Singapore’s Health Sciences Authority (HSA), South Korea’s Ministry of Food and Drug Safety (MFDS) and the Swiss Agency for Therapeutic Products (Swissmedic) are the first three countries to receive the status of WHO-Listed Authorities (WLA) in a landmark step.
A WLA is a regulatory authority, or a regional regulatory system, that complies with the WHO requirements, based on their established benchmarking and performance evaluation processes.
Members of the technical advisory group on WLAs (TAG-WLA) met for the first time, in September 2023, at WHO headquarters in Geneva, Switzerland and reached a consensus to recommend the inclusion of HSA, MFDS and Swissmedic as WLAs.
This is a significant milestone for Korea, Singapore and Switzerland, as the designation of their national agencies as WLAs, is recognition at a global level that these three regulatory authorities meet WHO, and other internationally recognised, regulatory standards.
The introduction of a framework for designating and publicly listing a regulatory authority as a WLA responds to WHO member states’ requests to develop a transparent and evidence-based pathway for regulatory authorities operating at an advanced level of performance to be globally recognised, thereby replacing the procurement-oriented concept of stringent regulatory authorities.
Implementation of the WLA framework is intended to promote access, and supply of safe, effective and quality medical products. The framework also provides for the optimal use of limited resources by facilitating reliance on the work products and decisions of trusted agencies in the decision-making of regulatory authorities, the WHO Prequalification Programme and procurement agencies.