KUALA LUMPUR – The National Pharmaceutical Regulatory Agency (NPRA) has highlighted the needs for a healthy research volunteer register for clinical trials in Malaysia as enshrined in the Malaysian Guideline for Phase 1 Unit Inspection and Accreditation Programme 2018.
Director-General of Health Tan Sri Dr Noor Hisham Abdullah said, it is in line with the international standards and the precedence in monitoring the safety of healthy volunteers in clinical trials.
“Clinical trials consist of several phases such as Phase 1, Phase 2, Phase 3 and Phase 4. Generally, the clinical trials are conducted with the involvement of patients or healthy volunteers,” he said.
Noor Hisham said, healthy volunteers are those without any health problems that hinder them from joining clinical trials.
Specifically, the healthy volunteers are involved in Phase 1 of clinical trials, bioavailability and bioequivalence studies and Phase 3 researches such as the ongoing clinical research on vaccine.
To ensure that the platform is effective, trainings have been given to the staff of the clinical research centre network under the management of the Institute of Clinical Research (ICR), Ministry of Health (MOH) and institutions or centres conducting the bioavailability and bioequivalence based clinical trials.
He added, the MOH also targets thorough involvement from higher learning institutions and the private sector to use the platform in the future.
Noor Hisham officiated the virtual launch of the National Healthy Research Volunteer Register today. – MalaysiaGazette
