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

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The World Health Organization (WHO) has officially designated Health Canada, the Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA) of Japan, and the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom as WHO-Listed Authorities (WLAs), a status granted to national authorities that meet the highest international regulatory standards for medical products.

With these latest designations, WHO expands the growing list of WLAs, now involving 39 agencies across the world, supporting faster and broader access to quality-assured medical products, particularly in low- and middle-income countries (LMICs).

In addition, the Republic of Korea’s Ministry of Food and Drug Safety (MFDS) – one of the first regulatory authorities to complete the WLA assessment for both medicines and vaccines in October 2023 – has had its listing scope successfully expanded, now covering all regulatory functions.

Around 70% of countries worldwide still face significant challenges due to weak or inadequate regulatory systems for evaluating and authorizing medical products. The WLA framework promotes regulatory convergence, harmonization and international collaboration, allowing WHO Prequalification Programme and regulatory authorities, especially those in LMICs, to rely on the trusted work and decisions of designated agencies. This collaboration supports efficient use of limited resources, enabling better and faster access to quality-assured life-saving medical products to millions more people.

In a world where health threats, including substandard and falsified medical products, know no borders, WLAs also serve as critical pillars of preparedness and equity, making life-saving products available more broadly, rapidly and efficiently.

The designations follow a rigorous performance evaluation process carried out by WHO using its globally recognized benchmarking and assessment tools. These evaluations were reviewed by the Technical Advisory Group on WLAs (TAG-WLA), which convened in June 2025.

Canada, Japan and the UK’s regulatory authorities were previously recognized as Stringent Regulatory Authorities (SRAs). Their designation under the WLA framework marks an important step in moving beyond the old SRA system, while ensuring continuity and stability in global procurement processes of quality-assured medical products.

Launched in 2022 to replace the previous SRA model, the WLA initiative provides a transparent and evidence-based pathway for global recognition of regulatory authorities to facilitate regulatory convergence and reliance. It builds on decades of WHO leadership to help countries work together more closely on regulating medical products, speeding up access to safe, effective and quality-assured medical products for people around the world. 

Central Drugs Standard Control Organisation (CDSCO) of India is the WHO-Listed Authorities (WLAs) with the following details:

  1. Maturity Level (ML): ML3
  2. Scope of products: Vaccines ( producing )
  3. Year of announcement: 2017 & 2024

Reference:

  1. WHO News,  
  2. A Framework for evaluating and publicly designating regulatory authorities as WHO Listed Authorities (WLA)
  3. List of WLAs

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