Future role for Gulf states?
The World Health Organization (WHO) has designated national regulatory authorities in Canada, the United Kingdom, and Japan as WHO-Listed Authorities, a classification reserved for agencies that meet the highest international standards for overseeing medical products.
The move is part of a broader effort to strengthen global access to safe and effective medicines, particularly in low- and middle-income countries.
The designation was given to Health Canada, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and Japan’s Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA).
These agencies join a growing list of 39 WHO-Listed Authorities (WLAs) recognised for their capacity to independently assess and monitor the quality, safety and efficacy of medicines, vaccines and other health technologies.
The WHO also expanded the listing scope of South Korea’s Ministry of Food and Drug Safety (MFDS), which now covers all regulatory functions. MFDS was one of the first agencies to pass the WHO’s assessment process for both medicines and vaccines.
The new listings come amid ongoing concerns about access to quality-assured medical products in lower-income regions.
According to WHO data, nearly 70% of countries worldwide still lack effective regulatory systems to evaluate and approve medicines and other health technologies. This contributes to the prevalence of substandard or falsified medical products, particularly across parts of Africa, the Middle East and Asia.
The WLA framework, introduced in 2022, replaces the older system of Stringent Regulatory Authorities (SRAs), offering a more transparent and structured method for evaluating national agencies. The system is intended to foster international collaboration and regulatory convergence, allowing authorities in lower-capacity countries to rely on decisions made by trusted WLAs.
In the Middle East and Africa, where health systems continue to face strain from conflict, climate-related crises and economic instability, WHO’s recognition of WLAs is seen as a step towards improved medical supply chains.
Arabian Gulf states, including the UAE and Saudi Arabia, which have been working to strengthen their regulatory systems, may look to align further with the WLA framework to enhance regional pharmaceutical oversight and reduce dependency on fragmented procurement routes.
A 2024 report by the Global Health Observatory showed that up to 40% of medicines sold in some parts of sub-Saharan Africa are considered substandard or counterfeit, underscoring the urgency of regulatory reform.
WHO says the WLA initiative helps ensure faster and more reliable access to high-quality treatments by allowing procurement agencies and national health systems to rely on already-reviewed products.
The evaluation process for becoming a WLA involves a comprehensive benchmarking system developed by WHO and is reviewed by a Technical Advisory Group. The inclusion of Canada, the UK and Japan is part of a broader strategic shift to enhance international trust in regulatory bodies, especially in the context of future pandemics or cross-border health threats.
Officials at WHO argue that the WLA model supports smarter use of limited resources in low- and middle-income countries by reducing duplication in the regulatory process. This means national agencies can focus on post-market surveillance, safety monitoring and context-specific health needs while relying on WLA decisions for product authorisation.
While the new designations are largely symbolic in high-income countries with already robust systems, they are expected to carry practical benefits for developing economies by accelerating the availability of essential medical products. They also signal a shift in WHO’s approach to global health governance, favouring collaboration and shared accountability.
The WLA list is expected to expand further in the coming years, with several countries in the Middle East and Africa undergoing assessments or aligning their regulatory structures with WHO benchmarks. The UAE, already a key player in regional medicine distribution, has previously expressed interest in enhancing its role in international pharmaceutical regulation.
As global demand for vaccines, diagnostics and treatments continues to grow, especially following Covid-19, the role of trusted regulatory bodies is increasingly critical. WHO’s WLA initiative aims to ensure that medical products are not only practical and safe but also accessible, regardless of geography or income level.
Image: The WLA framework, introduced in 2022, replaces the older system of Stringent Regulatory Authorities (SRAs). Credit: Mikhail Nilov
