MHRA GPvP Report: Areas with Critical Findings in Risk Management
The Medicines and Healthcare products Regulatory Agency (MHRA) Good Pharmacovigilance Practice (GPvP) inspectorate in the United Kingdom recently published their latest inspection metrics for the period from April 2019 to March 2020.
All critical findings were in the area of risk management, which is quite consistent with the previously published results, specifically:
▪ 3 in relation to maintenance of reference safety information
▪ 1 in relation to implementation of additional risk minimization measures
▪ 1 in relation to management of additional pharmacovigilance activities in Part III of the risk management plan (RMP)
Ref: Medicines and Healthcare products Regulatory Agency. Pharmacovigilance inspection metrics report, April 2019-March 2020. Published February 26, 2021. Accessed April 5, 2021. https://www.gov.uk/government/statistics/pharmacovigilance-inspection-metrics-2009-to-present
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