The PSUSA is a safety report required by the European Medicines Agency (EMA) for all human medicines from marketing authorisation holders. It includes information on the product’s safety profile, including any new safety concerns that have arisen since the product was first authorized. The PSUSA is submitted annually by the marketing authorisation holder and is specific to active substances of medicines.
Periodic safety update reports are used by regulatory authorities to evaluate the benefit-risk balance of a medicine throughout its lifecycle. PSURs help to identify new safety concerns and allow proactive risk management to minimise the potential for harm to patients.
The PSUSA is a single assessment of the PSUR data, submitted annually by the marketing authorization holder.
EMA is involved in PSUSA procedure to assess safety of medicines having same active substance or combinations.