The World Health Organisation (WHO) has officially designated Health Canada, the Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA) of Japan, and the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom as WHO-Listed Authorities (WLAs), a status granted to national authorities that meet the highest international regulatory standards for medical products.

 

With these latest designations, the WHO expands the growing list of WLAs, now involving 39 agencies worldwide, supporting faster and broader access to quality-assured medical products, particularly in low- and middle-income countries (LMICs).

 

In addition, the Republic of Korea’s Ministry of Food and Drug Safety (MFDS) – one of the first regulatory authorities to complete the WLA assessment for both medicines and vaccines in October 2023 – has successfully expanded its listing scope to cover all regulatory functions.

 

“This recognition reflects the deep commitment of these authorities to regulatory excellence,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. “Their designation as WHO-Listed Authorities is not only a testament to their robust regulatory systems but also a critical contribution to global public health. Strong and trusted regulators help ensure that people everywhere have access to safe, effective, and high-quality medical products.”

 

Around 70% of countries worldwide still face significant challenges due to weak or inadequate regulatory systems for evaluating and authorising medical products. The WLA framework promotes regulatory convergence, harmonisation and international collaboration, allowing the WHO Prequalification Programme and regulatory authorities, especially those in LMICs, to rely on the trusted work and decisions of designated agencies. This collaboration supports the efficient use of limited resources, enabling better and faster access to quality-assured, life-saving medical products for millions more people.

 

“The principle of reliance is central to WHO’s approach to regulatory systems strengthening and a cornerstone for effective, efficient and smart regulatory oversight of medical products,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. “WHO-Listed Authorities are key enablers in promoting trust, transparency, and faster access to quality-assured medical products, especially in low- and middle-income countries.”

 

In a world where health threats, including substandard and falsified medical products, know no borders, WLAs also serve as critical pillars of preparedness and equity, making life-saving products available more broadly, rapidly and efficiently.

 

The designations follow a rigorous performance evaluation process conducted by the WHO, utilising its globally recognised benchmarking and assessment tools. The Technical Advisory Group (TAG) reviewed these evaluations on Workload Allocation (TAG-WLA), which convened in June 2025.

 

Canada, Japan and the UK’s regulatory authorities were previously recognised as Stringent Regulatory Authorities (SRAs). Their designation under the WLA framework marks a significant step in transitioning beyond the old SRA system, while ensuring continuity and stability in the global procurement processes of quality-assured medical products.

 

(Source: WHO) 

Launched in 2022 to replace the previous SRA model, the WLA initiative provides a transparent and evidence-based pathway for global recognition of regulatory authorities to facilitate regulatory convergence and reliance. It builds on decades of WHO leadership to help countries work together more closely on regulating medical products, speeding up access to safe, effective and quality-assured medical products for people around the world.