Wednesday, August 6, 2025
The World Health Organization (WHO) has officially recognized 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 designation granted to national authorities meeting high international regulatory standards for medical products. This expansion of WLA listings to 39 global agencies supports faster access to quality-assured medical products, particularly in low- and middle-income countries (LMICs). The Republic of Korea’s Ministry of Food and Drug Safety (MFDS) has expanded its listing scope, covering regulatory functions. Dr. Tedros Adhanom Ghebreyesus highlighted that these authorities' designation reflects their commitment to regulatory excellence, emphasizing their role in promoting trust, transparency, and efficient access to life-saving medical products. Around 70% of countries still face significant challenges due to weak regulatory systems, and the WLA framework promotes regulatory convergence, harmonization, and international collaboration. This collaboration allows WHO Prequalification and regulatory authorities, especially in LMICs, to rely on designated agencies’ decisions. The process involves rigorous evaluations by the TAG-WLA, which ensures transparency and evidence-based pathways. Canada, Japan, and the UK’s authorities were previously SRA authorities and now part of the WLA initiative, which launched in 2022 to replace the SRA model and ensure continuity and stability in global medical product procurement. The initiative builds on WHO’s decades of efforts to enhance global cooperation on medical product regulation, fostering trust, transparency, and efficient access to life-saving products.
Reference: WHO designates new WHO-Listed Authorities, strengthening global access to quality-assured medical productsLabels: WHO
0 Comments