The World Health Organization (WHO) announced on May 20 that it has named the U.S. Food and Drug Administration as a WHO-Listed Authority (WLA) that can be relied on for fulfilling the highest level of regulatory standards and practices for quality, safety, and efficacy of medicines and vaccines as determined by the WHO. The old designation of “stringent regulatory authority” was replaced by the WHO in March 2022 after moving to the WLA approach, which provides a transparent, evidence-based pathway for regulatory authorities seeking to demonstrate that they operate at an advanced, globally recognized level of performance. The FDA’s participation and collaboration in the new designation system supports this paradigm and its capacity to further international regulatory harmonization and reliance by providing a means to measure regulatory programs against common metrics.
Source: Food and Drug Administration
“The FDA is delighted to be named a WHO-Listed Authority,” said FDA Deputy Commissioner for Policy, Legislation, and International Affairs Kim Trzeciak. “We have fully supported the WHO’s decision to transition to a new designation that lists those regulatory authorities operating at an advanced level of performance. The FDA began the evaluation process with the WHO last year to obtain the WLA designation, and we encourage other regulatory authorities of appropriate maturity level to do the same.”
The decision to approve the 2024 designations was based on the recommendation by the WHO technical advisory group on WHO-Listed Authorities following WHO performance evaluations confirming consistency of advanced performance by these authorities in line with international standards and best regulatory practices for ensuring the quality, safety, and efficacy of medicines and vaccines. Attaining WLA status signifies not only compliance with these standards but also a commitment to continuous improvement and excellence in regulatory oversight – a commitment consistently demonstrated by the FDA and other WLAs.
In addition to the FDA, the other newly approved WLAs include the European Medicines Regulatory Network (EMRN), which comprises the European Commission, the European Medicines Agency, and the regulatory authorities of the following 30 countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. The WHO approval for both the FDA and EMRN includes all regulatory functions for the product streams of medicines – including multisource (generics) and new medicines (new chemical entities), biotherapeutics, and similar biotherapeutic products – and vaccines.
The updated list of countries or regulatory systems that are recognized makes a total of 36 regulatory authorities from 34 Member States now designated as WLAs. Three countries received the WLA designation in 2023 after completing the WHO’s evaluation and benchmarking process: the Republic of Korea, Singapore, and Switzerland.
“Today marks a significant progress in our collective efforts to improve access to safe, quality, and effective medicines and vaccines. With leading regulatory authorities joining our list, we are stronger and more united to improve access to quality, safe and effective medicines and vaccines for millions more people,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General. “I would like to congratulate all agencies designated as WLAs for their investment and commitment to the quality and safety of medicines and vaccines. My thanks also to our experts for their diligent work to implement a transparent and evidence-based assessment throughout the evaluation process.”
