WHO recognizes new WHO-Listed Authorities, strengthening global access to quality-assured medical products

WHO recognizes additional WHO-Listed Authorities to advance global access to high-quality medical products

On August 7, 2025, the World Health Organization (WHO) added three national authorities to the list of WHO-Listed Authorities (WLA) — including Health Canada (Canada), the Ministry of Health, Labour and Welfare / Pharmaceuticals and Medical Devices Agency (MHLW/PMDA, Japan), and the Medicines and Healthcare products Regulatory Agency (MHRA, United Kingdom).

Expanding the WLA list – Impact on global health access

With this addition, the total number of WLAs worldwide has reached 39 authorities, helping accelerate broader distribution of quality-assured medical products — especially in low- and middle-income countries.

Notably, South Korea (MFDS) — one of the first authorities to complete the WLA assessment for both medicines and vaccines in October 2023 — has expanded the scope of its assessment to include all relevant regulatory functions.

Regulatory consistency and resource efficiency

WHO Director-General Dr. Tedros Adhanom Ghebreyesus noted that this recognition demonstrates the authorities’ strong commitment to maintaining rigorous quality regulatory systems. These authorities not only represent regulatory credibility, but are also valuable assets for global health, helping ensure that everyone can access safe, effective, and high-quality medical products.

Today, around 70% of countries still face difficulties in assessing and authorizing medical products due to weak regulatory systems. In this context, the WLA framework promotes regulatory convergence, standards harmonization, and stronger international cooperation. As a result, WHO prequalification programs and regulators in low-income countries can rely on outcomes from WLA authorities to inform decisions — enabling more efficient allocation of resources and expanding access to life-saving medical products for millions of people.

The “reliance” principle and WLA’s contribution to the global health system

Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data, emphasized that the reliance principle is central to the strategy for strengthening regulatory capacity. WLAs serve as a foundational pillar, fostering trust, transparency, and faster access to quality medical products, particularly in low- and middle-income countries.

In a borderless world where falsified or substandard medical products pose public health risks, WLA authorities become a critical anchor for emergency preparedness and strengthening health equity — ensuring life-saving products reach those in need more widely, quickly, and effectively.

The WLA framework – A transparent, evidence-based step forward

The “WHO-Listed Authorities” framework was launched in 2022 to replace the previous “Stringent Regulatory Authority (SRA)” model. WLA establishes a transparent, evidence-based recognition foundation, enabling globally recognized acknowledgment of high-performing regulators and reinforcing international regulatory convergence.

Future outlook

The addition of Health Canada, MHLW/PMDA (Japan), and MHRA (UK) to the WLA list marks an important step toward building a global health system that is trustworthy, collaborative, and effective. This creates opportunities for faster and fairer access to essential medical products for all countries, especially those with limited regulatory capacity.

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