Answer： According to the signal detection section of the "Quality Management Standards for Pharmacovigilance", holders should comprehensively summarize relevant information, evaluate the detected signals, and comprehensively determine whether the signals have constituted new drug safety risks. According to the risk assessment section of the "Quality Management Standards for Drug Vigilance", holders should promptly evaluate new drug safety risks, analyze influencing factors, describe risk characteristics, determine risk types, and evaluate whether risk control measures need to be taken. The evaluation should comprehensively consider the benefit risk balance of drugs. The purpose of signal detection is to promptly detect new drug safety risks. The process and methods include discovering potential drug safety signals through appropriate, scientific, and effective signal detection methods, and then evaluating the detected signals to comprehensively determine whether the signals have constituted new drug safety risks. For example, the reporting rate of two different events, leukopenia and abnormal liver function, was found to be high through signal detection. Therefore, further evaluation was conducted on these two potential signals, and it was found that leukopenia is related to underlying diseases and does not constitute a new drug safety risk. The signal evaluation ended; Suspicious liver function abnormalities are related to the use of drugs. If it is confirmed that a new drug safety risk has been identified, it is necessary to continue conducting risk assessments with higher-level personnel, such as the Drug Safety Committee. If a drug safety risk is identified, the influencing factors should be analyzed, risk characteristics should be described, risk types should be determined, and risk control measures should be evaluated. If it is currently unclear whether it is a drug safety risk, measures such as strengthening monitoring and continuous evaluation can usually be taken until the potential drug risk is qualitatively determined. So signal detection and risk assessment are two essential key business processes in the pharmacovigilance system, with a sequential order, but different objectives and process methods.