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Geneva, Switzerland – In a strategic move to strengthen global public health, the World Health Organization (WHO) has officially recognized the regulatory systems of Health Canada, Japan’s Ministry of Health, Labor 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 designation signifies that these national agencies meet the highest international benchmarks for regulating medical products, paving the way for faster and more reliable access to essential medicines worldwide.
The WLA initiative, launched in 2022, represents a meaningful evolution from the previous Stringent Regulatory Authorities (SRA) model. It provides a obvious, evidence-based framework for recognizing regulatory bodies that demonstrate robust oversight of medical products. This framework is designed to promote regulatory convergence, harmonization, and international collaboration, ultimately ensuring that quality-assured medical products reach those who need them most, especially in low- and middle-income countries (LMICs). Learn more about the WLA framework.
With these latest additions, the network of WLAs now encompasses 39 agencies globally. The Republic of korea’s Ministry of Food and Drug Safety (MFDS) also recently expanded its listing scope to cover all regulatory functions, having initially completed the WLA assessment for both medicines and vaccines in October 2023.
A Commitment to Regulatory Excellence
“This recognition reflects the deep commitment of these authorities to regulatory excellence,” stated 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.”
Did You No? Approximately 70 percent of countries worldwide grapple with challenges stemming from weak or inadequate regulatory systems for evaluating and authorizing medical products.
The Impact of WLA Designation
The WLA framework enables the WHO Prequalification Program and regulatory authorities – especially those in LMICs – to leverage the trusted work and decisions of designated agencies. This collaborative approach optimizes resource allocation, accelerating access to life-saving, quality-assured medical products for millions. The principle of ‘reliance’ is central to WHO’s strategy for strengthening regulatory systems, fostering efficient and smart oversight of medical products.
Dr. Yukiko Nakatani, WHO Assistant director-General for Health systems, Access and Data, emphasized, “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 an era marked by increasing health threats, including the proliferation of substandard and falsified medical products, WLAs serve as vital pillars of preparedness and equity. They facilitate the broader, more rapid, and efficient availability of life-saving treatments.
Rigorous Evaluation Process
The designations are the result of a comprehensive performance evaluation conducted by the WHO, utilizing globally recognized benchmarking and assessment tools. These evaluations underwent review by the Technical Advisory Group on WLAs (TAG-WLA) during its June 2025 meeting. Previously recognized as Stringent Regulatory Authorities (SRAs), Canada, Japan, and the UK’s transition to WLA status represents a significant step forward, ensuring continuity and stability in global procurement processes.
| authority | Country | Designation Date | Scope |
|---|---|---|---|
| Health Canada | Canada | August 2025 | All medical products |
| MHLW/PMDA | Japan | August 2025 | All medical products |
| MHRA | United Kingdom | august 2025 | All medical products |
| MFDS | Republic of Korea | october 2023 (Expanded August 2025) | All regulatory functions |
Pro Tip: Understanding the role of regulatory authorities like WLAs is crucial for ensuring the safety and efficacy of the medications and vaccines you and your family rely on.
What challenges do countries with weaker regulatory systems face in accessing essential medicines? How can international collaboration further strengthen global health security?
Looking Ahead: The Future of Global Medical Product Regulation
The WLA initiative is expected to continue expanding, with more regulatory authorities undergoing assessment. this ongoing process will further strengthen the global network of trusted regulators, enhancing access to quality-assured medical products and bolstering public health worldwide. The focus will likely shift towards supporting LMICs in building their own robust regulatory systems, fostering self-reliance and sustainable access to essential medicines. The WHO’s commitment to regulatory strengthening aligns with broader global health security efforts, recognizing that a strong regulatory framework is fundamental to preventing and responding to health emergencies.
- What is a WHO-Listed Authority (WLA)? A WLA is a national regulatory authority that meets the WHO’s highest international standards for regulating medical products.
- Why are WLAs significant? WLAs ensure access to safe, effective, and quality-assured medical products, particularly in low- and middle-income countries.
- How does the WLA framework differ from the previous SRA model? The WLA framework is more transparent and evidence-based, providing a clear pathway for global recognition.
- What is the ‘principle of reliance’ in the context of WLAs? It means that regulatory authorities can leverage the trusted work and decisions of designated wlas to expedite access to quality medicines.
- What is the role of the Technical Advisory Group on WLAs (TAG-WLA)? The TAG-WLA reviews the evaluations of regulatory authorities seeking WLA designation.
This is a developing story. Check back for updates.
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