Global Medical Product Regulators Network Development
WHO Designates Canada, UK, and Japan as World Listing of Authorities for Medical Products
The World Health Organization (WHO) has officially designated Health Canada, JapanS Ministry of Health, Labor and Well-Being / Pharmaceuticals and Medical Devices Agency (MHLW / PMDA), and the Medicines and Health Products Regulatory Agency (MHRA) of the United Kingdom as part of the WHO’s World Listing of Authorities (WLA) for high-performing regulatory authorities in medical products.
This expansion brings the total number of agencies on the WLA to 39 globally, bolstering efforts to accelerate access to quality-assured medical products, especially in low- and middle-income countries (LMICs). Additionally, the Republic of Korea’s Ministry of Food and Drug Safety (MFDS) – a pioneer in WLA assessment, initially recognized for medicines and vaccines in October 2023 – has extended its listing to encompass all regulatory functions.
“This recognition reflects the deep commitment of these authorities to regulatory excellence,” stated Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. “Their designation as authorities listed by the WHO not only testifies to their robust regulatory systems, but also a critical contribution to global public health. Solid and reliable regulators help ensure that people around the world have access to safe, efficient and high quality medical products.”
Currently, approximately 70% of countries worldwide grapple with challenges stemming from weak or inadequate regulatory systems for evaluating and approving medical products. The WLA framework actively promotes regulatory convergence, harmonization, and international collaboration. This allows regulatory authorities, especially those in LMICs, to leverage the expertise and decisions of designated agencies, optimizing resource allocation and expediting access to life-saving medical products for millions.
Dr. Yukiko Nakatani, WHO Deputy Director-general for Health Systems, Access and Data, emphasized the core principle driving this initiative: “The principle of reliance is at the heart of the WHO’s approach to strengthening regulatory systems and a cornerstone for effective, efficient and intelligent regulatory oversight of medical products.” she continued, “The authorities listed by the WHO are key catalysts to promote confidence, transparency and faster access to quality-assured medical products, especially in low and intermediate income countries.”
In an increasingly interconnected world, where health threats – including substandard and falsified medical products – transcend borders, the WLA also serves as a crucial pillar for preparedness and equity, ensuring wider, faster, and more effective availability of essential medicines.
The designations follow a rigorous evaluation process conducted by the WHO, utilizing comparative analysis and globally recognized assessment tools.These evaluations were reviewed by the Technical Advisory group on WLA (TAG-WLA) during its June 2025 meeting.
Canada, Japan, and the United Kingdom’s regulatory authorities were previously recognized as Strict Regulatory Authorities (SRAs). Their transition to WLA status represents a notable evolution beyond the former SRA system, while maintaining continuity and stability in the global supply chain of quality medical products.
Launched in 2022 as a replacement for the SRA model, the WLA initiative provides a obvious, evidence-based pathway for global recognition of regulatory authorities, fostering regulatory convergence and reliance. It builds upon decades of WHO leadership in facilitating international collaboration on medical product regulation,ultimately accelerating access to safe,effective,and quality medical products worldwide.