Euro Roundup: MHRA shares clinical trial guidance ahead of April switch to new UK legislation

The Medicines and Healthcare products Regulatory Agency (MHRA) has published and updated multiple guidance documents in preparation for changes to the UK’s clinical trial legislation.

With the updated regulations taking effect on 28 April, MHRA has compiled 14 guidance documents on a wide range of topics about medicine trials. The documents are currently drafts and sponsors should only use them to help prepare to meet the incoming requirements. All the documents were created or updated this week.

The four new documents cover alignment of the legislation with the Declaration of Helsinki, expanded enforcement provisions, archiving and retaining records, and UK-specific annotations to International Council for Harmonisation (ICH) guidelines.

MHRA said that sponsors should generally keep records for at least 25 years after the trial ends, although the exact retention period varies depending on the type of study and applicable regulations. The new rules require sponsors to ensure secure storage, controlled access, and protection against unauthorized alteration or destruction.

The agency said it is essential for sponsors and investigators to establish agreements that clearly define who is responsible for archiving and maintaining records. Failures related to record keeping associated with serious adverse events and reactions are among the new offences under the incoming expanded enforcement provisions.

Other new offences cover non-investigational medicinal products, the notification scheme, transparency requirements, and the lapse of clinical trial approval. “Sponsors and applicants should be aware that notifications of an important detail or making a modification request to the MHRA or ethics committee which contain false or misleading information may have action taken against them,” the agency said.

The other new documents address the interaction between the UK legislation and international texts. MHRA said compliance with the principles of the Declaration of Helsinki is required by the amended UK regulation. If there is a conflict between the domestic and international requirements, sponsors should prioritize compliance with UK law while documenting the rationale for the deviation and any impacts.

Annotations to ICH E6(R3), a globally harmonized good clinical practice guideline, explain how specific sections of the international text interact with UK law. The agency said the annotations are intended to help sponsors comply with ICH E6(R3) “by specifying what the applicable regulatory requirements or relevant guidance documents are for the UK.”

MHRA, which is seeking feedback on the drafts until 8 February, shared the guidance documents the day before providing an update on clinical trial activity in the UK. The number of clinical trial applications rose 9% over the first nine months of 2025 compared with the same period of 2024, MHRA said.

Growth was strongest in early and innovative research, according to the agency. Filings to run studies involving healthy volunteers were up 16%. The agency reported a 75% increase in the number of clinical trial scientific advice meetings. MHRA’s data suggest the upswing in activity seen in 2022, 2023, and, in particular, 2024 continued into last year.

MHRA Hub, Press Release

Commission warns ‘structural vulnerabilities’ are offsetting regulatory advances

The European Commission has warned significant regulatory advances on pandemic preparedness and response capacities are increasingly being offset by “structural vulnerabilities.”

Officials examined cross-border health risks to the European Union in the Comprehensive Health Threat Prioritisation Assessment for Medical Countermeasures, a document created as part of the new Medical Countermeasures Strategy. Through the assessment, the Commission identified four major categories of threat, such as potentially pandemic viruses, and evaluated the EU’s ability to defend against them.

The review of viruses with epidemic and pandemic potential concluded “significant regulatory, scientific, and organizational advances have improved pandemic preparedness and response capacities.” Yet the Commission warned structural vulnerabilities such as health workforce shortages, fragile supply chains, funding fluctuations, and incomplete institutionalization of lessons learned are offsetting the gains.

While the Commission gave a favorable review of regulations covering viral threats, which were shaped by the COVID-19 pandemic, it identified a need for changes to address other risks. Assessing the threat posed by antimicrobial resistance, the Commission reviewed the potential for phage therapy to address the shortcomings of existing medical interventions.

The European Medicines Agency (EMA) told the Commission that the limited number of phage therapy clinical trials partly reflects “the lack of distinct regulatory and scientific guidance throughout the life cycle.” EMA flagged the “relative paucity of clinical and manufacturing experience with phage therapy products” as another, interconnected cause of the limited clinical development activity.

In recent years, EMA and its peers have published phage therapy documents to address the prior lack of regulatory guidance on the modality. EMA shared a concept paper about developing and manufacturing phage therapies for human use in 2023.

Press Release, Commission Report

EMA targets second quarter launch for breakthrough medical device pilot program

EMA has outlined plans to launch a pilot program in the second quarter to implement recent guidance on breakthrough devices (BtX).

The European Commission’s Medical Device Coordination Group (MDCG) published guidance last month to establish a framework for breakthrough devices aligned with the medtech regulations. MDCG defined a BtX as a device with a significant level of innovation in technology, clinical procedures, or its application in clinical practice that is expected to have a significant positive impact on patients and public health.

As part of its guidance, MDCG outlined a process for securing BtX designation by seeking scientific advice from the expert panels. EMA will pilot the approach starting in the second quarter, giving companies a way to access enhanced regulatory support and priority scientific advice from its medical device expert panels.

The agency plans to publish detailed guidance before launching the pilot.

EMA Update

European Pharmacopoeia publishes general chapter on managing digital data quality

The European Pharmacopoeia (Ph. Eur.) has published a new general chapter establishing a framework for managing digital data quality across its entire life cycle.

Ph. Eur. created the chapter to address data quality, with a particular focus on data of digital origin. The framework introduces concepts related to accuracy, bias, completeness, and reproducibility, a process for managing data throughout its life cycle, and an overview of data sources and storage formats. Ph. Eur. has also addressed the role of experts, especially in relation to automated decision-making systems.

The European Directorate for the Quality of Medicines and HealthCare called the chapter “a significant step in the Ph. Eur.’s adaptation to the evolving digital landscape,” adding that it will ensure data used in decisions concerning pharmaceutical quality “is robust, reliable and well-governed.”

As part of Ph. Eur. Issue 12.3, the data quality general chapter will come into force on 1 July.

Press Release

Other News:

The EU’s health technology assessment (HTA) coordination group has published a report on emerging health technologies. Created in accordance with the HTA regulation, the report provides an anonymized, aggregated overview of the medicines and medical devices that may be eligible for joint clinical assessment this year. HTA Report

Vincenza Trivigno has become executive director of the Swiss Agency for Therapeutic Products. Trivigno succeeded Raimund Bruhin, who has led the agency since 2018 and is retiring in February. Swissmedic said Trivigno starts at a time of important decisions, including about consolidating financial framework conditions, developing digitalization, and strengthening international cooperation. Swissmedic Notice

Euro Roundup: MHRA shares clinical trial guidance ahead of April switch to new UK legislation

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