The World Health Organization (WHO) Awarded Singapore the highest recognition for an advanced Medicine Regulatory System
Singapore is the first WHO member state to achieve the status of Maturity Level (ML) 4, the highest level of attainment for a regulatory system classification, for its advanced medicines regulatory system.
The Health Sciences Authority (HSA) is the first National Regulatory Authority (NRA).
International assessors and WHO officials reviewed HSA Singapore in 2021 and conferred this prestigious recognition for an advanced level of performance and continuous improvement. “It means that HSA is recognized internationally as one of the most trusted and advanced regulators for medicines, contributing to public health outcomes in Singapore, the region, and beyond. 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,” said Mr. Ong Ye Kung, Minister for Health, Singapore.
Medical device stakeholders could expect similar regulatory standards applied. This recognition for HSA could expect the application of similar regulatory standards e.g. pre-market application review, post-market activities, for distributors of medical devices under the Medical Device Branch of Health Sciences Authority. In addition, HSAs Singapore Regulatory reliance for medical device registrations is also being established with some member states of AMDD.
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