The World Health Organization (WHO) has approved the designation of 33 national and regional regulatory authorities as WHO Listed Authorities (WLAs), marking a significant step in ensuring the highest standards of regulatory oversight for medicines and vaccines. This brings the total number of WLAs to 36 from 34 Member States since the initiative’s launch in March 2022.
Among the newly approved WLAs are prestigious bodies such as the U.S. Food and Drug Administration (US FDA) and the European Medicines Regulatory Network (EMRN), comprising regulatory agencies from 30 European countries. Additionally, Singapore’s Health Sciences Authority (HSA), previously designated as a WLA in October 2023, has expanded its scope to include market surveillance and control functions.
Dr Tedros Adhanom Ghebreyesus, WHO Director-General, emphasized the significance of this expansion, highlighting its role in improving access to safe, quality, and effective medicines and vaccines worldwide. The decision to designate these authorities as WLAs follows rigorous assessments by WHO’s technical advisory group, confirming their adherence to international standards and best regulatory practices.
Dr Yukiko Nakatani, Assistant Director-General at WHO, described the expansion as a transformative milestone in global public health regulation, enabling WLAs to streamline processes and expedite access to essential medicines and vaccines. The approvals underscore these agencies’ commitment to continuous improvement and excellence in regulatory oversight.
Several stringent regulatory authorities are currently undergoing evaluations following their expressions of interest in achieving WLA designation.
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