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Question: Can the investigation of individual death cases not go through the Drug Safety Committee? Can relevant departments conduct a joint investigation?
Answer: According to the Guiding Principles for Collection and Reporting of Adverse Drug Reactions in Individual Cases, 7.2 Death Case Investigation: Holders should investigate the known death cases and complete the investigation report and submit it within 15 calendar days. The investigation includes verifying, supplementing, and improving information on death cases, drug use, adverse reactions, and diagnosis and treatment; Understand the storage and dispensing environment of drugs, as well as the occurrence of similar adverse reactions, from medical institutions; If the patient is transferred to another hospital for treatment, the relevant situation of the transfer should be investigated. In addition, data such as patient medical records and autopsy reports should be collected based on the actual situation. During the process, the quality management department is also required to assist in reviewing product quality and conducting quality related investigations if necessary. The current regulations do not specify whether individual death investigation reports must be reviewed by the Drug Safety Committee. According to Article 20 of the "Quality Management Standards for Drug Vigilance", the Drug Safety Committee is responsible for major risk assessment, handling of major or emergency drug events, risk control decisions, and other major matters related to drug vigilance. Whether a single death case belongs to a significant risk should be combined with product safety characteristics. If it is determined that this death case will cause significant potential harm to patients or the public and is classified as a significant risk, it needs to be reviewed by the Drug Safety Committee. Please determine based on comprehensive factors such as company processes and product safety characteristics.