Over the last 20 years the focus of post-approval management of medicines has changed from risk management to the assessment and management of benefit-risk. In the EU this has been reinforced by changes in the legislation underpinning pharmacovigilance and the introduction of Good Pharmacovigilance Practice (GVP) modules. The documents used by companies to present and manage the benefits and risks of a product to regulators changed in 2012, requiring a change in focus for companies and regulators which needs to be reflected in increased cross-functional working and continued benefit-risk assessments.