FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

TGA Lists Pharmacovigilance Deficiencies in First Inspection Metrics Report

April 4, 2019
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Some Australian drugmakers are still figuring out how to pass muster during the Therapeutic Goods Administration (TGA)’s new pharmacovigilance inspections introduced in 2017, according to the TGA’s first metrics report.

The agency’s inspectors found no “critical” deficiencies during inspections in 2018, but they logged a total of 50 “major” deficiencies in ten routine inspections. Major issues included 12 related to the “collection and collation” of adverse drug reactions, ten related to the management of reference safety information and nine related to the management of significant safety issues and adverse drug reactions.

Other major findings related to quality management systems, pharmacovigilance contact individuals, risk management and “other post-approval commitments.”

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