WHO Designates Canada, Japan, and UK as WHO-Listed Authorities, Strengthening Global Access to Safe Medical Products

    New Delhi, 15 August 2025: The World Health Organization (WHO) has officially 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). The recognition affirms these national regulatory bodies meet the highest international standards for overseeing medical products.

    The latest designations expand the growing network of WLAs to 39 agencies worldwide, strengthening global efforts to ensure faster and broader access to quality-assured medicines and vaccines, especially in low- and middle-income countries (LMICs).

    “These authorities’ designation as WHO-Listed Authorities reflects their deep commitment to regulatory excellence,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “Strong and trusted regulators help ensure that people everywhere have access to safe, effective, and high-quality medical products.”

    Also receiving expanded recognition is the Republic of Korea’s Ministry of Food and Drug Safety (MFDS). Already among the first to complete the WLA assessment for both medicines and vaccines in 2023, MFDS now has its listing extended to cover all regulatory functions.

    The WLA framework was launched in 2022 to replace the previous Stringent Regulatory Authority (SRA) model. It provides a transparent and evidence-based pathway for recognizing national regulatory authorities that demonstrate high performance and capacity. Canada, Japan, and the UK were all previously recognized as SRAs. Their new designation ensures continuity and strengthens international trust in their regulatory decisions.

    According to WHO, nearly 70% of countries still struggle with weak regulatory systems. WLAs play a critical role in promoting regulatory convergence, harmonization, and collaboration. They enable other nations, particularly LMICs, and global health partners such as the WHO Prequalification Programme, to rely on their assessments to accelerate access to life-saving medical products.

    “The principle of reliance is central to WHO’s regulatory strategy,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. “WHO-Listed Authorities promote trust, transparency, and faster access to quality-assured medical products.”

    Evaluations for WLA designation are conducted through WHO’s globally recognized benchmarking tools and are reviewed by the Technical Advisory Group on WLAs, which most recently convened in June 2025.

    In a global health landscape where threats like substandard or falsified products cross borders, the WLA initiative is seen as essential to ensuring equity, preparedness, and timely access to trusted medical interventions.