Processes of remote inspection of pharmacovigilance for marketing authorization holders

doi:10.19803/j.1672-8629.20220582

Abstract

Abstract: Objective To explore the normal processes of and considerations for remote inspection of pharmacovigilance for marketing authorization holders licensed by China's drug regulatory authorities. Methods The application of information tools and instruments in a particular part of remote inspection was discussed according to the on-site inspection workflow. Results and Conclusion Based on current information network technology, remote inspection of pharmacovigilance can achieve its purpose and help to improve efficiency, save time and costs, and identify and address drug safety issues earlier.

Key words: pharmacovigilance, Guidelines for Good Pharmacovigilance Practice(GVP), marketing authorization holder(MAH), inspection, remote

CLC Number:

R951

XIA Xudong, LI Meixia, SUN Yang, YANG Shengya. Processes of remote inspection of pharmacovigilance for marketing authorization holders[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 967-970.

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