SG slashes clinical trial red tape, speeds up health tech reviews

It is due to launch early next year.

Singapore will halve approval timelines for selected lower-risk Phase Three clinical trials to 15 days, Health Minister Ong Ye Kung announced.

The change will sit under a common entry point for clinical research and regulatory engagement, due to launch early next year.

Starting in November, the Health Sciences Authority (HSA) and the Agency for Care Effectiveness will set up a Priority Track for health technology assessment (HTA) of selected innovative health products.

The two agencies will run their reviews concurrently, and the time to the first HTA decision is meant to fall to six to nine months from about one year.

Moreover, a law passed last month will bring three regulatory domains under HSA, including health products, which it already oversees, plus the Ministry of Health’s functions covering healthcare services, health information, human biomedical research and biosafety, and the Secretariat of healthcare Professional Boards.

HSA will also set up a Healthcare Industry Advisory Council in the first half of next year.

Internationally, HSA and the United Kingdom’s Medicines and Healthcare products Regulatory Agency have also set up a Regulatory Innovation Corridor to speed patient access to new therapies, including those developed with artificial intelligence.

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