FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

MHRA Flags Fewer Critical Pharmacovigilance Findings in Inspections

Dec. 8, 2017

The UK’s Medicines and Healthcare products Regulatory Agency reported fewer critical findings in its annual pharmacovigilance inspection report covering April 2016 to March 2017 — logging just six critical findings compared to 11 in the previous year.

Two critical findings related to signal management. Others cited a failure to establish a global pharmacovigilance system, inadequate pharmacovigilance oversight, and failing to maintain reference safety information.

The agency identified 150 major findings in the 36 inspections during the period. The largest number of major noncompliance issues related to quality assurance, the quality system, reference safety information, case processing, the pharmacovigilance system master file, and adverse events.

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