MHRA gains WHO-Listed Authority status in milestone for UK regulation and global health

The Medicines and Healthcare products Regulatory Agency (MHRA) has been designated as a World Health Organization (WHO)-Listed Authority, joining a network of trusted medicines regulators whose work supports faster access to safe and effective medical products worldwide. The WHO announced the recognition on 8 August alongside the designation of Health Canada and Japan’s Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency, who received the same status on 7 August.

The designation affirms the MHRA’s compliance with rigorous, evidence-based international standards for the regulation of medicines and medical devices. It replaces the previous ‘Stringent Regulatory Authority’ classification with a transparent, modular framework that allows WHO to recognise a national or regional authority for specific regulatory functions or product categories, such as clinical trial oversight or vaccines, according to demonstrated capability.

A WHO-Listed Authority must first achieve at least Maturity Level 3 under the WHO Global Benchmarking Tool, showing that it has adequate regulatory infrastructure. It must then undergo a performance evaluation to confirm consistent delivery of high-quality regulatory outputs. This listing is now valid for five years, subject to ongoing monitoring and compliance with reporting requirements.

“These designations are a proud moment for the MHRA and for the UK,” said Lawrence Tallon, the chief executive of the MHRA.

“They reflect our unwavering commitment to regulatory excellence, innovation, and global collaboration.

“As a WHO-Listed Authority, we stand ready to support faster access to life-saving treatments worldwide, while continuing to uphold the highest standards of safety and efficacy,” he said.

The MHRA’s listing aligns with the UK Government’s Life Sciences Sector Plan, which seeks to position the country as a global centre for innovation, and with the 10-Year Health Plan for England, which aims to shift healthcare from hospital to community, analogue to digital, and emphasise prevention to help diminish the burden of treatment.

The MHRA’s designation adds to a global cohort of around 39 WHO-Listed Authorities, reinforcing international cooperation to safeguard public health.

The WHO framework aims to strengthen global regulatory systems, foster convergence, and enable reliance on trusted decisions. This aims to reduce duplication, optimise the use of resources and accelerate availability of quality-assured products, particularly in low- and middle-income countries.