Singapore plans to cut approval time for certain trials to 15 days — Channel NewsAsia
Singapore plans to speed up the regulatory review of healthcare innovations to become one of the region’s most trusted and efficient hubs for clinical research and evidence generation. Health Minister Ong Ye Kung announced the measures on October 12, Channel NewsAsia reports.
According to the minister, the Health Sciences Authority of Singapore (HSA) will expand its role across the entire chain of developing and implementing medical innovations — from clinical development and regulatory assessment to health technology assessment and patient access to new products. Currently, companies have to engage with several government bodies while moving from research to clinical development, regulatory assessment and patient access.
Parallel product assessment
HSA and the Agency for Care Effectiveness (ACE) will create a priority mechanism for selected medical products. It will make it possible to conduct regulatory assessment and health technology assessment simultaneously.
Singapore will also cooperate with the United Kingdom under a new regulatory innovation corridor. It will consider breakthrough treatments, including those involving the use of artificial intelligence in drug development and clinical trials.
It is estimated that these initiatives, together with HSA’s plan to streamline regulatory review, could reduce the approval time for certain lower-risk Phase III clinical trials from 30 to 15 days. The time to the first decision on health technology assessment could also be reduced from about one year to six to nine months after regulatory approval.
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Integrated regulator
Key regulatory areas will also be placed under HSA’s oversight to create a clearer system for assessing medical innovations. In September, parliament passed a law designating HSA as an integrated healthcare regulator.
At the first stage, from November 1, 2026, the regulatory functions and staff of the Ministry of Health will be transferred to HSA. At the second stage, by the end of 2027, HSA is to take over the functions and staff of the Secretariat of the Medical Professional Boards.
Ong Ye Kung explained that the boundaries between medicines, medical devices, services, professionals and medical information are becoming less distinct. As examples, he cited AI-based medical devices, AI-enabled medical services and doctors using such technologies: different rules and laws may currently apply to them.
By the first half of 2027, HSA will also establish a Healthcare Industry Advisory Council. It will bring together industry representatives to identify emerging opportunities and risks, as well as provide recommendations on the competencies needed in medical innovation.
