BEMA - Benchmarking of European Medicines Agencies

The Heads of the European Medicines Agencies (HMAs) within the European Economic Area (EEA) decided during 2003 to commence a benchmarking exercise, formally starting in May 2005 and would continue into foreseeable future. It was named Benchmarking of European Medicines Agencies (BEMA) and is based on the principles of quality and performance management. A steering group, set up by the Heads, coordinates the project with the implementation overseen by the Quality Department of the European Medicines Agency (EMEA) in London. The aim of the benchmarking is to contribute to the development of a world-class pharmaceutical regulatory system, based on a network of agencies, operating to best practice standards.

Each agency performs a self-assessment, in line with a set of questions, focusing on organisation and management, along with functions specific to pharmaceutical agencies among governmental bodies, e.g. marketing authorisations of medicinal products, inspections, pharmacovigilance and clinical trials. The internal self-assessments are then followed up by external peer-reviews and the first round was finalised in May 2006. The internal BEMA self-assessment at the Icelandic Medicines Control Agency was conducted in the fall of 2004. A peer-review team then visited Iceland in November 2005. The results from the visits are collected in a database, forming a basis for further internal work by the agencies and for streamlining the approach by the peer-review teams during their visits