In this first online issue of the NCCR bulletin, we cover the recently launched Malaysian GLP Compliance Programme (CP). The National Pharmaceutical Control Bureau (NPCB), Ministry of Health Malaysia and the Department of Standards Malaysia (STANDARDS MALAYSIA), Ministry of Science, Technology and Innovation, Malaysia are designated as the Malaysian Compliance Monitoring Authorities (CMAs) for this programme. In other clinical research developments, Collaborative Clinical Research Groups in specific clinical areas will be introduced to facilitate multi-centre studies. This would involve participation from all eligible institutions and investigators in Malaysia (or otherwise a nationally representative sample), from all sectors including the Ministry of Health, universities, as well as private and NGO healthcare organisations. We also discuss issues in bioequivalence studies, pharmacogenomics and traditional and complementary medicine as well as the progress made by our local web-based research registration system – National Medical Research Register.

NCCR bulletin editors

About NCCR

Established in 1997 to coordinate and encourage clinical trials in Malaysia, the National Committee for Clinical Research (NCCR) supports the enhancement and regulation of the quality of biomedical research as well as clinical research practice in Malaysia. The NCCR is headed by Tan Sri Dato’ Seri Dr Hj Mohd Ismail Merican, Director General of Health and it is managed by the Clinical Research and Compliance Section of the National Pharmaceutical Control Bureau, Ministry of Health Malaysia who acts as secretariat. The members of this committee consist of experts from Ministry of Health (MOH), various national Universities, the Malaysian Pharmaceutical Society (MPS), the Pharmaceutical Association of Malaysia (PhAMA), the Malaysian Organisation of Pharmaceutical Industries (MOPI), and other Non-Governmental Organizations.
www.nccr.gov.my