1. Post-Authorisation Safety Studies (PASS)


2. Aims of a Post-Authorisation Safety Study (PASS)

The main aims for initiating a PASS should include any of the following objectives:

  • to quantify potential or identified risks, e.g., to characterise the incidence rate, estimate the rate ratio or rate difference in comparison to a non-exposed population or a population exposed to another medicinal product, and investigate risk factors, including effect modifiers;
  • to evaluate the risks of a medicinal product used in a patient population for which safety information is limited or missing (e.g., pregnant women, specific age groups);
  • to evaluate the risks of a medicinal product after long-term use;
  • to provide evidence about the absence of risks;