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 thespecific context of its intendeduse. In no event shall the World Health Organization be liable for any damages arising from its use. 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 benchmarkedagainsttheWHO Global Benchmarking Tool (GBT)4Stringent Regulatory Authorities (SRAs) as defined in theWHO Technical Report Series 10035NRAs exhibitinghigh level of performance of WHO’s six recommended regulatory functions andexercisingfullregulatory 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), asassessedagainst WHORegional Office for the Americas (AMRO)/Pan American Health Organization (PAHO) standardized evaluation procedureand AMRO/PAHO data collection tool7National Regulatory Authorities (NRAs)benchmarkedagainst the WHO vaccine assessment tool and announced as"functional NRAs" before introduction of the Global Benchmarking Tool (GBT) in 2016