Chinese Journal of Pharmacovigilance ›› 2023, Vol. 20 ›› Issue (9): 978-981.
DOI: 10.19803/j.1672-8629.20230247

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Exploring the significance of collecting patient reports based on international pharmacovigilance experience

PANG Yu1, LIU Bo2,Δ, LYU Shaoli1, WANG Tao3, XING Ying1, QIN Xingyu1, TIAN Yuejie4,*, WU Wenyu5#   

  1. 1Remegen, Yantai Shandong 265503, China;
    2Institute for Chemical Drug Control, National Institutes for Food and Drug Control, Beijing 102629, China;
    3Center for Drug Reevaluation, NMPA/NMPA key Laboratory for Research and Evaluation of Pharmacovigilance, Beijing 100022, China;
    4Shandong Center for ADR Monitoring, Ji'nan Shandong 250014, China;
    5Shenzhen Institute of Pharmacovigilance and Risk Management, Shenzhen Guangdong 518024, China
  • Received:2023-04-21 Online:2023-09-15 Published:2023-09-14

Abstract: Objective To explore the significance of enterprises collecting patient reports as stated in Good Pharmacovigilance Practice (GVP). Methods Review the literature about the research findings from various nations and discuss the value of patient reports to reveal the importance of collecting patient reports. Results and Conclusion Patient reports are a beneficial supplement to doctor reports and are conducive to signal detection. Enterprises should take patient reports seriously, establish paths for collecting patient reports, and ensure the paths work efficiently.

Key words: patient reports, pharmacovigilance, adverse drug reaction, good pharmacovigilance practice, marketing authorization holder

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