关键词: 药物警戒, 信号, 药品上市许可持有人, 药品不良反应

Abstract:

The aim of this study was to provide insights into the current status and primary methodologies employed by marketing authorization holders (MAHs) for signal detection. These insights are intended to offer valuable references for regulatory authorities in shaping pertinent regulatory policies. We conducted purposive sampling interviews with personnel responsible for pharmacovigilance (PV) within MAHs, in accordance with “Good Pharmacovigilance Practice (GVP)”. The interviews covered six predefined topics with open-ended discussions, including signal collection, signal detection, signal evaluation, clustered signal detection, and current challenges and issues. A total of 26 MAHs were interviewed, comprising 14 foreign-owned and 12 domestic enterprises. Foreign-owned enterprises, along with some local innovative pharmaceutical companies, utilized Oracle’s Argus and Empirica for adverse drug reaction information storage and computer-aided quantitative signal detection, respectively. The majority of domestic enterprises used the Taimei system for data storage and qualitative analysis, although a few employed other systems. Foreign-owned MAHs had comprehensive drug vigilance systems, aligning with established standards such as those of the European Union and the United States. Domestic innovative MAHs had more comprehensive drug vigilance systems compared to traditional domestic MAHs. Their signal detection approaches drew inspiration from the practices of foreign MAHs. This work synthesized findings related to the state of PV practices within these MAHs, shedding light on the challenges, achievements, and potential pathways for improvement.

Key words: Pharmacovigilance, Signal, Marketing authorization holder, Adverse drug reactions