Within all European pharmacovigilance there are set steps that must be taken to report drug safety data to the regulatory authorities. Periodic Safety Update Reports (PSURs) are at the heart of the system. Pharmaceutical companies are obliged to provide them by law for each medicine. This article provides a brief overview of their key characteristics.

When pharmaceutical companies wish to bring any medicine (drug or otherwise medicinal product) onto the European market, they must apply for official permission. This comes in the form of a Marketing Authorisation. Part of the agreement made in effect when a Marketing Authorisation is granted is the submission of regular PSURs on an ongoing basis. Very broadly speaking, they function as an update of all that is known about the medicine’s safety profile during a particular period of time. They help regulators to build up a picture of whether it is safe on balance to continue to place the medicine on sale.

PSURS are not the only mechanism by which the regulators must be informed of adverse events for a particular medicine. Nonetheless, they need to contain information about any and crucially all adverse events which are associated with the product. This should be accompanied by a scientific assessment of the risk-benefit balance for the same medicine.

PSURS need to be electronically submitted by the EU Qualified Person for Pharmacovigilance (QPPV) appointed to oversee all drug safety work for the project.

The work required to submit a compliant PSUR is commonly outsourced to specialist pharmacovigilance services companies. This is partly underpinned by the principle in practice that non-compliance requires far more resources in the medium to longer term. The format in which they must be submitted is understandably precise, since the same pharmacovigilance laws are in force right across the EU. As well as the format, there is also the question of whether suitable personnel are available to handle adverse event reporting and the risk-benefit analysis.

PSURs have to be submitted at regular intervals. Under ordinary circumstances, these will be closer together at the beginning of the product life, becoming progressively further apart as time goes on. There are occasions on which an application to vary the timing of a submissions can be made. However, it is entirely at the regulators discretion whether to allow any such variation. If PSURs are not correctly submitted on time, there are serious consequences. Again, the resources required following such an incident are typically much greater than if the PSUR had been submitted on time.

If any aspect of a PSUR is not acceptable to the regulators, one of a number of steps will be taken. The steps depend on the nature of the transgression from the accepted format. It could be that the company will be offered some training to help them comply. There are a range of actions that follow, including inspections, formal warnings, and urgent changes to the Marketing Authorisation or suspension from sale.