REGULATORY UPDATE | HSA SINGAPORE HAS ACHIEVED Maturity LEVEL 4 (ML4) FOR ADVANCED DRUG CONTROL SYSTEMS BY THE WORLD HEALTH ORGANIZATION

The Health Sciences Authority (HSO), has reached maturity level (ML) 4 in advanced drug regulatory systems. ML4 is the highest level of achievement in the classification of regulatory systems awarded by the NRA that meets the highest quality standards set by the WHO for regulatory excellence.

This achievement was obtained after going through a very strict assessment that took place from October 25 to November 5, 2021. In this assessment WHO brought in 15 international assessors and 4 Officials from WHO who used WHO's Global Benchmarking Tool which consisted of 251 comprehensive indicators and validate the performance of the regulatory system which includes 8 core regulatory functions. HSA is the first World Health Organization (WHO) member country to achieve Maturity level (ML) 4 for a sophisticated drug regulatory system.

The HSA must publish a report on its assessment of achieving ML4 detailing the safety, efficacy and quality of the listed drugs and vaccines as well as a risk-benefit analysis. This ML4 status indicates that the HSA is an NRA with advanced operating performance and continuous improvement, as well as the HSA's rigorous auditing capabilities to ensure the manufacture of quality pharmaceuticals in compliance with international standards. This ensures that medicines approved by Singapore are of good quality, safe and effective.

HSA has been benchmarking for 3 years and throughout the journey WHO provided feedback in the form of conducting an extension review of the regulatory and documentation process involving an international assessment team. WHO Assistant Director General Dr Mariângela Simão said "this is a huge achievement for Singapore". With ML4 this will increase Singaporean Public Trust and Confidence in HSA as an innovative and effective pharmaceutical regulator that works to protect and promote public Health. Not only Singaporeans, HSA has also been internationally recognized as one of the most trusted and leading regulators for pharmaceuticals.

HAS uses data analytics and leverages national electronic medical health records and an extensive network of care professionals for a post-market monitoring system to monitor adverse drug reactions associated with drugs and vaccines. That way HSA can take swift action to protect public health and safety.

WHAT Maturity Level is (ML4) 4

ML4 is the highest level of achievement for a regulatory system classification system awarded to an NRA that has met the highest quality standards set by WHO for regulatory excellence.

Health Sciences Authority

The Health Sciences Authority is a multidisciplinary authority that serves as the national regulator for health products and ensures they are regulated wisely to meet safety, quality and efficacy standards. As a national blood service, it is responsible for providing a safe and adequate blood supply.

Source:https://www.hsa.gov.sg/announcements/press-release/who-ml4