European Medicines Agency benefit-risk methodology project: Description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network. Summary of the original report

A summary report on the first work package of the European Medicines Agency's Benefit-Risk Methodology Project – a project aiming to increase the consistency and transparency of the regulatory process through standardised practices for assessing the benefit-risk balance of medicines – was published at the end of March 2010.