Abstract: Objective To provide a reference for pharmaceutical groups to build a group pharmacovigilance system through reflecting on the key issues in building a group pharmacovigilance system. Methods Based on the good pharmacovigilance practices (GVP) and the experience of marketing authorization holders in establishing pharmacovigilance systems, the advantages, conditions and possible problems of a group pharmacovigilance system were discussed and suggestions on how to build a group pharmacovigilance system were made. Results The construction of a group pharmacovigilance system is conducive to maximizing resource utilization and improving the professional level of the group pharmacovigilance. Conclusion To meet the challenges brought by the implementation of GVP, pharmaceutical groups may consider establishing a group pharmacovigilance system based on their own situation.

Key words: pharmaceutical group, pharmacovigilance system, good pharmacovigilance practices