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The World Health Organization (WHO) has approved the designation of 33 national and regional regulatory authorities as WHO Listed Authorities (WLAs), reaching a total of 36 authorities from 34 Member States since the initiative's launch in March 2022. WLAs are regulatory bodies that can be relied on to meet the most stringent standards and practices for ensuring the quality, safety, and effectiveness of medicines and vaccines.
Among the newly approved WLAs are important regulatory authorities such as the U.S. Food and Drug Administration (US FDA) and the European Medicines Regulatory Network (EMRN), comprising the regulatory agencies of 30 European countries. Additionally, the Health Sciences Authority (HSA) of Singapore, initially designated as a WLA in October 2023, has now been approved for an expanded scope of functions.
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, highlighted this development as a significant step towards improving access to safe and effective medicines and vaccines globally. The decision to designate these authorities as WLAs was based on recommendations by the WHO technical advisory group and rigorous performance evaluations, confirming their adherence to international standards and best regulatory practices. The approval encompasses various regulatory functions, underscoring the commitment of these agencies to ensuring the quality, safety, and efficacy of medical products.
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