As we start a new year, it is time for us to reflect and look back on 2024’s achievements and at areas where further improvement can be made.
The past year has been particularly eventful as the new government brought fresh opportunities for the Medicines and Healthcare products Regulatory Agency (MHRA), including the chance to help shape the ‘Ten-year health plan’ and contribute to the evolving work of the Regulatory Innovation Office, which launched in October 2024 and sits within the Department for Science, Innovation and Technology.
Which achievements mark out 2024 as a landmark year? To ensure that regulation evolves with science and technology, the MHRA has overhauled the regulations for clinical trials and started reforming the medical devices framework.
We have launched an Innovative Devices Access Pathway pilot programme, developed to attract groundbreaking medical technology, including a blood-based biomarker test for Alzheimer’s disease and a liver cancer treatment that uses focused ultrasound. We have also refreshed the Innovative Licensing and Access Pathway to focus on transformative products.
As a crucial part of the regulatory reform agenda, we have announced a world-first framework for the manufacture of innovative medicines at or close to where a patient receives care. Pharmacists will play a vital role in this by ensuring the safe and effective manufacture of medicines in hospitals, community settings, or even at home.
Constant improvement
Where must we continuously strive to improve? Our services to developers of medicines and medical devices have been a focus throughout the year. In November 2024, the MHRA reached a significant milestone in eliminating a backlog of 1,167 national marketing authorisation applications, as estimated in January 2024. We achieved this with a relentless focus on improving efficiency while maintaining the MHRA’s hallmark rigorous scientific standards.
Our new regulatory framework for clinical trials moves away from a ‘one-size-fits-all’ regulatory approach to a more flexible and risk-proportionate one
The good news is that we are now on track with all licensing applications received since 1 September 2024 to meet our commitment to conclude assessments within expected timeframes, providing consistency of service for applicants.
However, we need to go further. Latest performance data show that we continue to make significant steps towards assessing applications for all medicines within statutory timescales following changes to our established medicines marketing authorisation procedures, which took effect on 1 March 2024.
As for the start of the product ‘lifecycle’, the MHRA has consistently met assessment timelines for clinical trials for more than 12 months and has recorded a welcome uptick in applications. In November 2024, the performance for combined review approval within 60 days (MHRA and the Health Research Authority) was 98% for all clinical trials — within the timeframe recommended by the O’Shaughnessy Review, which was published in May 2023.
The improvements that helped us clear a backlog of 966 clinical trial applications between July and September 2023 have been embedded into our standard working practice, and we continue to deliver enhancements to ensure that the UK is one of the best places to conduct research, for both patients and innovators.
New regulatory framework
The MHRA is confident that the new regulatory framework for clinical trials will make the UK a destination for conducting trials that are innovative, inclusive and international, and help to get life-changing medicines to the people who need them sooner. The framework moves away from a ‘one-size-fits-all’ regulatory approach to a more flexible and risk-proportionate one — one that sees duplicative requirements removed and processes streamlined without compromising on patient safety.
An important part of this new framework will be taking trials closer to patients. We know how important it is that clinical trials reflect the populations they are designed to treat, because medicines can affect people differently. Taking trials closer to patients will make this vital inclusivity easier, and it is exciting to see pharmacy stepping into this new environment.
At the start of the new year, we know there is still work to do, which is why our foot will remain firmly on the accelerator. Optimising our performance and cementing the MHRA as an agile and world-leading regulator will remain a priority in 2025, for the benefit of all those who use medicines and medical devices, from both the patient and the healthcare service’s perspective. In doing so, our partnership with the pharmacy profession will be more important than ever.
June Raine is the chief executive of the Medicines and Healthcare products Regulatory Agency
