HSA awarded WHO's highest recognition for advanced medicines regulatory system

SINGAPORE: The Health Sciences Authority (HSA) has been awarded the highest recognition for its advanced medicines regulatory system by the World Health Organization (WHO).

The HSA is the first national regulatory authority to achieve Maturity Level 4 (ML4), while Singapore is the first WHO member state to be awarded the same recognition, HSA announced in a media release on Monday (Feb 28). 

This is the highest level of attainment for a regulatory system classification system conferred to a national regulatory authority that has met the highest quality standards stipulated by WHO for regulatory excellence.

This achievement came after a "rigorous and comprehensive" assessment - which ran from Oct 25 to Nov 5 last year - by a team of 15 international assessors and four WHO officials using the WHO’s Global Benchmarking Tool, said HSA. 

This is made up of 251 indicators covering areas such as clinical trials, post-market safety monitoring and laboratory testing of medicines.

The status identifies HSA as an authority that is operating at an advanced level of "performance and continuous improvement", the agency said. 

"It validates the high standards, quality and rigour of HSA’s regulatory work in ensuring that medicines approved for use in Singapore are safe, of good quality and are effective for our population."

Prime Minister Lee Hsien Loong congratulated HSA for the recognition and said it is a validation of the "high standards, quality and rigour" of the authority's regulatory work.

"We benefited tremendously from HSA’s expedited evaluation process to review COVID-19 vaccines," said Mr Lee, adding that this allowed Singapore to roll out its vaccination programmes safely, efficiently and quickly.

Minister for Health Ong Ye Kung described the award as 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," said Mr Ong. 

He added people could now have even greater confidence in HSA’s assessments, and in their access to "high quality, safe and effective medicines". 

Attaining the ML4 requires that HSA publish its assessment reports detailing the safety, efficacy and quality of registered medicines and vaccines and their benefit risk analysis, said the agency, adding this would further enhance the transparency of its regulatory decisions.

HSA added that other international regulatory agencies can leverage its reports, which are available on the agency’s website, to facilitate their review of these products.

HSA said that WHO had also validated its "innovative post-market monitoring system" which uses data analytics as well as Singapore's electronic medical health records and extensive network of healthcare professionals, to monitor the adverse drug reactions associated with medicines and vaccines.

"This allows HSA to take swift actions to protect public health and safety," the agency said, pointing to its "quick and close monitoring" of the safety of COVID-19 vaccines and monthly release of safety reports as an example. 

"This external validation by WHO will enhance the Singapore public’s confidence and trust in HSA as an innovative and effective medicines regulator working to protect and advance their health and safety," the agency said. 

HSA said the WHO provided valuable feedback throughout its three-year benchmarking journey, coordinating the entire process and engaging a strong and experienced team of international assessors to undertake an extensive review of its regulatory processes and documentation.

Dr Mariangela Simao, WHO assistant director general for access to medicines and other health products, called this a "great achievement for Singapore".

"If countries want to improve health outcomes, if they want to expand local production, they first need to be able to ensure access to safe and quality medical products that actually work and benefit patients,” said Dr Simao.