Pharmacovigilance (PV) at regional level has become an important topic of discussion in PV audits and inspections. For all European Union (EU) countries, relevant requirements are defined in Good Pharmacovigilance Practices (GVP) and applicable regulations. Besides these common EU requirements, there are also local requirements that need to be followed and met. Of the 30 member states in the European Economic Area (EEA), national competent authorities in 22 member states require the nomination of a PV contact person at regional level/local Qualified Person Responsible for Pharmacovigilance (QPPV) based on the authorisation/marketing status of a medicinal product. Similarly, countries like Australia, Canada, Russia, and the Kingdom of Saudi Arabia require the nomination of a ‘QPPV’ equivalent residing in the respective territory.
It is essential that a consistent and efficient decision-making system should be developed at regional level, which empowers the local QPPV in safety assessment in alignment with global PV functions. Global PV oversight of regional PV activities is needed to achieve consistent patient safety.