The World Health Organization (WHO) has designated Health Canada, the Ministry of Health, Labor and Welfare and Agency for Pharmaceutical and Medical Devices of Japan, and the Regulatory Agency of the United Kingdom and Health Products such as WHO-Genotated authorities that meet the national authority granted to the National Authority granted to the National Authority Given the Status Die Satus Die Get the National Authority). To the national authorities for medical rules.
This means that 39 agencies worldwide are referred to as WLAs, which support faster and broader access to high -quality medical products, especially in countries with low and middle income (LMICs).
In addition, the Ministry of Food and Drugs of the Republic of Korea – one of the first regulatory authorities that completed the WLA assessment for both medicines and vaccines in October 2023 – has expanded its indication range to cover all regulatory functions.
About 70 percent of countries are still confronted with significant health care challenges due to weak or insufficient regulatory systems for evaluating and authorizing medical products. The WLA framework promotes regulatory convergence, harmonization and international cooperation, so that the WHO -PRE qualification program and the regulatory authorities, in particular those in LMICs, can rely on the trusted work and decisions of designated agencies.
In a world where health threats, including substandard and forged medical products, have no limits, WLA’s critical pillars that make life -saving products more wider, fast and efficiently available.
The instructions follow on a rigorous performance evaluation that was carried out by WHO with the help of his worldwide -recognized benchmarking and assessment instruments. The evaluations were assessed by the Technical Advisory Group on WLAS, which met in June 2025.
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Published on August 11, 2025
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