MHRA Chair Professor Anthony Harnden: Bringing our strategy to life – listening, learning, and looking ahead
In the final instalment of our strategy blog series, MHRA Chair Professor Anthony Harnden reflects on the insights shared throughout the series and how innovation and collaboration across the UK are shaping the future of healthcare regulation.
Over the course of this blog series, we have deliberately created space for voices beyond the MHRA to challenge, reflect and help shape our thinking. That has been a critical part of how we have developed our five-year strategy.
The contributions from external experts across academia, industry and the wider health system have been both thoughtful and constructive. They have not simply endorsed our direction, they have pushed us to think differently about what kind of regulator we need to be in the future.
As we bring this series to a close, I want to reflect on what we have heard, and how those insights are shaping our priorities and ambitions.
Several themes have come through strongly across the series. These perspectives are not abstract. They go to the heart of what we must do differently, and better, in the years ahead.
A regulator for all nations
One of the clearest messages, both from contributors to this series and our wider engagement, is that we must truly operate as a regulator for all nations of the UK.
The contributions to this series reveal a rich and varied picture of innovation across the UK. From Scotland’s clinical research infrastructure and Northern Ireland’s distinctive regulatory position and potential to support access to UK and EU markets, to Wales’s connected health and care system, each nation brings distinct strengths and opportunities. Together, these perspectives reinforce a common message: successful regulation must be connected to the systems around it and shaped through genuine partnership. That means strengthening how we work with devolved governments, health systems and regional partners, and ensuring that our regulatory approach reflects different contexts while remaining consistent in its standards.
It also means being more visible and more engaged, so that regulation is not something done “to” the system, but something developed with it.
Patient-centred regulation
The call for flexibility from contributors like Professor Rhodes speaks directly to the need for patient centred regulation.
As innovation accelerates, from advanced therapies to AI-enabled technologies, we must ensure that our frameworks are robust but not rigid. Proportionate regulation is about applying judgement: enabling safe innovation to reach patients more quickly, while maintaining confidence in the system.
This will require us to continue evolving how we assess evidence, how we engage earlier with innovators, and how we balance opportunity with risk.
A world-class safety and surveillance system
The vision set out by Professor Sir Aziz Sheikh reinforces that safety must remain at the core of our mission, but the way we deliver it must evolve.
We have the opportunity to build a truly world class safety and surveillance system, one that uses data more intelligently, links information across sources, and allows earlier identification of risks. This will help us understand more precisely which patient groups may be at greater risk and take earlier, more targeted action.
This is about being proactive, not reactive. It also means communicating emerging safety issues clearly and quickly to patients and healthcare professionals, so they have the information they need to make informed decisions.
Navigating risk and building trust
Sir David Spiegelhalter’s reflections are a reminder that as science becomes more complex, so too does the task of regulation.
In an age of personalised medicine, we must be clearer than ever about how we assess and communicate risk and uncertainty. That includes listening to patients and understanding their “preference zones”, recognising that individuals may make different choices about the risks they are prepared to accept in treating their condition.
Transparency is not simply about publishing decisions; it is about helping people understand them.
Building and maintaining public trust will remain fundamental to our role.
Investing in our people
Delivering all of this depends on the strength of our organisation.
While much of this series has rightly focused on the external environment, there is a consistent message, both implicit and explicit, that our ability to respond depends on our people, culture and capability.
Improving our culture is therefore not a peripheral ambition, it is central to delivery. We need to ensure that our people feel supported, empowered and connected to our purpose.
That means investing in skills, strengthening leadership, and creating an environment where expertise can thrive. A regulator that is agile, confident and outward-looking must be built on a workforce that feels the same way.
Looking ahead
This series has brought together a rich set of perspectives from outside and within the MHRA. It has challenged us, and it has strengthened our thinking.
What emerges clearly is the need for a regulator that is:
- connected across all nations of the UK
- proportionate and enabling in its approach to innovation
- world-class in how it monitors and safeguards patients
- and grounded in a strong, capable and engaged workforce
As we publish our five year strategy, this is not the end of the conversation. It is the point at which we move from reflection to delivery.
We will continue to listen, to learn and to adapt. And we will continue to work with partners across the system to ensure that regulation supports both innovation and the highest standards of safety.
I would like to thank all those who have contributed to this series. Your insights have played an important role in shaping our direction, and they will continue to inform what we do next.