List of important organisations

(Click on each of the links for contact details)

University Malaya Medical Centre Medical Research Ethics Committee (UMMC MREC) – an institutional REC that provides ethical guidance and review for medical research involving human subjects in UMMC / University of Malaya (UM).


University Malaya Research Ethics Committee (UM REC) – an institutional REC that provides ethical guidance and review for non-medical research involving human subjects in UM.


UMMC Clinical Investigation Centre (CIC) – a centre that supports clinical trials in UMMC through the provision of human resource, facilities, financial advice, legal advice and education / training (including GCP training).


Malaysia National Institute of Health (NIH) – an institute under the Ministry of Health (MOH) Malaysia that manages all health research activities in MOH institutions. Also provides grants.

• National Medical Research Register (NMRR) – an online registry set up by the NIH. All research that involves MOH personnel or MOH facilities, or funded by a MOH research grant, has to be registered on NMRR. Also serves as a portal for NIH ethics and grant application. Although UMMC is not under MOH, UMMC MREC requires all clinical trials in UMMC to be registered on NMRR.
  
  
• NIH Medical Research and Ethics Committee (MREC) – Research ethics committee of the NIH. Provides ethical guidance and review for human subject research that involves MOH patients, staff or facilities. May also act as an Independent Ethics Committee for non-MOH institutions. Application to the MREC is done through the NMRR website.
  
  

National Committee for Clinical Research (NCCR) – a committee that establishes the guidelines and policies for clinical research in Malaysia. Also conducts GCP training for researchers.


National Pharmaceutical Regulatory Agency (NPRA) – the regulatory body that is responsible for overseeing drug trials, monitoring the adverse reactions of drugs and registering new drugs in Malaysia. Products regulated by the NPRA include natural / herbal products, health supplements, generic medicines and biologics (vaccines, cell products, gene therapy products, etc.)


Medical Device Authority (MDA) – the regulatory body that is responsible for overseeing research on medical devices, monitoring the safety of medical devices and registering new medical devices in Malaysia. See ‘Definition of medical device’ (2014).

List of international guidelines →