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.
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