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(2004; 88 pages)
The objective of the Malaysian GCP guideline is to ensure that drug-related trials in Malaysia are conducted in accordance with international ethical and scientific standards. It details the quality processes required in the conduct of clinical trials to ensure that human subjects participating in the trials are protected and that studies so conducted are based on good science and are well-designed. Also, the results arising from the trials are properly recorded, analyzed and reported. Strict adherence to this guideline will facilitate the mutual acceptance of clinical data by international regulatory authorities, especially since the guideline adopts the basic principles outlined by the International Committee on Harmonization of Good Clinical Practice (ICH-GCP) albeit with some modifications to suit the local requirements.