The World Health Organization (WHO) has officially named 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 designation is awarded to national regulatory bodies that meet globally recognized standards for overseeing the safety and quality of medical products.

With these new additions, the number of WHO-Listed Authorities has now reached 39. This growing list plays a significant role in improving access to reliable and high-quality medical products worldwide, especially in low- and middle-income countries (LMICs), where such access is often more limited.

The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea, which had already undergone WLA evaluation for both medicines and vaccines in October 2023, has now had its authority expanded to include all major regulatory responsibilities. This extension reflects Korea’s ongoing efforts in strengthening regulatory systems.

“This milestone highlights the strong dedication of these agencies to maintaining high regulatory standards,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “Their inclusion as WHO-Listed Authorities not only demonstrates the strength of their systems but also represents a valuable asset to global health. Effective and dependable regulation ensures access to safe and high-quality medical products everywhere.”

At present, roughly 70% of countries around the world still struggle with insufficient regulatory capacity for assessing and approving medical products. The WLA system encourages collaboration, consistency, and mutual recognition among regulatory agencies. This is particularly beneficial for LMICs, as they can base decisions on the trusted work of well-established authorities. The approach not only conserves valuable resources but also accelerates access to essential medications and treatments.

“Reliance is at the heart of WHO’s strategy for improving regulatory systems,” said Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. “WHO-Listed Authorities play a crucial role in fostering confidence, openness, and timely access to quality medical products, especially in countries that need them the most.”

Given that public health threats and unsafe medical products can cross borders, WLAs are vital in ensuring broader, faster, and more equitable distribution of life-saving treatments, helping protect populations worldwide.

These designations were granted following comprehensive evaluations led by WHO using established assessment tools. The findings went through careful review by the Technical Advisory Group on WHO-Listed Authorities (TAG-WLA), which convened in June 2025.

Previously, regulatory agencies in Canada, Japan, and the UK were recognized under the former system known as Stringent Regulatory Authorities (SRAs). Being reclassified under the updated WLA system marks a significant development beyond the older model, while continuing to support stable and reliable global procurement of high-quality health products.

Introduced in 2022, the WLA framework replaced the earlier SRA approach with a more transparent and evidence-driven model. It aims to enhance coordination among countries by boosting trust and alignment in regulatory practices. Through the WLA initiative, WHO continues its long-standing commitment to speeding up the availability of safe, effective, and rigorously assessed medical products across the globe.