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The QMN Weekly Bulletin

EMA Increased GCP Inspections in 2016

Sept. 1, 2017

The European Medicines Agency conducted 15 percent more inspections for compliance with good clinical practices in 2016 than in 2015, the agency reported.

GCP inspections increased from 396 in 2015 to 459 in 2016, and inspections within the EU and European Economic Area accounted for more than 89 percent of the total.

Of the total inspections in 2016, 85 were requested by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The CHMP-requested inspections resulted in citations for 1,033 deficiencies, with 93 considered critical, 558 major and 382 minor.

Areas that generated the most deficiencies included “essential documents,” “monitoring,” and “reporting.”

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