New Year's regulations - What does your business need to know for 2026?
Now that the start of the festive period approaches, many of us are making personal New Year's resolutions and goals for the next year. This is also a great time to pause and consider the upcoming regulatory changes for the sector, and the steps your business can take to be in the best position for 2026.
Introduction of new clinical trials regulations
The Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) have worked together to significantly update the UK's clinical trial regulations. The updated regulations aim to accelerate approvals and provide a proportionate and flexible framework which will support research and innovation in the UK.
When is this coming in?
The revised legislation will be effective from 28 April 2026. Please be aware that you may have seen that the amended regulations were due to come into force on 10 April - this date was later revised due to
a technical issue on the final processing of the Statutory Instrument.
What should your business be doing to prepare?
- The MHRA has published draft guidance on its Clinical Trials Hub. The regulator has said that only minimal adjustments will be made prior to go live, so it is a good idea to have a read through this and start making plans for implementing changes.
- Review the guidance for Good Clinical Practice (GCP) when this comes out - the MHRA has reported that this will be published in January 2026.
We will be publishing a detailed article on the legislative changes at the start of next year. So please keep an eye on the VWV website for this.
Rare diseases regulatory reform
Supporting the government's ambitions around genomics (as set out in its Life Sciences Sector Plan), the MHRA has recently published a paper detailing its commitment to major regulatory reform for rare disease therapies. The MHRA has emphasised that the new framework will be quick, flexible and proportionate - with ideas such as the possibility of preliminary approvals issued on limited, but appropriate, evidence.
We can expect a draft of the framework to be available in Spring 2026, with a public consultation to then follow.
Next steps for medical devices
As discussed in our previous article, the MHRA is busy with reforms for medical devices. The next major step is the introduction of new regulations for 'pre-market' requirements. Before being introduced to parliament, the new regulations are required to be published on the World Trade Organisation's website - which is expected to take place soon at the time of writing.
In the new legislation, the MHRA plans to introduce amended conformity assessment routes for IVD devices to create a more risk proportionate system. Like with the new clinical trials regulations and the proposed rare diseases pathway, the MHRA has emphasised that is committed to being flexible in its approach and reducing regulatory burdens where safe and appropriate to support innovative approaches to healthcare in line with the government's Life Sciences Sector Plan.
What are some good New Year's resolutions for your business to prepare for regulatory change?
- Be aware of updates and new guidance
During this period of fast-paced change, it is important to be aware of regulatory updates and take early preparatory steps. Develop a system for keeping on top of news. The MHRA has recently been more active with its blogs - so keep an eye on that section of their website. You can also sign up for VWV's Pharmaceuticals and Life Sciences Law Brief. - Review your agreements
June saw new post-market surveillance requirements brought in by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. Manufacturers should review their agreements with distributors to make sure they contain appropriate provisions to enable compliance with their investigation and reporting obligations.
As a general point, the start of a New Year is a good time to make sure your standard terms and conditions and template agreements are up-to-date and in good order. Please reach out to a member of VWV if you want our support with this.
From everyone at VWV, we wish you a happy festive period!
If you have any thoughts about how the upcoming regulatory changes may affect businesses, or if you need any support understanding the changes, please contact Emily Dyer in VWV's Pharmaceuticals and Life Sciences team.
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