EMA Updates Guideline on Good Pharmacovigilance Practice (GVP) Inspections

The European Medicines Agency (EMA) has revised its guideline on good pharmacovigilance practice (GVP) inspections. The update incorporates changes to rules regarding subcontractors of pharmacovigilance activities by marketing authorization holders, following an implementing regulation from the European Commission last year. The revised guidance clarifies that competent authorities can inspect third parties subcontracted for pharmacovigilance tasks, even if not explicitly stated in the subcontract. It also includes new advice on remote inspections and pre-authorization inspections.