MHRA set to become global leader in risk-proportionate regulation

Chris Whitehouse, a political consultant and expert on medical technology policy and regulation at Whitehouse Communications, an advisor to MedTech suppliers, chair of the Urology Trade Association, and governor of the Anscombe Bioethics Centre, highlights the UK regulator’s strategic priorities for MedTech regulation.

UK MHRA (Medicines and Healthcare products Regulatory Agency) CEO puts safety, accelerated access and innovation at the centre of agency’s refreshed strategic direction.

Speaking at major industry event in Washington DC, DIA Global, the Agency’s CEO, Lawrence Tallon, identified its strategic aims as:  

• Patient and public safety: To build a world-class safety and surveillance system enabled by comprehensive real-world data for the protection of patients and the public. 
• Accelerated access: To accelerate access to new medicines, medical products and technologies with rapid, efficient decisions on clinical trials and core licensing.
• 10X innovation: Driving up the MHRA’s contribution to UK life sciences for the benefit of the public, the NHS and economic growth.  

Julian Beach, MHRA Interim Director of Healthcare Quality and Access said: “Our latest performance data shows our approval decisions are made on time, every time. 

“Our focus now is on capitalising on our national decision-making ability with new guidance that will enable innovation in new and existing areas, and enhancing our collaborative working with NICE to provide a new joined-up licensing and guidance pathway.  

“Critical to this is working with international partners to establish the best outcomes for patients in the UK.” 

James Pound, Interim Executive Director of Innovation and Compliance said: “I see three key pillars for success in this next chapter.   

“We must continue to cement the UK as a research powerhouse through our world-class infrastructure, research base and rapid approvals.  

“We must move upstream – positioning the MHRA as an engine of innovation to help get cutting-edge new treatments and technologies to patients and the NHS faster.  

“And we must turbocharge the AI revolution in healthcare, in medical devices and in driving efficiencies in our own risk-proportionate processes.” 

The Author used AI in preparing this article, comments upon or questions about which can be addressed to [email protected].

Related