WHO Lists 33 Regulatory Authorities for Straightening Medicine and Vaccine Standards

Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, emphasized the significance of this progress in improving access to safe, quality, and effective medicines and vaccines worldwide.

The World Health Organization (WHO) has approved the designation of 33 national and regional regulatory authorities as WHO Listed Authorities (WLAs), bringing the total to 36 regulatory authorities from 34 Member States since the initiative's launch in March 2022. This designation signifies that these authorities fulfill the highest level of regulatory standards and practices for the quality, safety, and efficacy of medicines and vaccines.

The newly approved WLAs include prominent agencies such as the U.S. Food and Drug Administration (US FDA) and the European Medicines Regulatory Network (EMRN), which comprises regulatory bodies from 30 European countries. Additionally, the Health Sciences Authority (HSA) of Singapore, previously designated as a WLA in October 2023, was approved for an expanded scope of functions.

Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, emphasized the significance of this progress in improving access to safe, quality, and effective medicines and vaccines worldwide. He commended the designated agencies for their investment and commitment to upholding the highest standards of quality and safety.

The decision to approve these WLAs was based on recommendations from the WHO technical advisory group on WHO Listed Authorities (TAG-WLA), which conducted performance evaluations to ensure consistency with international standards and best regulatory practices.

Dr. Yukiko Nakatani, Assistant Director-General for Access to Medicines and Health Products, described this expansion of the WLA framework as a transformative milestone in the global public health regulatory landscape. WLAs can be relied upon to ensure the quality and safety of medicines and vaccines, streamline processes, optimize resources, and expedite access to essential healthcare products.

The approval for agencies like the US FDA, EMRN, and HSA covers all regulatory functions for medicines, including generics, new chemical entities, biotherapeutics, and vaccines. Attaining WLA status reflects not only compliance with stringent standards but also a commitment to continuous improvement and excellence in regulatory oversight. Some regulatory authorities are still pending evaluation following their expressions of interest in achieving WLA designation.