From benchmarking to global leadership: Singapore's health sciences authority's journey to WHO maturity level 4 and WHO-Listed Authority status for medicines.
СтатьяНазвание и аннотация: Перевод в очереди
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Toh Dorothy, Lim Adena, Chan Agnes, Chia Alvin, Ang Pei San, Tan Annie, Foo Belinda, Chan Betty, Chong Limei, Choo Qiuyi, Choong Chih Tzer, Ho Christine, Chua Siew Wei, Chuah Shin Chet, Rodrigues Clare Louise, Chuah Damian, Sun Debbie, Koh Diana, Yeo Doris, Tan Esther, Goh Eugene, Lee Evelyn, Ee Flavian, Foo Freddie, Ge Xiao Wei, Goh Cheong Hian, Han Phey Yen, Poh Jalene, Low Jean, Teo Jessica, Ng Joyce, Lai Weng Fai, Lee Hui Keng, Lim Boon Kian, Lim Li Lian, Lim Na, Lin Sharon, Ling Boon Lee, Tan Lisa, Looi Yee Hoo, Low Min Yong, Limenta Michael, Ng Liong Thiam, Ong Shu Yi, Peck Li Fung, Soh Sally, Seng Tzer Jing, Shinta, Sachidanandan Sumitra, Soh Xiu Wei, Tan Sue Kim, Tang Xuhua, Tham Mun Yee, Toh Tiong, Gan Valerie, Lai Valerie, Xu Yimin, Yang Silin, Yeo Weilong, Yip Yean Yean, Chan Cheng Leng
Аннотация
This article aims to describe Singapore Health Sciences Authority's (HSA's) multi-year journey to attaining World Health Organisation (WHO) Maturity Level 4 (ML4) and WHO-Listed Authority (WLA) status for medicines regulatory functions, presenting HSA as a descriptive policy case study on the practical application of the WHO Global Benchmarking Tool (GBT) and WLA frameworks. It outlines the benchmarking and Performance Evaluation (PE) processes, including the scope of assessment, phased reviews, and key milestones achieved between 2021 and 2024. HSA became the first regulator globally to achieve ML4 for medicines, before progressing through the WLA Performance Evaluation and eventually securing WLA listing across all medicines' regulatory functions. The article examines the institutional factors that enabled these achievements, including strong governance, sustained leadership commitment, technical expertise, digitalised regulatory workflows, and close engagement with international partners. The findings highlight that ML4 and WLA recognition are not merely markers of national regulatory excellence, but strategic enablers that strengthen regulatory credibility, support international reliance by other authorities, and contribute to more timely access to safe, effective, and quality-assured health products. HSA's experience also underscores that attaining and sustaining advanced regulatory maturity requires long-term investment in systems, people, oversight, and innovation, particularly as regulatory agencies take on broader roles in supporting regional and global public health.