WHO Grants Top-Tier Regulatory Status to Canada, Japan, and UK Agencies

Geneva, 8 August 2025 — The World Health Organization (WHO) has officially recognized the national regulatory authorities of Canada, Japan, and the United Kingdom as WHO-Listed Authorities (WLAs)—a distinction awarded to agencies that meet the highest global standards in regulating medical products.

The designation applies to Health Canada, Japan’s Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). With these additions, the WHO’s roster of WLAs now counts 39 agencies worldwide, reflecting a growing network of trusted regulators whose work is relied upon internationally to ensure the safety, efficacy, and quality of medicines, vaccines, and other health technologies.

Scope Expansion for South Korea’s Regulator

The announcement also confirmed that 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 successfully expanded its listing scope to cover all regulatory functions. This milestone further strengthens the region’s role in global health security and pharmaceutical oversight.

What WLA Status Means

A WHO-Listed Authority designation signifies that an agency has undergone rigorous performance evaluation, using WHO’s globally recognized benchmarking and assessment tools. These evaluations examine regulatory governance, oversight capacity, market surveillance, licensing processes, pharmacovigilance, and ability to respond to health emergencies.

The process includes peer review and scrutiny by the Technical Advisory Group on WHO-Listed Authorities (TAG-WLA), which met in June 2025 to finalize the latest listings. WLA status assures other countries and international procurement bodies that the authority’s approvals and monitoring meet world-class standards, reducing duplication and accelerating access to essential medical products—particularly in low- and middle-income countries (LMICs).

Moving Beyond the SRA Model

Canada, Japan, and the UK’s regulators were previously recognized as Stringent Regulatory Authorities (SRAs)—a system long used by global health agencies to guide procurement decisions. The WLA initiative, launched in 2022, replaces the SRA model with a more transparent, evidence-based, and globally applicable framework. This transition preserves continuity in procurement processes while expanding participation beyond the original group of SRAs, which largely represented high-income countries.

Addressing Global Regulatory Gaps

WHO estimates that around 70% of countries still face serious weaknesses in their medical product regulatory systems. This can result in delays in approving life-saving medicines, inadequate post-market surveillance, and vulnerability to substandard or falsified products.

By designating WLAs, WHO promotes regulatory convergence and harmonization—encouraging LMIC regulators to rely on the decisions and evaluations of trusted agencies. This principle of reliance, as described by Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, is central to speeding up access while making efficient use of limited resources.

Strengthening Preparedness and Equity

WHO Director-General Dr Tedros Adhanom Ghebreyesus hailed the latest designations as a “critical contribution to global public health,” noting that strong and trusted regulators are essential for ensuring access to safe, effective, and high-quality medical products everywhere. In a world where health threats know no borders—from pandemics to the spread of counterfeit medicines—WLAs serve as a first line of defense against risks to patient safety.

The WLA framework not only improves routine regulatory efficiency but also strengthens preparedness for public health emergencies by enabling rapid, internationally trusted approvals of vaccines and treatments.

The Road Ahead

With the number of WLAs expanding, WHO aims to further embed reliance and collaborative decision-making into the global health architecture. This includes closer alignment with the WHO Prequalification Programme, capacity-building for LMIC regulators, and expanded recognition of authorities beyond traditional high-income contexts.

The ultimate goal, WHO officials stress, is equitable, timely, and universal access to quality-assured medical products—whether for routine care or emergency response—by leveraging the collective expertise and credibility of the world’s top regulators.