The Health Sciences Authority (HSA) has achieved further recognition from the World Health Organization (WHO) for its medicines regulatory system, particularly in market surveillance and control. This latest recognition expands HSA’s WHO-Listed Authority (WLA) status to encompass all regulatory functions for all types of medicines, including generics, new chemical entities, biotherapeutics, and similar biotherapeutic products.
This accomplishment underscores HSA’s global reputation for high regulatory performance, ensuring that medicines in Singapore meet stringent safety, efficacy, and quality standards. It also highlights the national medicines regulatory agency’s commitment to continuous improvement and regulatory excellence.
HSA was among the first three regulatory authorities to be designated as a WLA in 2023. The other two regulatory authorities are the Ministry of Food and Drug Safety (MFDS) of South Korea and the Swiss Agency for Therapeutic Products (Swissmedic).
The WHO’s thorough assessment of HSA’s market surveillance and control involved evaluating core functions and operations, including the sampling and testing of market medicines to ensure safety and quality. This assessment was conducted from January 20 to April 9, 2024.
Dr. Choong May Ling, Mimi, Chief Executive Officer of HSA, expressed pride in the recognition, noting it as the culmination of HSA’s efforts to strengthen its regulatory system and align with international best practices. This achievement reinforces HSA’s commitment to providing safe, effective, and high-quality medicines to the public in Singapore.
As Singapore’s national medicines regulatory agency, HSA continuously upholds high standards and advances its regulatory performance. In January 2022, HSA achieved WHO Maturity Level 4, laying the groundwork for its WLA status. The WLA initiative by WHO aims to promote the availability of safe, effective, and quality medical products while optimizing global regulatory resources through reliance on trusted agencies’ decisions.
The recognition as a WLA enables greater confidence and reliance on HSA’s regulatory decisions, promoting trust in the global healthcare community.
HSA: Health Sciences Authority; WHO: World Health Organization; WLA: WHO-Listed Authority;
Adapted from: https://www.hsa.gov.sg/announcements/news/hsa-further-affirmed-by-WHO-for-its-medicines-regulatory-system
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