*Image is taken from The Straits Times
On October 26, 2023, the Health Sciences Authority (HSA) received recognition from the World Health Organization (WHO) as a WHO-Listed Authority (WLA) for its medicines regulatory system. This prestigious designation signifies that HSA operates at an advanced level of regulatory performance, ensuring that medicines in Singapore adhere to rigorous standards of safety, efficacy, and quality on a global scale.
HSA had previously achieved the WHO Maturity Level 4 in January 2022, based on operational efficiency. The subsequent assessment for WLA involved a comprehensive review of regulatory assessments, the scientific robustness of decision-making processes, and their consistent implementation. Conducted by a team of 10 international assessors and WHO officials from October 2022 to March 2023, this evaluation affirmed HSA’s excellence in core functions and operations.
The WLA initiative, established by WHO, aims to enhance access and supply of safe, effective, and quality medical products globally. It facilitates the optimal use of limited regulatory resources by allowing regulatory authorities to rely on decisions made by trusted agencies. The creation of a list of trusted WLAs promotes confidence and trust in authorities that have attained this global recognition.
Singapore’s status as a WLA not only contributes to global cooperation but also has the potential to attract pharmaceutical companies to choose Singapore as one of the primary markets for registering novel and innovative medicines. This could result in earlier access to groundbreaking medicines and treatments for patients in Singapore and stimulate growth in the health and biomedical sciences sector.
Dr. Choong May Ling, Mimi, Chief Executive Officer of HSA, expressed pride in the achievement, anticipating that HSA’s WLA status will enhance public confidence and trust in the organization’s efforts to safeguard public health. She looks forward to continued collaboration with WHO in strengthening regulatory systems.
Earlier last year, HSA Singapore has achieved a groundbreaking milestone by becoming the first National Regulatory Authority (NRA) worldwide, and Singapore is the first country in the World Health Organization (WHO) to attain Maturity Level 4 (ML4) for its advanced medicines regulatory system. This recognition, conferred by WHO, indicates that HSA operates at the highest level of regulatory performance, ensuring stringent standards for safety, quality, and efficacy of medicines in Singapore. The assessment, conducted by a team of 15 international assessors and 4 WHO officials using the WHO’s Global Benchmarking Tool, spanned from October 25 to November 5, 2021.
Attaining ML4 showcases HSA’s commitment to regulatory excellence, validating the organization’s high standards, quality, and rigor in ensuring the safety and effectiveness of approved medicines in Singapore. This achievement enhances public confidence by promoting transparency through the publication of assessment reports and validates HSA’s innovative post-market monitoring system, recognized by WHO for its effective use of data analytics to monitor adverse drug reactions associated with medicines and vaccines. The external validation by WHO positions HSA as a trusted and advanced regulator globally, contributing to public health outcomes in Singapore and beyond.
HSA: Health Sciences Authority; WHO: World Health Organization; ML4: Maturity Level 4; WLA: WHO-Listed Authority
Link to the original news article: https://www.hsa.gov.sg/announcements/news/hsa-whowla2023
Link to the pdf version: https://www.hsa.gov.sg/docs/default-source/default-document-library/hsaupdates_whowla_3nov23.pdf
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