PETALING JAYA, Oct 16 — Universiti Malaya Medical Centre (UMMC) has reached a new milestone in clinical research with the establishment of its Phase I Unit, which will conduct early-stage drug and device trials under hospital conditions.

The facility, located at the UMMC’s Clinical Investigation Centre (CIC), is the first of its kind in a Malaysian teaching hospital and is designed for First-in-Human and Phase I studies focusing on safety, tolerability and dosage.

UMMC Hospital Director Professor Dr Nazirah binti Hasnan said the unit strengthens the hospital’s role in training doctors, researchers and students, giving them invaluable hands-on experience in the complexities of early-phase clinical research.

“For patients, it means the possibility of accessing innovative treatments much earlier, in a safe and closely monitored environment,” she said

Purpose-built with 10 clinical beds, two observation rooms and 24-hour medical oversight, the unit will operate as a self-contained “mini hospital” with access to emergency and specialist services.

It also includes an in-house pharmacy with controlled drug storage and a Class II Biological Safety Cabinet for sterile handling of investigational products.

Oncology will serve as the flagship specialty, though the unit is also capable of supporting studies in rheumatology, neurology, haematology, respiratory medicine, nephrology and cardiology.

Head of the CIC Professor Dr Lim Soo Kun said the facility was designed to meet all requirements of early-phase trials, from drug handling to patient monitoring.

The unit is currently moving toward accreditation by the National Pharmaceutical Regulatory Agency (NPRA) and is expected to be fully operational for clinical studies in 2026.