Blog: Developing our clinical trials guidance

In April 2025, the UK Parliament and Northern Ireland assembly approved the most substantial update to the clinical trials regulations since they first came into law in 2004.

The updates are intended to deliver several benefits including (but not limited to) better alignment between review and approval of clinical trials by the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committees, enhancing transparency of research, and reducing burdens for applicants and research staff.

Recently, we updated the guidance we published earlier this year, to add more details around what will change when the amended regulations come into force on 28 April 2026.

Having reached this milestone and published our final version of the guidance, we thought it was a great opportunity to look back at the past few years and all the events, work and (many) discussions that have led us to this point.

Partly so you and all others reading this can have a clear idea of how we produced this guidance (transparency is a main feature in the new regulations after all), but also to communicate the number of people and groups that gave their time and effort to this work.

In the beginning

In 2021 we and the MHRA began working together to establish a list of proposed updates to the legislation that we thought would improve research regulation within the UK and enable more high quality research to take place. By early 2022 we had taken these proposed updates to the public and asked for their perspective as part of a public consultation.

After looking through the responses, we then presented the outcomes of all the proposed updates to the government, which published its response in 2023 and confirmed what updates would be made.

This gave us and the MHRA a solid foundation to start the work.

Based on this, we both began drafting updates to the legislative text that would address all the points the government agreed to make. As you may imagine, writing updates to legislation is a delicate and complex process, likely even more so than writing a blog post clearly describing it. To make sure it updated everything we needed and was fit for purpose, this process needed a large number of subject matter experts from both the HRA and MHRA, and legal experts, to discuss and draft the updates.

While this was ongoing we also used the opportunity to organise ourselves internally, ensuring there were several teams each with adequate expertise involved to be able to understand the updates, advise on any points needing input and prepare for the future updates and the production of guidance to accompany it. Things were going smoothly and to plan, which in hindsight is an omen that something unexpected may be approaching.

A general surprise

In the summer of 2024 it was announced that a general election would take place.

When a general election is called, all public organisations (including arm’s length bodies of government departments, like the HRA) enter a pre-election period which means we need to pause some of our work and activities. The reason for this is it could introduce bias into the election period and interfere with a critical democratic process in our country.

Therefore, not wanting to undermine democracy, all work on the clinical trials regulations was ceased until the election was complete. Once all votes had been cast and a new government was elected, we brought the work we had done so far to them for their consideration and judgement. The newly elected government supported the work we had done and told us to get going once again so that the new text could be provided to Parliament and signed into law.

In December 2024 the draft legislation had been completed and was provided to Parliament to be debated and for any questions to be raised. While this was ongoing, and with us now having the preliminarily agreed draft legislation to go off, we began producing guidance that we would publish to explain what was being updated in the regulations.

Creating the guidance

Knowing that the regulations would have a 12-month implementation period (meaning they wouldn’t come into force until 1 year on from when the new regulations were approved) we planned to produce a piece of guidance that would sit on the HRA website explaining what will change when the implementation period ends on 28 April 2026. The MHRA also set out to produce their own guidance explaining what would change.

So this was the beginning of the guidance getting developed. Both we and the MHRA would produce our own guidance (covering our respective remits) but do so in constant communication to ensure the guidance was aligned.

From January to March 2025 the guidance and advice team in the HRA worked with several subject matter experts within the project, from a variety of teams across the HRA (including approvals, policy, communications and engagement) to produce our initial draft guidance. This was successfully completed in March 2025, after which we approached stakeholders from a range of backgrounds (including commercial sponsors, contract research organisations, NHS sites and clinical trial units) for them to raise any queries and give feedback on the draft.

We had more than 800 comments on our draft guidance, which was invaluable in helping us to improve our guidance. The points raised were discussed over the course of a month with more input from our internal subject matter experts and our external partners.

The guidance was fully published in June 2025. However, we didn’t intend to just publish the guidance and assume all was well. Instead we ran a feedback survey that was open to anyone reading the guidance.

In September 2025 when the feedback survey closed, we reviewed all of the comments received (more than 100 this time) and again discussed them with several subject matter experts from the HRA, and the MHRA, to help guide the final update to our guidance.

Back to the present

With that we reach today. Clearly we still have some time until the new regulations come into force and we’re actively working and planning to make sure everyone is supported and has the information they need. However, this post is very much a matter of looking back over the whole journey.

This helps us clarify how we got here but also allows us to take stock of the time and effort that so many have given to it. Not just staff here within the HRA, but our colleagues at the MHRA, the groups we’ve engaged with along the way and everyone who provided feedback during the course of the past 3 years.

This work has had contributions from far too many to list here, in an already longer than usual blog post, but hopefully this shines a light and gives an indication on the work done by so many to get us here.

To everyone involved we thank you deeply and hope we get to work with you all again in future (on whatever future work that may be).