Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use

The European Medicines Agency (EMEA), in March 2008, proposed a number of measures to improve the assessment of benefit and risks of medicines. The proposals, drawn up by a working group of the Agency’s Committee for Medicinal Products for Human Use (CHMP), are designed to increase consistency, transparency and communication of the CHMP’s benefit-risk assessment. They also include a number of recommendations for further research into risk-benefit assessment methodologies.