This website uses cookies so that we can provide you with the best user experience possible. Cookie information is stored in your browser and performs functions such as recognising you when you return to our website and helping our team to understand which sections of the website you find most interesting and useful.
Post-Authorization Safety Study (PASS)
Post-Authorization Safety Study (PASS)
A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming principally to further evaluate the safety of the medicinal product or to measure the effectiveness of risk-management.
Post-Authorization Safety Study
PASS refers to studies performed after marketing authorization of a medicinal product conducted with the intention of identifying, further characterizing or quantifying a safety hazard. The final aim would be to confirm the safety profile of the medicinal product or evaluate the efficiency of risk minimization measures.
PASS in the European Union
According to the EMA guideline on good pharmacovigilance practices, a PASS may be initiated, managed or financed by an MAH voluntarily, or pursuant to an obligation imposed by a competent authority. A PASS can be imposed during evaluation of initial MAA or during PA phase whenever there are concerns on risks.