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New UK clinical trials regulations signed into law – implementation period begins
The laws which regulate the way clinical trials are carried out in the UK are changing.
On Thursday 10 April, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 was formally signed into law by Wes Streeting MP, Secretary of State for Health and Social Care.
The 12-month implementation period for the amended regulations has now begun and will now come into force as of 10 April 2026.
We are now focusing on supporting stakeholders with a smooth transition over the next 12-months.
This will include publishing new guidance to accompany the regulations (see more on this below), as well as training events and opportunities to have your say on how new transparency requirements are introduced.
Further updates and opportunities to get involved will be shared over the coming months.
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Share your feedback on draft guidance to support the updated Clinical Trial regulations
We will publish our guidance to accompany the amended Clinical Trial regulations in May.
The guidance explains what will change in terms of processes, legal requirements and expectations to help researchers and sponsors prepare for when the regulations come into force in April 2026.
We are now looking for feedback to ensure the final guidance is clear and easy to understand what you need to do.
If you would like to be involved in reviewing the draft guidance before it is published in May, you can download a copy of the draft guidance and complete an online survey.
You don’t have to share feedback on every section of the draft guidance, just skip to the relevant sections in the survey and add your comments.
The deadline for sharing your feedback is 5pm on Wednesday 23 April 2025.
If you have any questions or would like to access the draft guidance in another format please email engagement.team@hra.nhs.uk
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Share your feedback
To help us make sure we’re sharing the right information in these updates, please complete our short two question survey.
If there’s anything you would like to hear about in future updates, please let us know by emailing communications@hra.nhs.uk
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