Purpose of the PSUR

PURPOSE OF THE PSUR

The PSUR creates the opportunity for a periodic overall safety evaluation to show whether a product’s safety profile has remained the same or has undergone change since it was authorised and to indicate whether changes should be made to product information to optimise the use of a product. The reason such a review is needed periodically is because clinical trials tend to be of short duration and to include a limited number of patients. Moreover, clinical trials have inclusion and exclusion criteria. After a product is launched, it may be used by patients not studied in clinical trials, for example children, the elderly, pregnant or breastfeeding women or patients with comorbidities such as hepatic or renal disease. After approval, a drug becomes so available for immediate use in large populations, so rare adverse drug reactions (ADRs) can be more easily identified. The drugs also become available for indefinite use (unless prescribing information indicates otherwise), and delayed onset ADRs become easier to identify.