WHO-Listed Authorities: Strengthening Global Medical Product Access

WHO Expands List of Top Regulatory Authorities, Paving Way for Faster Access to Life-Saving Medicines

The world Health Institution (WHO) has announced the designation ‍of Health Canada, Japan’s ‍Ministry of Health, Labor and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA), and the UK’s Medicines and Healthcare products regulatory agency (MHRA) as WHO-Listed Authorities (WLAs).This ‍recognition signifies that these national agencies meet the highest international standards for⁢ regulating medical products, a crucial step towards ensuring global access to safe and effective healthcare.

This expansion brings the total number of WLAs worldwide to 39, bolstering efforts to accelerate access to quality-assured medicines, especially in low- and middle-income countries (LMICs). The Republic of Korea’s Ministry ⁤of Food and Drug Safety ‍(MFDS) also recently expanded its WLA⁤ scope to encompass all regulatory functions, having been among the first⁣ to complete 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.”

Addressing a Critical Global Need

Currently, approximately 70% of countries globally grapple with weak or inadequate regulatory systems for evaluating and authorizing medical products. This poses meaningful risks ⁢to public health and hinders access to⁤ essential medicines. The WLA framework directly addresses this challenge by fostering regulatory convergence, harmonization, and international‍ collaboration.

This collaborative approach allows the WHO Prequalification ⁤Programme and regulatory authorities – especially those in LMICs – to leverage the trusted evaluations and decisions of designated WLAs.By streamlining processes and promoting reliance on established standards, the WLA initiative supports efficient resource allocation ⁣and accelerates ⁢access to life-saving treatments 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, openness, and faster access to quality-assured medical products, especially in low- and middle-income countries.”

Combating Substandard and Falsified Products ⁤&⁢ Building Global Preparedness

In an increasingly interconnected world, the threat of substandard and falsified medical products is a growing concern. WLAs play a vital role in mitigating this risk by establishing robust regulatory frameworks and promoting international cooperation. They are also essential pillars of global health security, ensuring a more rapid and equitable distribution of life-saving products‍ during health emergencies.

A New Era of regulatory Recognition

The WLA designations follow a rigorous evaluation process conducted by the WHO, utilizing globally recognized benchmarking and assessment tools.These evaluations were ⁤thoroughly reviewed by⁤ the ‍Technical Advisory Group on WLAs (TAG-WLA)⁤ in June⁤ 2025.

Importantly, Canada, ⁣Japan, and the UK’s regulatory authorities were previously recognized as Stringent Regulatory Authorities (SRAs). The transition to the WLA framework represents a significant evolution,offering a more transparent and evidence-based pathway for global recognition while maintaining continuity and stability in global procurement processes.

Launched in 2022, the WLA initiative replaces the former SRA model, building on decades of WHO leadership ⁣in promoting international regulatory collaboration. The ultimate goal is to expedite access ⁤to safe, effective, and quality-assured medical products for people ⁣worldwide, strengthening global health security and equity.