After additional performance evaluation, regulatory authorities that reach maturity levels three and four will be deemed eligible for inclusion among WHO-listed authorities.
Singapore is the first country to reach the highest maturity level (ML 4) in WHO’s classification of regulatory authority for medical products, out of 28 countries formally reviewed by the World Health Organization (WHO). The achievement of ML 4 moves Singapore closer to being a WHO-listed authority, a new scheme that will go live later this year and identify the world’s reference regulators, according to a statement from WHO.
“This is a wonderful recognition of Singapore’s accomplishments and excellent news for the region as a whole.” “This WHO classification may also motivate other nations and localities to continue increasing their medicines oversight,” said Martin Taylor, WHO’s Western Pacific Region Director of Health Systems and Services and acting Director for Data, Strategy, and Innovation in a statement.
Medical product regulation is critical for all health systems and access to high-quality vaccinations, medications, and other health items. Regulatory authorities that work well not only ensure the quality, safety, and efficacy of medical products, but also provide vital functions such as speedier product approval and drug safety monitoring following approval, according to the statement.
It also stated that WHO’s evaluation of regulatory authorities is based on the ‘Global Benchmarking Tool,’ which is an evaluation tool that compares regulatory functions to a set of over 260 indicators – covering core regulatory functions such as product authorisation, product testing, market surveillance, and the ability to detect adverse events – to determine their maturity and functionality. After additional performance evaluation, regulatory authorities that reach maturity levels three and four will be deemed eligible for inclusion among WHO-listed authorities.
A WHO-led team of international specialists conducted the benchmarking of Singapore’s Health Sciences Authority (HSA). The WHO conducted a formal evaluation of the authority in late 2021, and the HSA was deemed to perform well against the Global Benchmarking Tool’s metrics, it added.
“The Singapore Health Sciences Authority is proud to have reached maturity level four in the World Health Organization’s recent worldwide benchmarking review. As the first WHO member state to achieve this highest degree of maturity for our pharmaceuticals regulatory system, this achievement is a significant milestone and confirmation for Singapore. This success, I believe, will increase public confidence and faith in the system. In a statement, Dr. Choong May Ling, Mimi, Chief Executive Officer, Singapore’s Health Sciences Authority, said, “I look forward to HSA maintaining our culture of operational excellence and continuous improvement, as well as continuing our strong collaboration with WHO in regulatory system strengthening.”
It also stated that just around 30% of the world’s pharmaceuticals regulatory authorities are deemed capable of performing the responsibilities necessary to ensure that medicines, vaccines, and other health goods work and do not harm patients. As a result, WHO has stepped up efforts to build regulatory capacity in all regions and is trying to strengthen regulatory networks in which the most advanced regulatory authorities can serve as lighthouses for regulators with fewer resources or who have not yet matured.
“At the heart of WHO’s work is empowering countries through support and knowledge sharing so that they can improve access to health care for their people.” In a statement, Mariângela Simo, WHO Assistant Director-General for Access to Medicines and Other Health Products, said, “If countries want to improve health outcomes, address health emergencies, and expand local production, they must first be able to ensure access to safe and quality medical products that actually work and benefit patients.”
