Singapore is the first country in WHO’s categorization of regulatory authority for medical goods to obtain the highest maturity level (ML 4) out of 28 nations formally examined. With ML 4, Singapore is one step closer to being a WHO listed authority, a new programme that will go live later this year and identify all of the world’s reference regulators.
Martin Taylor, WHO Western Pacific Region Director of Health Systems & Services and interim Director for Data, Strategy & Innovation, stated that this was a fantastic acknowledgement of Singapore’s performance and extremely positive news for the larger region. Singapore currently assists a number of neighbouring nations in expediting their drug evaluations, and this WHO categorization may motivate other governments and regions to continue boosting their medicine supervision.
Medical product regulation is critical for all health systems and for ensuring access to high-quality vaccinations, medications, and other health supplies. Regulatory bodies that work well do important things like speed up product approval and keep an eye on drug safety after it’s been approved. They also make sure that medical products are safe, effective, and high-quality.
The WHO assesses regulatory agencies using the “Global Benchmarking Tool”, an assessment method that compares regulatory functions to over 260 indicators covering key regulatory tasks such as product licensing, testing, market surveillance, and the ability to detect hazardous occurrences. After subsequent performance evaluation, regulatory bodies that attain maturity levels 3 and 4 will be considered appropriate for inclusion on the WHO list.
A WHO-led team of foreign specialists benchmarked Singapore’s Health Sciences Authority (HSA). The Authority was evaluated by WHO in late 2021 and judged to be performing well on the International Benchmarking Tool’s indicators. According to Dr Choong May Ling, Mimi, Chief Executive Officer of Singapore’s Health Sciences Authority, they are proud to have attained maturity level 4 in the recent WHO international benchmarking review. With this, Singapore is the first WHO Member State to achieve the highest degree of maturity for its medicine regulation system. He adds that this success will improve public faith in the system. All thanks to their excellent engagement with WHO, they are confident that HSA will maintain their culture of operational excellence and continual progress.
On estimates, less than 30% of the world’s pharmaceutical regulatory authorities can effectively monitor the safety of medicines, vaccines, and other health products. As a result, WHO is trying to strengthen regulatory networks so that the most advanced regulatory agencies can act as beacons for authorities with fewer resources or ones not yet mature.
WTO Assistant Director General for Access to Medicines and Other Health Products Mariângela Simo said the organization’s work is focused on empowering countries to enhance access to health services for their citizens. She adds that if countries want to enhance health outcomes, solve health emergencies, and grow local production, they must first ensure access to safe, effective medical products.
