We are now setting out the next phase of clinical trial reforms for 2026, aimed at helping patients access new cutting-edge treatments more quickly and boosting the UK’s competitiveness for global clinical research. 

The UK is ramping up efforts to become a global first choice for clinical trials, as new figures published on 13 January, show a sharp rise in activity in 2025, and changes coming this year – including a fast-track route – that will help companies get studies up and running more quickly, so patients can benefit from new treatments sooner. 

We are proud to announce that we have formally begun our tenure year as Chair of the Access Consortium for 2026. This marks a new phase of international regulatory collaboration aimed at strengthening patient access to safe, effective medicines. 

The Access Consortium — comprising regulatory authorities from the UK, Australia, Canada, Singapore and Switzerland — work together to streamline regulatory processes, support innovation and improve global public health outcomes. 

We have recently launched a pilot programme offering clinical investigation application fee waivers to micro and small UK enterprises. This initiative aims to test how removing the Clinical Investigation fee can positively impact micro and smaller businesses, helping to encourage growth and innovation, and in turn supporting patient access to innovative medical devices. Waivers are limited during this pilot phase, so we encourage you to apply as soon as possible. Applications close on 31 March 2026. Find out more and apply.

Following the publication of a new systematic review and meta-analysis in The Lancet Obstetrics, Gynaecology, & Women’s Health this month.  No evidence was found to conclude that paracetamol use during pregnancy increases the risk of autism spectrum disorder, ADHD or intellectual disability among children. We have reaffirmed that paracetamol continues to be the safest option for managing pain and fever during pregnancy.

Updated safety measures will strengthen our ability to monitor safe prescribing while supporting patient access to treatment across all age groups. These changes aim to maintain robust oversight of safety whilst supporting smoother access to treatment for young people with severe acne.

The updated approach follows independent advice from the Commission of Human Medicines (CHM) which carried out a review of the impact of the existing safety measures for the prescribing of isotretinoin.  

We have published new online learning resources to help health and social care professionals and the public make informed choices about digital tools for mental health support.

The resources were developed with NHS England’s MindEd Technology Enhanced Learning programme and include:

• Resources for the general public
• Resources for health, social care, and education professionals – for teachers, nurses, GPs and mental health practitioners.

With digital tools such as symptom-tracking apps and virtual reality therapies now widely available, the new learning resources help raise awareness about tools which claim to diagnose, treat or manage a mental health condition. These are classed as medical devices and must display a CE or UKCA mark. They must also meet safety standards and be registered on the MHRA’s online public register. Safety concerns can be reported to the MHRA Yellow Card scheme.

As MHRA Chair Professor Anthony Harnden explains: “This guidance supports better conversations between clinicians and patients and helps everyone ask the right questions about whether a tool is right for them.”

Nearly 20 million doses of potentially dangerous medicines were prevented from reaching the public.

Working with law enforcement partners, almost 20 million doses of illegally traded medicines were seized, with a potential street value of nearly £45 million, during 2025. 

As part of a crackdown on criminal profits, our financial investigators also denied criminals access to more than £2.1 million in assets linked to the illegal trade in medicines.