过渡性工作许可证清单

The ultimate responsibility and decision for use of tWLA and WLA lists resides with the users (e.g.,regulatory authorities, procurement agencies) and will depend on the specific context of its intendeduse. In no event shall the World Health Organization be liable for any damages arising from its use. 1The time-limited WHO interim list of National Regulatory Authorities was established in September 2019 as part of theplanned transformation from the term Stringent Regulatory Authorities (SRAs) to WHO-Listed Authorities (WLA). 2Precise scope of designation for tWLAs (new medicines, multisource, biotherapeutics, biosimilar products) will befurther defined in agreement with each Regulatory Authority as part of the roadmap to listing. 3National Regulatory Authorities (NRAs) operating at maturity level 3 (ML3) and maturity level 4 (ML4), as benchmarkedagainst the WHO Global Benchmarking Tool (GBT) 4Stringent Regulatory Authorities (SRAs) as defined in theWHO Technical Report Series 1003 5NRAs exhibiting high level of performance of WHO’s six recommended regulatory functions and exercising fullregulatory oversight of any given vaccine (WHO Technical Report Series 978 Annex 6) 6Regional Reference Authorities for medicines in the Americas in the Americas (AMRO/PAHO), as assessed against WHORegional Office for the Americas (AMRO)/Pan American Health Organization (PAHO) standardized evaluation procedureand AMRO/PAHO data collection tool 7National Regulatory Authorities (NRAs) benchmarked against the WHO vaccine assessment tool and announced as"functional NRAs" before introduction of the Global Benchmarking Tool (GBT) in 2016