Geneva: The World Health Organization (WHO) has designated Health Canada, Japan’s Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) as WHO-Listed Authorities (WLAs).
This status is awarded to national regulatory agencies that meet the highest international standards for the oversight of medical products.
With these new additions, the number of WHO-Listed Authorities has grown to 39 globally. These designations support faster, broader access to quality-assured medical products, especially in low- and middle-income countries (LMICs).
In a related development, the Republic of Korea’s Ministry of Food and Drug Safety (MFDS)—one of the first regulators to complete WLA assessments for both medicines and vaccines in October 2023—has had its scope expanded 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.”
Currently, around 70% of countries still face significant challenges due to weak or insufficient regulatory systems. The WLA framework promotes regulatory convergence, harmonization, and international collaboration—allowing WHO’s Prequalification Programme and regulatory bodies in LMICs to rely on the expertise and decisions of these trusted agencies. This enhances the efficient use of limited resources and improves access to life-saving medical products worldwide.
“The principle of reliance is central to WHO’s approach to strengthening regulatory systems,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. “WHO-Listed Authorities are key enablers of trust, transparency, and faster access to quality-assured medical products, particularly in LMICs.”
In a world where substandard and falsified medical products pose global threats, WLAs also play a vital role in preparedness and health equity—helping ensure timely access to life-saving medicines and vaccines.
These latest designations follow a rigorous evaluation process using WHO’s globally recognized benchmarking tools. The results were reviewed by the Technical Advisory Group on WLAs (TAG-WLA), which met in June 2025.
Canada, Japan, and the UK’s regulators were previously recognized as Stringent Regulatory Authorities (SRAs). Their new designation under the WLA framework marks a transition from the former SRA system while maintaining continuity in global procurement and regulatory processes.
Launched in 2022, the WLA initiative replaces the SRA model with a transparent, evidence-based framework for recognizing regulatory authorities. It aims to promote greater collaboration and reliance among countries, accelerating access to safe, effective, and quality-assured medical products for all.
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