Euro Roundup: UK introduces legislation to speed up trial approvals, encourage innovation
Legislation to reduce unnecessary administrative burdens on sponsors of clinical trials has been introduced in the UK Parliament and will be debated in 2025, positioning the new rules to take effect early in 2026.The legislation seeks to enshrine “combined review” into law for the first time. The combined review process enables research teams to seek approval for new trials from a Research Ethics Committee and the Medicines and Healthcare products Regulatory Agency (MHRA). UK officials see combined review to ensure trial applications are processed within the targeted timelines.
The legislation also would codify MHRA’s notification scheme into law. MHRA proposed the scheme in its consultation on clinical trials in 2022. With 74% of respondents endorsing the proposal, the agency advanced the initiative last year. MHRA will process initial applications for the lowest-risk Phase 3 and 4 trials within 14 days, instead of the statutory 30 days. Applicants need to meet certain criteria to benefit from the shorter timeline.
Informed consent is changing for lower-risk trials. The simplified means of seeking and recording consent will apply to trials of approved medicines that pose minimal risk to participants. The UK Health Research Authority (HRA) is running a consultation into the alternative approach to informed consent.
Transparency is another focus of the legislation and would legally require sponsors to list clinical trials in a public register recognized by the World Health Organization and share a summary of results within 12 months of the study’s end. Sponsors would need to share the findings of trials in language that participants in their studies can understand.
Other changes center on Research Ethics Committees. The 2004 legislation that currently covers trials in the UK imposes specific requirements on the make-up of the committees and how they function. HRA received feedback that the requirements are restrictive, leading officials to propose dropping the specific rules and aligning with international good clinical practice standards.
The legislation is part of a broader set of documents about trials in the UK. MHRA and HRA are creating guidance on public involvement in the design, conduct and dissemination of trials and the diversity of people taking part in studies. The aim is to ensure research findings improve everyone’s care and help address health inequalities.
Press Release, More
Pilot finds EU ready for phased implementation of electronic product information
The European Medicines Agency (EMA) is moving toward the phased implementation of electronic product information (ePI) after a pilot project found the regulatory system is “generally prepared” for the technology.
EMA ran the pilot to explore the creation and testing of ePIs in real regulatory procedures. The project identified the need for more development, such as additional functionalities and integration with current IT systems, that the agency plans to carry out next year. Beyond that, EMA envisages a phased rollout of ePI, starting with voluntary adoption for centrally authorized products.
The pilot largely met the key performance indicators identified by EMA. Objectives for the editor used for ePI creation were only partly met. Some participants in the pilot found they could not easily add non-mandatory sections to their ePIs, were unhappy with the formatting of content pasted from Word or were dissatisfied with image insertion. EMA identified other areas where further work is needed.
“The processes defined in the ePI Procedural Guides were satisfactory for the low number of short, straightforward regulatory procedures in the pilot. However, the guides must be extended to incorporate all regulatory procedures, and linguistic review processes,” EMA said.
Press Release
EU countries step up cooperation on studies of medicines and medical devices
European countries have endorsed a new strategy for a program intended to foster collaboration between national authorities responsible for clinical trials and medical devices.
The European Commission launched the COMBINE initiative in June 2023. The program was designed to analyze the root causes of the challenges faced by sponsors of combined trials of medicines and medical devices and identify potential solutions. The initiative reflected concerns about the impact of the device and diagnostic regulations on combination studies.
The endorsement of national authorities supports the roll out of the program over the coming years through seven cross-sector projects. Goals include piloting a single assessment process for multi-country combined studies across device and medicinal product regulations and harmonizing serious adverse event reporting processes.
Other objectives include clarifying questions on the interface between clinical trials and medical device regulations and exploring opportunities for advising sponsors and enabling knowledge exchange among national authorities.
The areas of focus emerged from an analysis phase that identified 78 issues and more than 50 possible solutions. The breadth of activities, some of which are already underway, led EMA to frame the program as a set of interlinked projects and collaborating groups.
Press Release
EMA updates Q&As on scientific advice, generics, biosimilars and cooperation
EMA has updated multiple question and answer documents, providing new guidance on scientific advice, generics, biosimilars and cooperation with the World Health Organization (WHO).
Changes to the Q&A on scientific advice include a new question on how to request a fee reduction for entities not engaged in economic activities. Applicants that want a 100% reduction in the scientific advice fee need to submit a request for verification of their compliance with the regulations covering entities not engaged in economic activities.
The Q&A on procedural advice for users of the centralized procedure for generic or hybrid applications has updated responses to four questions. The update covers questions on topics such as when to send a safety variation for a generic or hybrid medicinal product following changes to the reference medicinal product.
EMA also updated its Q&As on centralized biosimilar applications and on medicinal products intended exclusively for markets outside the European Union in the context of cooperation with WHO.
Scientific Advice, Generics, Biosimilars, WHO Cooperation
Commission adopts implementing regulation on joint scientific consultations
The European Commission has adopted an implementing regulation on the rules for joint scientific consultations under the Health Technology Assessment (HTA) Regulation.
Under the regulation, health technology developers will exchange information with HTA bodies on their development plans through joint scientific consultations. The consultations also provide developers of medicinal products with opportunities to gain guidance on the clinical information, data, analyses and other evidence they are likely to need for the joint clinical assessment.
The implementing act provides procedural rules for the submission of requests from health technology developers and the selection and consultation of stakeholder organisations, patients and experts. Other parts of the act cover requests for joint scientific consultations to be carried out in parallel with EMA’s scientific advice process.
Commission Notice
Other news:
A notified body industry group has published a consensus document on the certification process for medical devices. The Team-NB document describes the pre-application and application processes that companies can follow when seeking certification from notified bodies under the European Union’s Medical Device Regulation. Consensus Document
EMA’s Big Data Steering Group (BDSG) has published its 2024 report. The document covers the highlights of the BDSG and artificial intelligence work plans for 2024. BDSG Report
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