Enhancing Global Access to Quality-Assured Medical Products with New WHO-Listed Authorities

WHO Designates Canada, Japan, and UK as ‘WHO-Listed Authorities‘ for medical Products

Geneva, Switzerland – The World Health Organization (WHO) has announced the official designation of Health canada, Japan’s Ministry of Health, Labor and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), and the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom as WHO-Listed Authorities (WLAs). This recognition signifies that these national authorities meet the highest international regulatory standards for medical products.

Wiht these additions, the WHO’s growing network of wlas now encompasses 39 agencies worldwide, aiming to accelerate access to quality-assured medical products, especially in low- and middle-income countries (LMICs).

The Republic of Korea’s Ministry of Food and Drug safety (MFDS) also saw its WLA listing expanded to cover all regulatory functions,having initially completed the assessment for both medicines and vaccines in October 2023.

“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.”

Currently, approximately 70% of countries globally grapple with weak or inadequate regulatory systems for evaluating and authorizing medical products. The WLA framework fosters regulatory convergence, harmonization, and international collaboration, enabling the WHO Prequalification Program and regulatory authorities – especially in LMICs – to leverage the trusted work and decisions of designated agencies. this collaborative approach optimizes resource utilization and improves access to life-saving medical products for millions.”The principle of reliance is central to WHO’s approach to regulatory systems strengthening and a cornerstone for effective, efficient and smart regulatory oversight of medical products,” explained Dr. Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. “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 global health threats, including substandard and falsified medical products, WLAs are vital for preparedness and equity, ensuring broader, faster, and more efficient access to life-saving products.

The designations followed a rigorous evaluation process conducted by the WHO using established benchmarking and assessment tools, reviewed by the Technical Advisory Group on WLAs (TAG-WLA) in June 2025.

Previously recognized as Stringent Regulatory Authorities (SRAs), Canada, Japan, and the UK’s designation under the WLA framework represents a meaningful evolution, maintaining continuity and stability in global procurement processes for quality-assured medical products.

Launched in 2022 as a replacement for the SRA model, the WLA initiative offers a transparent, evidence-based pathway for global recognition of regulatory authorities, facilitating regulatory convergence and reliance, and building on decades of WHO leadership.

What specific areas are assessed by the WHO when evaluating a National Regulatory Authority (NRA) for listing?

The Expanding Network of WHO-Listed Authorities

The World Health Association (WHO) plays a critical role in ensuring the quality, safety, and efficacy of medical products globally. A cornerstone of this effort is the WHO Prequalification Program, which assesses and lists manufacturers and products. Increasingly, the WHO is expanding its network by listing authorities – national regulatory authorities (NRAs) – that have demonstrated robust regulatory oversight capabilities. This shift is a game-changer for global health security and access to medicines.

what Does it Mean for an NRA to be WHO-Listed?

Being “WHO-listed” signifies that an NRA meets a defined set of standards established by the WHO. These standards cover areas like:

Regulatory Framework: A comprehensive legal and regulatory system governing medical product quality.

Inspection Capabilities: The ability to effectively inspect manufacturing facilities and ensure compliance with Good Manufacturing practices (GMP).

Laboratory Testing: Access to and utilization of qualified laboratories for product testing.

Vigilance Systems: Robust pharmacovigilance and medical device vigilance systems for monitoring product safety post-market.

Batch Release: Effective batch release procedures to guarantee product quality before distribution.

Transparency & Governance: Clear organizational structure, ethical conduct, and transparent decision-making processes.

this listing doesn’t equate to full WHO prequalification of all products regulated by that authority, but it provides a strong indication of a reliable regulatory system. It’s a crucial step towards building trust in medical product quality assurance.

Benefits of a Wider Network of Listed Authorities

The expansion of WHO-listed authorities delivers significant benefits across the healthcare landscape:

Increased Access to Essential Medicines: Listing allows products approved by these authorities to be considered for procurement by UN agencies and other international organizations,streamlining access,especially in low- and middle-income countries (LMICs).

Reduced reliance on WHO Prequalification: While WHO prequalification remains vital, relying solely on it can create bottlenecks. Listing NRAs diversifies the pathways for accessing quality-assured products.

Strengthened National Regulatory Systems: The process of seeking WHO listing incentivizes NRAs to strengthen their regulatory capacity, leading to improved public health outcomes within their own countries. This fosters regulatory strengthening.

Enhanced Supply Chain Security: A network of reliable NRAs contributes to a more secure and transparent global supply chain for medical products, mitigating the risk of substandard and falsified medicines. This is critical for combating counterfeit drugs.

Faster Product Availability: Products approved by listed authorities can reach patients more quickly,especially during public health emergencies.

The Role of Reliance and Worksharing

A key concept linked to WHO-listed authorities is “reliance.” Reliance refers to the acceptance by one regulatory authority of the decisions made by another.

Worksharing: This involves NRAs collaborating and sharing data, such as inspection reports and assessment data, to avoid duplication of effort and accelerate product review.

Positive Reliance: Accepting another authority’s approval decision as a basis for your own.

Conditional Reliance: accepting another authority’s decision with specific conditions or further verification.

WHO listing facilitates reliance and worksharing, creating a more efficient and collaborative global regulatory surroundings. This is particularly crucial for vaccine regulation and the rapid assessment of new therapies.

Current landscape: Recent listings and Geographic Distribution

As of late 2024/early 2025, the WHO has listed a growing number of NRAs from various regions. Notable examples include:

Australia (Therapeutic Goods Management – TGA): One of the first authorities to achieve listing, demonstrating a mature regulatory system.

Canada (health Canada): recognized for its rigorous assessment processes.

European medicines Agency (EMA): A leading regulatory body with global influence.

Japan (Pharmaceuticals and Medical Devices Agency – PMDA): Known for its high standards of quality control.

several NRAs in LMICs: Increasingly,authorities in countries like South Africa,Brazil,and Indonesia are achieving listing,demonstrating progress in regulatory strengthening.

The WHO continues to actively assess NRAs from all regions, with a focus on expanding the network in Africa and Asia. This geographic diversification is crucial for ensuring equitable access to quality-assured medical products.

Challenges and Future Directions

Despite the progress, challenges remain:

Sustainability of Regulatory Capacity: Maintaining a high level of regulatory capacity requires ongoing investment in training, infrastructure, and resources.

Harmonization of Standards: While the WHO provides a framework, further harmonization of regulatory standards across different regions is needed.

Data Sharing and Transparency: Improving data sharing and transparency among NRAs is essential for effective reliance and worksharing