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Regulatory Agencies Expand Under WHO Framework, Boosting Global Medicine Standards

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Regulatory agencies for medical products have significantly increased in number under the expansion of the World Health Organization (WHO) Listed Authorities (WLA) framework. This development marks a milestone in the global regulation of medicines and vaccines, ensuring higher standards of safety, quality, and efficacy. A total of 33 regulatory agencies have now been designated as Listed Authorities under the WLA framework. These regulatory agencies have been validated and recognized for their commitment to maintaining the highest regulatory standards and practices.

The newly approved WLAs include major regulatory bodies such as the European Medicines Regulatory Network (EMRN)—comprising the European Commission (EC), the European Medicines Agency (EMA), and the medicines regulatory agencies of 30 European countries—as well as the US Food and Drug Administration (FDA). With these additions, the WLA listing now encompasses 36 regulatory agencies from 34 member states.

Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, highlighted the importance of this expansion, stating that it represents significant progress in improving access to safe, effective, and quality medicines and vaccines. He emphasized that the approval of these agencies under the WLA framework would enhance global health by ensuring that medicines and vaccines meet rigorous regulatory standards.

Regulatory Agencies Gain WHO-Listed Status, Enhancing Global Health Security and Efficiency

The WHO Listed Authorities framework serves as a testament to the consistency and advanced performance of these regulatory agencies in meeting international standards and best practices. The WHO technical advisory group on WHO Listed Authorities (TAG-WLA) confirmed that these regulatory agencies have demonstrated their ability to uphold the highest levels of regulatory standards consistently. This recognition is crucial as it allows these agencies to streamline regulatory processes, optimize resources, and expedite the availability of essential medicines and vaccines.

Dr. Yukiko Nakatani, Assistant Director-General for Access to Medicines and Health Products, and Antimicrobial Resistance ad interim, explained the significance of the WLA status. She noted that as WHO Listed Authorities, these agencies can assure the quality and safety of medicines and vaccines, thereby enhancing global health security. The streamlined processes enabled by the WLA designation allow for more efficient use of resources and faster access to vital medical products.

Janis Bernat, Director of Scientific and Regulatory Affairs at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), praised the listed regulatory agencies and the WHO for their leadership in this area. Bernat emphasized that regulatory reliance fosters efficiency and collaboration among regulatory authorities worldwide. By leveraging each other’s evaluations while maintaining accountability for patient safety, these agencies can enhance the overall regulatory landscape.

Regulatory Agencies

Regulatory Agencies Recognized Under WHO WLA Framework: A Commitment to Global Health Standards

The recognition of these regulatory agencies as Listed Authorities under the WLA framework signifies a robust commitment to global health. It ensures that the highest standards are upheld in the regulation of medical products, benefiting patients and healthcare systems worldwide. This framework promotes collaboration and mutual reliance among regulatory agencies, which is essential for addressing the complex challenges of modern healthcare.

The European Medicines Regulatory Network (EMRN), as one of the key entities recognized under the WLA framework, plays a pivotal role in this collaborative effort. The EMRN’s inclusion highlights the high standards maintained by European regulatory agencies and their commitment to safeguarding public health. The US FDA’s inclusion further underscores the importance of international cooperation in regulatory practices. As a globally recognized regulatory authority, the FDA’s participation in the WLA framework enhances the credibility and reliability of the entire system.

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In conclusion, the expansion of the WHO Listed Authorities framework and the recognition of leading regulatory agencies marks a significant advancement in global health governance. This initiative ensures that patients worldwide have access to safe, effective, and high-quality medical products. The commitment of these agencies to uphold the highest regulatory standards will continue to drive improvements in healthcare outcomes and strengthen the global regulatory environment.


Resource: World Health Organization, May 20, 2024

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