Who Expands Global Network Of Trusted Medical Product Regulators

The World Health Organization (WHO) has officially designated Health Canada, nan Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices Agency (MHLW/PMDA) of Japan, and nan Medicines and Healthcare products Regulatory Agency (MHRA) of nan United Kingdom arsenic WHO-Listed Authorities (WLAs), a position granted to nationalist authorities that meet nan highest world regulatory standards for aesculapian products.

With these latest designations, WHO expands nan increasing database of WLAs, now involving 39 agencies crossed nan world, supporting faster and broader entree to quality-assured aesculapian products, peculiarly successful low- and middle-income countries (LMICs).

In addition, nan Republic of Korea's Ministry of Food and Drug Safety (MFDS) – 1 of nan first regulatory authorities to complete nan WLA appraisal for some medicines and vaccines successful October 2023 – has had its listing scope successfully expanded, now covering each regulatory functions.

This nickname reflects nan heavy committedness of these authorities to regulatory excellence. Their nickname arsenic WHO-Listed Authorities is not only a testament to their robust regulatory systems but besides a captious publication to world nationalist health. Strong and trusted regulators thief guarantee that group everyplace person entree to safe, effective, and high-quality aesculapian products."

Dr. Tedros Adhanom Ghebreyesus, WHO Director-General

Around 70% of countries worldwide still look important challenges owed to anemic aliases inadequate regulatory systems for evaluating and authorizing aesculapian products. The WLA model promotes regulatory convergence, harmonization and world collaboration, allowing WHO Prequalification Programme and regulatory authorities, particularly those successful LMICs, to trust connected nan trusted activity and decisions of designated agencies. This collaboration supports businesslike usage of constricted resources, enabling amended and faster entree to quality-assured life-saving aesculapian products to millions much people.

"The rule of reliance is cardinal to WHO's attack to regulatory systems strengthening and a cornerstone for effective, businesslike and smart regulatory oversight of aesculapian products," said Dr Yukiko Nakatani, WHO Assistant Director-General for Health Systems, Access and Data. "WHO-Listed Authorities are cardinal enablers successful promoting trust, transparency, and faster entree to quality-assured aesculapian products, particularly successful low- and middle-income countries."

In a world wherever wellness threats, including substandard and falsified aesculapian products, cognize nary borders, WLAs besides service arsenic captious pillars of preparedness and equity, making life-saving products disposable much broadly, quickly and efficiently.

The designations travel a rigorous capacity information process carried retired by WHO utilizing its globally recognized benchmarking and appraisal tools. These evaluations were reviewed by nan Technical Advisory Group connected WLAs (TAG-WLA), which convened successful June 2025.

Canada, Japan and nan UK's regulatory authorities were antecedently recognized arsenic Stringent Regulatory Authorities (SRAs). Their nickname nether nan WLA model marks an important measurement successful moving beyond nan aged SRA system, while ensuring continuity and stableness successful world procurement processes of quality-assured aesculapian products.

Launched successful 2022 to switch nan erstwhile SRA model, nan WLA inaugural provides a transparent and evidence-based pathway for world nickname of regulatory authorities to facilitate regulatory convergence and reliance. It builds connected decades of WHO activity to thief countries activity together much intimately connected regulating aesculapian products, speeding up entree to safe, effective and quality-assured aesculapian products for group astir nan world.