Regulatory Update | HSA Singapore Achieves Maturity Level 4 (ML4) For Advanced Drug Control Systems by The World Health Organization

The Health Sciences Authority (HSA) of Singapore has reached Maturity Level 4 (ML4) in advanced drug regulatory systems. ML4 represents the highest level of achievement in the classification of regulatory systems, awarded by the National Regulatory Authority (NRA) that meets the stringent quality standards set by the World Health Organization (WHO) for regulatory excellence.

This significant achievement was the result of a rigorous assessment conducted from October 25 to November 5, 2021. The WHO engaged 15 international assessors and 4 officials who utilized the WHO's Global Benchmarking Tool, which includes 251 comprehensive indicators to validate the performance of the regulatory system across 8 core regulatory functions. Notably, HSA is the first WHO member country to attain ML4 for a sophisticated drug regulatory system.

As part of this achievement, the HSA is required to publish a report detailing its assessment of reaching ML4, which will cover the safety, efficacy, and quality of the listed drugs and vaccines, as well as a risk-benefit analysis. The ML4 status signifies that the HSA operates with advanced performance and a commitment to continuous improvement. This reflects the authority's rigorous auditing capabilities to ensure that pharmaceuticals manufactured comply with international standards, guaranteeing that medicines approved in Singapore are of high quality, safe, and effective.

HSA's benchmarking journey has spanned three years, during which the WHO provided feedback through an extensive review of regulatory and documentation processes involving an international assessment team. Dr. Mariângela Simão, WHO Assistant Director-General, remarked, "This is a huge achievement for Singapore." The attainment of ML4 is expected to enhance public trust and confidence in the HSA as an innovative and effective pharmaceutical regulator dedicated to protecting and promoting public health. Additionally, HSA has gained international recognition as one of the most trusted and leading regulators for pharmaceuticals.

The HSA employs data analytics and leverages national electronic medical health records along with an extensive network of healthcare professionals to monitor adverse drug reactions associated with drugs and vaccines. This capability allows the HSA to take swift action to protect public health and safety.

WHAT IS Maturity Level 4 (ML4)?

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

Health Sciences Authority

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

Source:
HSA Press Release