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The spontaneous Adverse Drug Reaction (ADR) reporting system is considered the most important method of collecting and monitoring information pertaining to drug-related safety issues. Described as the simplest and most cost-effective method of ADR reporting, spontaneous reporting is a major source of information within pharmacovigilance. The Malaysian pharmacovigilance system administrated by the Malaysian Drug Control Authority (DCA), through the Malaysian Adverse Drug Reaction Advisory Committee (MADRAC), has been in operation for more than twenty-five years.