The World Health Organization (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) in the United Kingdom as WHO-Listed Authorities (WLAs), a status granted to national agencies that meet the highest international medical product regulatory standards.

With these latest designations, WHO expands the growing WLA list to include 39 agencies worldwide. The expanded list will help support 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 had its listing scope successfully expanded, now covering all regulatory functions.

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

About 70% of countries worldwide still face significant challenges due to weak or inadequate regulatory systems for evaluating and authorizing medical products. The WLA framework promotes regulatory convergence, harmonization and international collaboration, allowing WHO Prequalification Programme and regulatory authorities, especially those in LMICs, to rely on the trusted work and decisions of designated agencies. This collaboration supports efficient use of limited resources, enabling better and faster access to quality-assured life-saving medical products to 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,” stated 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 carried out by WHO using its globally recognized benchmarking and assessment tools. These evaluations were reviewed by the Technical Advisory Group on WLAs (TAG-WLA), which convened in June.

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

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.