Common Problems with Post-marketing Adverse Drug Reaction Reports from Literature

doi:10.19803/j.1672-8629.2021.12.12

Abstract

Abstract: Objective To summarize problems with post-marketing adverse drug reaction (ADR) reports collected from literature in China and give related advice to marketing authorization holders (MAHs).Methods The common problems with ADR reports from related literature were listed and analyzed. Suggestions for improvement were offered based on the requirements of relevant guidelines and documents issued by the NMPA after 2018 and the requirement of ICH E2D guideline. Results and Conclusion The ADR reports collected from related literature are imperfect in terms of compliance, completeness and timeliness, and MAHs need to make more efforts to improve the quality of such reports.

Key words: adverse drug reaction, individual case safety reports, literature search

CLC Number:

R951

ZHU Lan, ZHU Yan, LIU Lihong, SHAO Bo, LIU Hongliang, XIONG weiyi. Common Problems with Post-marketing Adverse Drug Reaction Reports from Literature[J]. Chinese Journal of Pharmacovigilance, 2021, 18(12): 1155-1158.

References

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