Thoughts on design and quality management of active safety surveillance research of traditional Chinese medicine injections initiated by Marketing Authorization Holder

doi:10.19803/j.1672-8629.2022.09.13

Abstract

Abstract: Objective To provide ideas for MAH to carry out the research design and quality management of active safety monitoring of traditional Chinese medicine injections. Methods It analyzed the characteristics and causes of adverse reactions of traditional Chinese medicine injections, drawing lessons from the current status of active safety surveillance in literature research and the experiences of Spontaneous monitoring, and it put forward suggestions on the research design and quality management of active safety surveillance in MAH. Results The design elements of active safety surveillance included comprehensively investigating policy and product related information, determining the factors related to the target population, collecting comprehensive usage information, setting evaluation indicators to achieve the objectives of active monitoring research, designing standardized and completed data collection tables, and selecting scientific and appropriate data management and analysis methods. The quality management of active surveillance research included establishing a research team with clear rights and responsibilities, setting a standard operating process and strengthening personnel training, selecting an appropriate data management system, and making full use of centralized monitoring technology. Conclusion Active safety surveillance is one of the effective ways to find safety risk signal of traditional Chinese medicine injections, and it also can provide evidence for risk signal review and validation.

Key words: Chinese medicine injection, active safety surveillance, research design, quality management, marketing authorization holder(MAH)

CLC Number:

R994.11

ZHONG Lumiao, DU Juan, DENG Hua, WANG Yafeng, QIU Ping, ZENG Linggui. Thoughts on design and quality management of active safety surveillance research of traditional Chinese medicine injections initiated by Marketing Authorization Holder[J]. Chinese Journal of Pharmacovigilance, 2022, 19(9): 994-998.

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