Pharmacovigilance impact research (PIR), as an important application field of pharmacoepidemiology, has attracted continuous attention in recent years from drug regulatory authorities, pharmaceutical manufacturers, and the academic community both domestically and internationally. This paper provides an interpretation of PIR based on the Guide for Methodology in Pharmacoepidemiologic Research (2nd edition). First, an overview of the implications of PIR will be provided, focusing on the pathways of pharmacovigilance activities and the significant importance of conducting PIR. Second, it reviews commonly used study designs and presents illustrative case examples. Building on this, the specific statistical considerations relevant to PIR were discussed. Finally, the challenges and prospects of conducting pharmacovigilance impact studies in a scientific and standardized manner are summarized. Compared with the previous edition, the 2nd edition has expanded the application scenarios of pharmacoepidemiology to include new areas such as PIR. Drawing on the guideline content and practical experience, this paper provides a detailed introduction and case analysis of PIR, serving as a reference for researchers engaged in this field.

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