Landmark listing of first three countries as WHO-Listed regulatory Authorities

The Health Sciences Authority (HSA), Singapore; the Ministry of Food and Drug Safety (MFDS), Republic of Korea; and the Swiss Agency for Therapeutic Products (Swissmedic), Switzerland are the first three countries to be listed as WHO-Listed Authorities.

A WHO-Listed Authority (WLA) is a regulatory authority or a regional regulatory system which has been documented to comply with all the indicators and requirements specified by WHO for the requested scope of listing based on an established benchmarking and perfance evaluation process.

Members of the technical advisory group on WHO-Listed Authorities (TAG-WLA) met for the first time, 11 to 12 September 2023, at WHO headquarters in Geneva, Switzerland and reached a consensus to recommend the listing of HSA, MFDS and Swissmedic as WHO-Listed Authorities, after discussing the findings of the performance evaluations of these three regulatory authorities.

This represents a significant milestone for the Republic of Korea, Singapore and Switzerland, as the designation and public listing of MFDS, HSA and Swissmedic as WLAs, is a global recognition that these three regulatory authorities meet WHO and other internationally recognized regulatory standards and practices.

“This achievement is the result of investment by the Governments of the Republic of Korea, Singapore and Switzerland in the strengthening of their regulatory systems and reaffirms the collaboration between WHO and the three Governments in promoting confidence, trust and further reliance on authorities that have attained this global recognition, through the transparent and evidence-based pathway for designating and listing of WLAs”, said Dr Yukiko Nakatani Assistant Director-General for Access to Medicines and Health Products.

The introduction of a framework for designating and publicly listing a regulatory authority as a WHO Listed Authority (WLA) responds to Member States’ requests to develop a transparent and evidence-based pathway for regulatory authorities operating at an advanced level of performance to be globally recognized, 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.

While the ultimate responsibility and decision for use of the WLA list resides with the users and depends on the specific context of its intended use, the benefits of a robust, transparent, evidence-based, global system for recognizing regulatory excellence serve the interests of a variety of stakeholders that are committed to promoting access to safe, effective, and quality medical products. It is expected that HSA, MFDS and Swissmedic will sustain this achievement, thereby enabling greater regulatory efficiencies and more informed decision-making at the national, regional and global levels.

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