The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs

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

March 24, 2017

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.

The group plans to develop new guidance on redaction of inspection reports and coordination between EU member states, as well as finalized guidance on specific therapies, and recommendations for inspectors verifying clinical trial compliance.

Work will continue on guidance on the use of data capture systems and risk-proportionate approaches in clinical trials.

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