White Paper

Post-Authorisation Non-Interventional Prospective Observational Safety Studies: Protocol Considerations

Source: UBC

By Dr. Janine Collins, MBBS, LLM, EU Safety, Epidemiology, Registries, and Risk Management and Jess Sohal, MSc, EU Clinical Operations

The 2010 EU pharmacovigilance legislation sets out clear provisions in relation to Post-Authorisation Safety Studies (PASS). These studies can be:

  • Imposed as an obligation as a condition of market authorisation (category 1)
  • Imposed as an obligation as part of a marketing authorisation granted under exceptional circumstances (category 2)
  • Managed or financed by a marketing authorisation holder voluntarily; including:
  • Studies required in the Risk Management Plan (RMP) to investigate a safety concern or evaluate the effectiveness of risk minimisation activities (category 3)
  • Any other PASS (category 4)