The MHRA has provided a link to the webinar of Tuesday 15 October 2024 on Implementing the new UK Clinical Trials regulations.
This webinar details the upcoming implementation of new clinical trial regulations in the UK.
- The speakers, primarily from the MHRA and the Health Research Authority (HRA), outline the key changes in the new regulations, which aim to:
- streamline the approval process
- enhance research transparency
- update good clinical practice standards, and
- improve manufacturing and safety reporting.
- The webinar also emphasized the importance of stakeholder engagement in the development of guidance for the new regulations.
- The speakers highlighted their commitment to involving stakeholders throughout the process, including surveys, webinars, workshops, and email communications, to ensure the guidance is clear, effective, and implemented successfully in January 2026.
- The overall purpose is to create a more efficient and responsive clinical trial ecosystem that prioritizes patient safety, innovation, and the UK’s standing as a destination for international clinical trials.
How you might use this post
One way in which you could use this post is to read the section below entitled Content from the webinar as a starting point in order to familiarise yourself with the content provided in brief and then to reinforce that by listening to the webinar at the this link.
Use of AI to write this post
It might interest you to know that for the first time, I have used help from Artificial Intelligence to write this post. Specifically, I have used the product Notebook LM by Google. On the whole it was a much more laborious process in spite of AI assistance because it meant that I had to go through the transcript of the webinar line by line to ensure that the output from Notebook LM was consistent with the content from the webinar, without any significant alterations. This meant that I have had to make amendments, additions and deletions to the output from Notebook LM.
Content from the webinar
Below, the content from the webinar is organised by topic as shown. Some detail is provided under five heading headings.
I. Opening Remarks: The New UK Clinical Trials Regulations – 0 – 4.37 mins
Dr. Raine emphasized the importance of the new regulations, highlighting key goals:
- Prioritizing patient safety and accessibility to clinical trial benefits
- Creating a streamlined, agile, and responsive framework
- Establishing a proportionate and flexible regulatory environment for new science and technology
- Solidifying the UK’s standing as a hub for international trials
II. Webinar Agenda – 4.43 – 14.29 mins
The webinar agenda was outlined as follows:
- Legislative updates from the MHRA partnerships group.
- Detailed discussion of the guidance development plan, involving both MHRA and HRA, and stakeholder engagement.
- Overview of the clinical trials roadmap, covering implementation and transition to the new regulations.
- Open Q&A session, moderated by James Pound with contributions from MHRA and HRA colleagues, addressing questions submitted through Slido.
- Concluding remarks and a call to action for attendees on next steps and involvement opportunities.
III. Legislative Updates: Key Changes and Timelines – 5.40 – 13.26 mins
A comprehensive overview of legislative changes was delivered as follows:
- Aims to simplify and streamline the approval of clinical trial applications
- Four main themes of the reform:
- Ensure patients and their safety are the focus of all clinical trials and bring the benefits of clinical trials to everyone
- Create a proportionate and flexible regulatory environment
- Cement the UK as a destination for international trials
- Provide a framework that is streamlined, agile and responsive to innovation.
- Changes to the approval process are to simplify and streamline the approval of clinical trial applications including:
- a single application route with coordinated regulatory and ethics review leading to a single UK decision for a clinical trial
- updated application review timelines e.g. 30 days post-validation for a combined decision), and
- a notification scheme for initial clinical trial applications (to get automatic regulatory approval) and certain modifications modifications of an important and administrative nature e.g. change of the sponsor’s legal representative..
- changes to research transparency:
- Legislative requirement for trial registration on a public registry before commencement
- public results summary to be published within one year of trial completion (with deferral or waiver options) and
- legislative requirement for the provision of lay summaries in a suitable format to participants.
- good clinical practice:
- requiring compliance with overarching principles aligning with ICH guidelines ensuring that international standards are met and
- acceptance of UK clinical trial data globally.
- manufacturing and assembly:
- defining non-investigational medicinal products which are often used in support of a clinical trial, but are not the actual subject of subject medicine of the trial which would allow the concept to be extended to non-medicinal products, such as challenge agents
- extending current exemptions for holding a manufacturing authorization specifically for investigational medicinal products will also be extended to include diagnostic radio pharmaceuticals within a clinical trial
- allowing greater flexibility in labeling clinical trial medicines for example, by enabling a licensed medicinal product that is subject to the trial to have reduced specific clinical trial labelling where appropriate.
- safety reporting:
- reducing duplicative requirements and
- replacing listings of adverse events in annual reports with a narrative evaluation of how safety concerns have been evaluated and interpreted.
- Timelines for legislation:
- Ministerial approval secured, legal drafting in final stages, aiming for legislation laying in November 2024, followed by parliamentary debates, a 12-month implementation period, and anticipated implementation in January 2026 with clear transitional arrangements.
IV. Guidance Development Plan – 14.29 – 26.19 mins
Guidance development and stakeholder engagement was discussed:
- Emphasized the guidance development process, including:
- collaboration with internal and external partners
- consideration of existing regulatory guidance, and
- openness to stakeholder input and feedback.
- Seven main guidance topics:
- requests for clinical trial approval
- modifications to approvals (note that what are referred to as amendments now will be called modifications in the new clinical trials regulation and guidance)
- modifications for initial applications and amendments
- safety
- research transparency
- seeking and recording concerns, and
- ending a clinical trial.
- Other updates to clinical trial legislation, categorized as:
- broad changes (e.g., adoption of ICH GCP 6R3 principles) the enshrinement of risk proportionality and risk
- assessment within the legislation and then greater transparency for sponsor responsibilities and oversight
- specific changes (e.g., archiving requirements for the retention of records for a longer period of time, labeling requirements for investigational products and some aspects around radiopharmacy), and
- updates relevant to regulatory functions.
- HRA-led guidance areas, including:
- transparency provisions for clinical trials which will cover things like how the deferral request mechanisms will work in practice and expectations around arrangements for offering a lay summary of results to participants and legal representatives
- simplified consent procedures for low-risk trials
- inclusion and representation in trials which aims to ensure that clinical trials include people who could reasonably be impacted by the research findings and ensure that people who are commonly underserved by research are not being overlooked, and
- public involvement in phase one healthy volunteer trials.
- Five-step guidance development process between MHRA and HRA:
- stakeholder engagement with draft guidance (Nov 2024 – March 2025)
- Final draft guidance published (Mar – Apr 2025)
- Further comments on the final guidance (Apr – Jun 2025)
- Aiming to publish final version of the adopted guidance (Aug 2025)
- Guidance becomes ‘live’ subject to parliamentary processes (Jan 2026)
- Overview of the clinical trials roadmap, outlining timelines for parliamentary processes, guidance development, and finalization, emphasizing stakeholder involvement through sharing drafts, workshops, webinars, website updates, and an iterative approach
V. Stakeholder Engagement and Call to Action – 26.19 – 30.16 mins
The Concluding remarks:
- Reiterated the commitment to stakeholder engagement in guidance development and the importance of timely preparation for implementation
- Encouraged stakeholder involvement through the upcoming survey to express interest in different guidance areas, enabling the formation of representative engagement groups and workshops
- Provided information on staying updated through various channels:
- HRA website
- MHRA news
- social media, and
- future webinars.
Source: MHRA