EMA revises GVP inspection guideline to incorporate new subcontractor rules

The European Medicines Agency has issued an update to its guideline on good pharmacovigilance practice inspections. The revision aligns the guidance with recent changes to the rules governing subcontractors involved in pharmacovigilance activities.

The updated guideline clarifies expectations for both sponsors and their subcontractors, aiming to ensure consistent oversight during inspections. It reflects the EMA’s effort to keep regulatory frameworks current with industry practices.

Stakeholders are advised to review the new provisions to remain compliant with the revised inspection standards.