Chinese Journal of Pharmacovigilance ›› 2025, Vol. 22 ›› Issue (3): 282-285.
DOI: 10.19803/j.1672-8629.20240394

• Orginal Article • Previous Articles     Next Articles

Methods for Assessment of MAH Compliance with GVP

LIU Ying1, XIONG Shunyu,XIONG Huiyu1, CAI Fei1, XU Mengdan2, WANG Qing3,4, REN Wei3, XU Yan1,*   

  1. 1Center for ADR Monitoring of Guangdong, Guangzhou Guangdong 510080, China;
    2School of Pharmacy, Guangdong Pharmaceutical University, Guangzhou Guangdong 510006, China;
    3Research Center for Pharmacovigilance IT and Data Science, Tsinghua University, Beijing 100084, China;
    4Pharmacovigilance Research Center for information Technology and Data Science, Cross-Strait Tsinghua Research Institute, Xiamen Fujian 361015, China
  • Received:2024-06-17 Online:2025-03-15 Published:2025-03-17

Abstract: Objective To explore the methods for assessment of marketing authorization holders’ (MAHs) compliance with Good Pharmacovigilance Practice (GVP) and to design an informatized assessment tool according to applications in businesses so as to provide a reference for regulators’ efficient assessment of pharmacovigilance and for self-assessment by MAHs. Methods A system of indexes for assessment of MAHs’ compliance with GVP was developed as required by pharmacovigilance and related assessment. An informatized profiling model for MAHs’ pharmacovigilance was established via data analysis technology before the assessment methods were developed that were to be designed into assessment tools used across the province on a trial basis. Results Two hundred and ninety-nine key points of indexes for assessment and rating standards were identified, so the system and methods for assessment evaluation were established. Based on the actual operations, an informazed tool was devised and an informatized profiling model for assessment was established. Conclusion The establishment of methods for assessment of GVP compliance and informatized tools provides an innovative approach by which MAHs can improve their pharmacovigilance.

Key words: Marketing Authorization Holder(MAH), Good Pharmacovigilance Practice(GVP), Assessment of Compliance, Pharmacovigilance, Informatized Tool, Effective Supervision

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