticals.
MHRA also published details of its performance in its 2025 to 2026 financial year on the same day. The agency has maintained its performance since clearing the backlog of clinical trial applications that accumulated in the aftermath of Brexit, assessing 100% of submissions on time in the financial year. The number of clinical trial applications assessed by MHRA increased 1% to 5,116.
That figure could increase in the coming years if the reforms achieve the government’s goal of making the UK a more attractive location for clinical research. MHRA has laid the foundations for supporting an uptick in activity. The agency grew its headcount by 20% between 2024 and 2026 and, having faced funding difficulties in recent years, said it ended the year with “a healthy financial surplus.”
EMA tasks advisory group with assessing how to tackle vaccine hesitancy
The European Medicines Agency (EMA) has created an advisory group on vaccine confidence to support its work to strengthen trust in the products.
EMA has staffed the advisory group with more than 20 high-level European and international experts who met for the first time this week. The formation of the panel reflects the belief that vaccine hesitancy is a growing threat to public health because it could enable infectious diseases to re-emerge. EMA sees a role for itself in sharing data and explaining the science to support informed decision making.
“The establishment of this new group, bringing together some of the most recognised voices on vaccine confidence, is an important step forward in strengthening our efforts to rebuild trust, protect communities and save lives,” EMA Executive Director Emer Cooke said.
EMA has tasked the group with advising on and contributing to the analysis of vaccine hesitancy and giving feedback on the agency’s efforts to increase confidence in the products. The group’s other main objectives are to contribute to improving EMA’s communication to the public on the benefits and risks of vaccines and to help amplify the agency’s science outreach and public health messages.
The academics and representatives of healthcare professionals, medical societies, patient organizations, and public health bodies who sit on the panel will meet quarterly. The advisory group is part of EMA’s wider vaccine outreach strategy.
Through the strategy, EMA is identifying and addressing public concerns that may affect confidence in vaccines, collaborating with healthcare professionals and public health initiatives, and developing communication materials and campaigns.
EMA named a collaboration with the European Academy of Paediatrics on a communication tool to support vaccine literacy, Vaccine Essentials, as an example of its work. The advisory group will advise on further issues of Vaccine Essentials.
EDQM updates guideline on revising and renewing certificates of suitability
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has aligned its guideline on revising and renewing certificates of suitability (CEPs) with European Union legislation.
The guideline covers the need to inform EDQM of changes to a CEP, a document that certifies an active pharmaceutical ingredient or excipient complies with European Pharmacopoeia standards. Topics covered in the guideline include how to classify CEP changes, the documentation needed to support revisions, and the process for renewing certificates as they near the end of their five-year validity periods.
EDQM, which will implement the updated guideline in July, has changed the document to reflect the adoption of the EU variations guideline and revisions to the certification procedure. The directorate also made changes in response to the EU regulation on veterinary medicinal products.
In a new introductory paragraph, EDQM encouraged CEP holders to submit all annual notifications together once a year, adding that they “may also be submitted accompanied by other types of changes.” Companies that pool different types of changes must submit and handle the group according to the “highest” revision type, EDQM said.
EDQM reminded CEP holders of its approach to notification submissions that include changes that cannot be classified as notifications. The directorate will reject the submission, forcing the company to resubmit using the correct classification and provide the associated documentation and fee. EDQM also addressed the potential to change the CEP format in light of the implementation of the CEP 2.0.
Swissmedic probes post-market surveillance compliance for medical devices
The Swiss Agency for Therapeutic Products (Swissmedic) is picking a random sample of medical devices to evaluate compliance with post-market surveillance documentation.
Swissmedic performed a similar probe in 2024, three years after implementing rules on post-market surveillance. The agency found non-conformities in the paperwork of 20 out of 30 legacy devices in risk classes IIa and higher. Swissmedic said 11 products either lacked a plan or had an inadequate plan. The agency urged all manufacturers to review their processes and documentation in light of its findings.
Last week, Swissmedic wrote to manufacturers and authorized representatives about its plan to run a new assessment of compliance with the rules. The agency will select a specific number of Class IIa, IIb, and III devices at random. The manufacturer or authorized representative responsible for the devices will need to provide the associated post-market surveillance documentation.
Other News:
Generic drugmakers including Sandoz, Teva Pharmaceuticals, and Viatris appealed to the European Court of Justice regarding the Urban Wastewater Treatment Directive. The companies believe the directive enforces discriminatory and legally flawed cost allocations. Under the current proposal, the companies warn they face imminent, irreversible decisions about whether to make drugs in Europe. Press Release
EDQM has launched the European Drug Shortages Formulary (EDSForm) platform. EDSForm features monographs describing methods for the compounding of medicines that may be used when licensed alternatives are unavailable. EDQM created the platform to give healthcare professionals standardized formulations that can be prepared safely and effectively when shortages occur. EDQM Notice
