Dame June Raine: How innovations are transforming regulation and speeding new treatments to healthcare
Source: gov.uk (2025-03-30)

As Dame June Raine gets ready to pass the baton on after nearly 40 years at the agency, the last five of which she has been CEO, she reflects on how new innovations are transforming regulation and how honoured she feels to have worked with such inspiring people through a period she has not just lived through but helped to shape.

When I entered the world of regulation in the mid-1980s, approvals for new medicines or the trials investigating them were arduous and subjective, requiring the review of juggernauts of paper files with thousands of graphs and tables of data in each file – not to mention a retentive memory, a very big desk and many painstaking hours of review.

Fast forward to today, and healthcare product regulation is being transformed by technology. Just as Lord Darzi called for a major tilt to technology in the heath service, so MHRA is working to take time out of the development and review process for transformative medicines and MedTech.

For example, new AI tools can reduce the length of time taken to assess vital aspects of clinical trial applications from 3 hours to as few as 35 seconds, without compromising on safety. By rapidly pinpointing common errors in applications made by companies to the regulator, AI has sped up the overall assessment process and is helping to make it consistent and predictable.

The intention of this is not to replace the expertise of our experienced and knowledgeable scientific assessors but rather to give them more time to focus on higher risk analyses and more finely balanced judgements. This will see clinical trials being set up more swiftly, saving companies valuable funds and giving patients quicker access to the potentially life-saving medicines being studied.

Thanks to successful pilots, this AI technology is now coming on stream in regulation, with international approval of the work we are doing at MHRA. It shows how far regulation has come from the days of paper-based assessments, and how exciting regulation is today – and you don’t often hear the words ‘exciting’ and ‘regulation’ in the same sentence.

We’re in a new era of medicine - one defined by technological advancements like AI and genomics, and a focus on meeting the needs of the individual rather than the whole population. A continued challenge for the next decade will be to ensure that regulation doesn’t just keep pace with this innovation but enables it.

That’s why last week saw the launch of our first Centres of Excellence of Regulatory Science and Innovation, two of which are driving forward AI and health technology and one active in improving safety through pharmacogenomics.

As I get ready to pass the CEO baton on after nearly 40 years at the MHRA, the last five of which I have been Chief Executive, I have been reflecting on what has been accomplished during my time holding the reins. My leadership was one dominated by two main events that in many ways came to set the pace and direction of change.

The first of these was EU Exit, which offered new freedom to form novel international partnerships with trusted healthcare agencies both at home and abroad. Our ACCESS consortium of the regulatory agencies of Australia, Canada, Singapore and Switzerland has created an attractive market for innovative industry of close on 160 million people.

The second event was one that few saw coming. The COVID-19 pandemic brought devastation and hardship to many people’s lives. But in 10 months it ushered in the level of innovative change you would expect to see in 10 years. When we announced our world-first approval of the COVID-19 vaccine made by Pfizer and BioNTech, we didn’t cut any corners. We developed innovative approaches to delivering the same high scientific standards and worked hand in hand with NICE and the NHS.

These two seismic events have come to define my leadership, and probably rightly so. But advances in AI and the strides we’ve made towards a more personalised regulatory approach are also vitally important and will set the trajectory for regulation in years to come.

The next few years will be defining ones for medicines regulation. I have absolutely no doubt that the agency I am leaving behind will continue to step up to the job, never losing sight of the paramount importance of patient safety. I feel truly honoured to have worked with inspiring people in a period we have not just lived through but helped to shape.

I look forward to watching – this time from the sidelines with a much warmer cup of tea in hand.