The WHO listed Swissmedic as a WHO Listed Authority (WLA) on 30th October 2023. Regulatory authorities that are listed as WLAs comply with international standards and practices and have been assessed by the WHO. In this way, the World Health Organization aims to ensure that only safe, effective and high-quality medicinal products are on the market worldwide.
Swissmedic, already considered as stringent regulatory authority, is now listed as a WHO Listed Authority (WLA) and recognised in all regulatory functions. After the assessment carried out by the WHO based on its global Benchmarking Tool (GBT), the Technical Advisory Group recommended inclusion of Swissmedic.
Swissmedic Executive Director Raimund Bruhin is proud of this achievement: “I am very pleased that the World Health Organization (WHO) recognises Swissmedic as a competent authority in all areas of expertise, documented by its inclusion in the list of WHO Listed Authorities. WHO decided this based on an internationally developed, demanding benchmarking tool. This further qualifies Swissmedic in its commitment to contribute to the strengthening of the regulatory system of LMICs (low and middle income countries) under the umbrella of the WHO.”
The WLA framework was initiated based on World Health Assembly Resolution 67.20 “Regulatory system strengthening for medical products” and the WHO Roadmap for access to medicines, vaccines and health products 2019-2023.
A WHO Listed Authority (WLA) is a regulatory authority which has been documented to comply with all the relevant indicators and requirements. These are specified by WHO for the requested scope of listing based on an established benchmarking and performance evaluation process. According to WHO, the WLA-framework – including the listing of WLAs – provides a transparent and evidence-based pathway for regulatory authorities to be globally recognised as meeting WHO and other internationally recognised standards and practices. Having a list of trusted WLAs in place will facilitate reliance amongst regulatory authorities and enhance international cooperation with the aim of promoting access to safe, effective, high-quality medicinal products.
The List of WHO listed authorities is published on the WHO website.
WHA Resolution 67.20 - Regulatory system strengthening for medical products (2014) https://apps.who.int/gb/ebwha/pdf_files/WHA67/A67_R20-en.pdf
Roadmap for access to medicines, vaccines and health product 2019-2023: comprehensive support for access to medicines, vaccines and other health products https://apps.who.int/iris/handle/10665/330145