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Pharmaceuticals / Inspections and Audits

EMA Conducting Fewer GMP But More GCP and Pharmacovigilance Inspections

May 7, 2018

The EMA noted a steep decrease in GMP inspections in its annual report for 2017, as well as a hike in inspections for good clinical practices and nearly double the amount of pharmacovigilance inspections than the previous year.

The agency conducted 672 GMP inspections in 2016, but only 397 in 2017. It attributed the decrease to the implementation of the EU-US’ mutual recognition agreement, which saw the FDA and EMA shift their focus to conducting GMP inspections solely within their respective countries when possible.

Less than 1% of the GMP inspections conducted in 2017 led to the issuing of a non-compliance statement, EMA said.

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