New UK clinical trials regulations take effect on 28 April 2026
Short answer
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 came into force in the UK on 28 April 2026. They speed up combined MHRA and ethics review, add a notification route for lower-risk trials and make trial registration and results publication legal duties. Sponsors and CROs sourcing comparators from India should expect shorter start-up windows.
Key takeaways
- The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025 No. 538, came into force on 28 April 2026.
- The Health Research Authority reports combined MHRA and ethics review averaging 41 days and set-up times falling from 169 to 122 days.
- Lower-risk trials can use a notifiable trial route, and eligible substantial modifications are approved automatically unless concerns are raised within 14 calendar days.
- Trial registration and publication of summary results become legal requirements.
- MHRA guidance keeps final batch release and QP certification of investigational products with the MIA (IMP) holder named in the application.
What changed
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, SI 2025 No. 538, came into force on 28 April 2026, according to the government's clinical trials guidance collection. They amend the UK framework for clinical trials of investigational medicinal products (CTIMPs).
The Health Research Authority summarised the main changes on the day they took effect:
- a combined MHRA and ethics review that it says now averages 41 days,
- set-up times for studies through combined review falling from 169 days to 122 days,
- a notifiable trial route and a faster path for lower-risk trials,
- automatic approval of eligible substantial modifications unless concerns are raised within 14 calendar days,
- faster assessment of first-in-human trials, and use of early overseas safety data and computer modelling where they meet UK standards,
- trial registration and publication of summary results as legal requirements for the first time.
The MHRA's guidance on good manufacturing practice for investigational products, updated on 28 April 2026, says sites making investigational products need an MIA (IMP) licence. The sponsor's application must name the MIA (IMP) facility doing final batch release and QP certification. It also says separate Great Britain guidance on GMP for investigational products is still to come.
Who it affects
- Sponsors and CROs running interventional medicine trials in the UK.
- Suppliers of comparators, co-medications and other trial products, including Indian manufacturers and exporters.
- MIA (IMP) holders and qualified persons who certify trial supplies for UK sites.
What it means for buyers
Faster approvals shorten the gap between approval and first patient. Comparator sourcing, which often depends on a specific batch, expiry and pack, needs to start earlier and run alongside the application rather than after it.
The guidance read for this update does not address importing comparators or other trial products from outside the UK. Because the application names the MIA (IMP) site responsible for release and QP certification, that site's view of documents from an Indian supplier matters. These usually include the certificate of analysis, GMP evidence and a clear chain of custody. Confirm with the sponsor's release site and the MHRA before shipment.
What to do now
- Start comparator sourcing when the trial application is filed, not when it is approved.
- Ask the MIA (IMP) holder which documents it needs from the Indian manufacturer or exporter for QP certification.
- Agree the batch, expiry date and labelling approach early, using the MHRA labelling guidance in the same collection.
- For products not approved in India, allow for Indian export approvals in the timeline.
For sourcing steps, see comparator sourcing for clinical trials and the United Kingdom import guide.
This page explains how regulatory routes work. It is not legal or medical advice. Confirm current requirements with the regulator or a local agent before goods ship.
Questions and answers
Do the new UK rules change how comparators are imported from India?
The guidance read for this update does not address imports of comparators or other investigational products from outside the UK. It does say the application names the MIA (IMP) site responsible for final batch release and QP certification, so agree the import and release route with that site before ordering.
Which trials do the regulations cover?
They apply to clinical trials of investigational medicinal products in the UK. Lower-risk trials may qualify for the notifiable trial route, while other trials go through the combined MHRA and ethics review.
References
- 1.GOV.UK, Clinical trials for medicines collection, including the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
- 2.Health Research Authority, New UK clinical trials regulations now in force (28 April 2026)
- 3.MHRA, Clinical trials for medicines, good manufacturing practice and radiopharmaceutical investigational medicinal products
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