The principle reason for conducting pre-clinical studies is to insure the safety of human subjects in trials testing investigational drugs，particularly early in development，as there is no benefit to mitigate the risk imposed on normal volunteers． In this paper，the roles of pathology in pre-clinical safety testing of new drugs are discussed respectively from the two phases of drug development． involving knowledgeable Pathologists within risk management teams，for assisting and monitoring drugs development，may be the key to successfully developing and articulating a wellconducted risk management strategy．