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BMI expects Malaysia to see growing demand for clinical trials with launch of country's first-in-human trial

KUALA LUMPUR: BMI, a Fitch Solutions company, expects Malaysia to see an expansion of its clinical research facilities and capabilities with growing demand for local trials, following the launch of the country's first-in-human (FIH) trial for rheumatology in Malaysia.

Malaysia will be the seventh country included for Roche Pharmaceutical's study and the first within the Asia Pacific region, joining other global sites in Europe and South Africa.

"Seeing the success of major pharmaceutical companies like Roche, more drugmakers will choose to invest in clinical trials in Malaysia, boosting the country's pharmaceutical sector," BMI said in a note today.

The launch of Roche's global FIH trial for a rheumatology indication in Malaysia strongly affirms the country's burgeoning clinical research expertise.

It was achieved just two years after the successful completion of CRM Phase 1 Realisation Project (P1RP) in 2021, a pivotal initiative designed to foster the FIH trial ecosystem within Malaysia.

Since then, Malaysia has successfully undertaken one FIH and two First-in-Patient studies with Roche.

BMI said since the inception of CRM in 2012, Malaysia's clinical trial landscape has experienced remarkable growth, hosting over 2,300 sponsored clinical studies.

"The country is increasingly being recognised by drugmakers for its capacity to conduct multi-regional clinical trials, bolstered by world-class investigators, robust, well-established infrastructure and a stringent regulatory framework prioritising patient safety," BMI said.

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