From benchmarking to global leadership: Singapore’s health sciences authority’s journey to WHO maturity level 4 and WHO-Listed Authority status for medicines
Year: 2026
Type: article
Abstract: 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.
Source: Frontiers in Medicine
Authors: Dorothy Toh, Adena Lim, Agnes Chan, Alvin Chia, Pei San Ang, Annie Tan, Belinda Foo, Betty Chan, Limei Chong, Qiuyi Choo, Chih Tzer Choong, Christine Ho, Siew Wei Chua, Shin Chet Chuah, Clare Louise Rodrigues, Damian Chuah, Debbie Sun, Diana Koh, Doris Yeo, Esther Tan, Eugene Goh, Evelyn Lee, Flavian Ee, Freddie Foo, Xiao Wei Ge, Cheong Hian Goh, Phey Yen Han, Jalene Poh, Jean Low, Jessica Teo, Joyce Ng, Weng Fai Lai, Hui Keng Lee, Boon Kian Lim, Li Lian Lim, Na Lim, Sharon Lin, Boon Lee Ling, Lisa Tan, Yee Hoo Looi, Min Yong Low, Michael Limenta, Liong Thiam Ng, Shu Yi Ong, Li Fung Peck, Sally Soh, Tzer Jing Seng, Shinta, Sumitra Sachidanandan, Xiu Wei Soh, Sue Kim Tan, Xuhua Tang, Mun Yee Tham, Tiong Toh, Valerie Gan, Valerie Lai, Yimin Xu, Silin Yang, Weilong Yeo, Yean Yean Yip, Cheng Leng Chan
Institution: Health Sciences Authority
Language: English
Topic: Healthcare Regulation
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,801
OpenAlex ID: W7207614742