HSA is first health authority to reach WHO's top level for medicine regulatory system

It took three years for HSA to prepare for this ML4 rating. PHOTO: ST FILE

SINGAPORE - The Health Sciences Authority (HSA), the national regulator of health products in Singapore, has been recognised by the World Health Organisation (WHO) as having an advanced medicine regulatory system.

Out of 28 countries formally assessed by WHO, Singapore is the first to have achieved the highest level - what WHO calls maturity level ML4 - in its classification of regulatory authorities for medical products.

Amid the Covid-19 pandemic, HSA has been releasing monthly Covid-19 vaccine safety reports as it monitors the adverse drug reactions associated with the vaccines.

It said the system that it uses to monitor the reactions associated with medicine and vaccines has also been validated by this achievement.

It took three years for HSA to prepare for this ML4 rating, which came after an assessment by a WHO-led team of international experts that took place from late October to early November last year.

"This is great recognition of Singapore's achievement and very good news for the broader region," said Mr Martin Taylor, director of health systems and services in WHO's Western Pacific region and acting director for data, strategy and innovation, in a WHO press release.

"Singapore already helps several neighbouring countries to expedite their medicines assessments and this WHO classification may also encourage other countries and areas to continue strengthening their medicines oversight."

WHO evaluates the overall maturity of a country's medicine regulatory system on a scale of 1 (existence of some elements of a regulatory system) to 4 (operating at an advanced level of performance and continuous improvement).

It uses a global benchmarking tool, which has replaced all evaluation tools previously used by WHO. There are now seven countries on WHO's list of regulatory authorities operating at maturity levels 3 for different product scopes.

They include Ghana and Tanzania for medicine and vaccines (non-producing).

India, Indonesia, Serbia, Thailand and Vietnam are at this level for vaccines (producing).

Apart from ensuring the quality, safety and efficacy of medical products, regulatory authorities that function well also perform critical functions such as faster authorisation of products and drug safety monitoring after authorisation, said the WHO.

"Fewer than 30 per cent of the world's medicines regulatory authorities are considered to have the capacity to perform the functions required to ensure medicines, vaccines and other health products work and do not harm patients," it said in the release.

"For that reason, WHO has intensified efforts to bolster the capacity to regulate medical products in all regions and is working to strengthen regulatory networks where the most advanced regulatory authorities can act as lighthouses for regulators with fewer resources or which have not yet reached maturity."

Indeed, this rating requires HSA to publish its assessment reports detailing the safety, efficacy and quality of registered medicine and vaccines.

HSA said in its media release that other international regulatory agencies can then leverage its publicly available reports to facilitate their review of these products.

Health Minister Ong Ye Kung said the rating is a remarkable achievement for HSA.

"It means that HSA is recognised internationally as one of the most trusted and advanced regulators for medicines, contributing to public health outcomes in Singapore, the region and beyond," he said in a HSA release.

"The Singapore public will now have even greater confidence in HSA's assessments, and that they have access to high quality, safe and effective medicines."

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