FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

EMA’s GCP Working Group Outlines Inspection Priorities, Planned Guidances

Feb. 28, 2017
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The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections.

Coverage will increase for sites related to novel drug and generics applications being submitted to both the EMA and the FDA.

The EU agency’s GCP inspection program plans to focus on indications, patient populations and the size of the sponsors, as well as on the location of sites and study recruitment rates.

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