The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has taken a major step in reshaping its operations after Brexit. The UK drug regulator outsources nearly 40% of approval applications to trusted international agencies. This frees up resources to focus on cutting-edge medical innovations.
Since 2024, the MHRA has allowed companies to use an “international recognition procedure” for drugs and devices already approved by regulators in the EU, US, or Australia. This streamlined process now covers 37% of all applications. As a result, it reduces redundancy and speeds up market access.
MHRA Chief Executive Lawrence Tallon, who took charge in April, emphasized the agency’s new direction. Instead of duplicating approvals, the UK drug regulator outsources routine assessments. This allows them to prioritize areas where Britain excels—like AI-driven healthcare and advanced cell and gene therapies.
“We aspire to move faster than other countries and set global standards,” Tallon told the Financial Times.
After Brexit, the MHRA faced staffing shortages and delays, causing the UK to lose ground in clinical trial hosting. However, Tallon claims the agency has now cleared its backlog and meets all approval targets. Clinical trial reviews, which once took 60 days, now wrap up in just 40.
The UK government’s new 10-year NHS plan aims to further boost competitiveness. It promises to slash clinical trial setup time from 250 days to 150 by March 2026. This will make Britain more attractive to pharmaceutical firms.
Tallon sees AI as a key area for the MHRA to lead globally. Unlike traditional drugs, AI tools evolve post-approval, requiring dynamic oversight. The agency is forming an expert advisory board, including patient advocates, to guide AI regulation.
Despite progress, critics argue that NHS drug pricing—not regulation—remains the biggest hurdle for life sciences growth. Yet, with the UK drug regulator outsourcing routine work and refocusing on innovation, the agency hopes to reclaim its reputation. Indeed, it aspires to be a global leader in medical advancement.
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