In 2004, the Heads of European Medicines Agencies established a benchmarking programme ‘to contribute to the development of a world-class pharmaceutical regulatory system, based on a network of agencies, operating to best practice standards.’ The benchmarking of European Medicines Agencies (BEMA) is based on a self-assessment by each EU medicines agency against a set of indicators covering management systems and technical work in the areas of assessment of marketing authorisation applications, pharmacovigilance (drug safety), and inspections. The exercise is not designed for direct comparison or ranking of agencies. Following the self-assessment, assessors from other Member States conduct an independent assessment of the agency and compile a report with their findings on the self-assessment, identified strengths/best practices of the agency and areas for further improvement. Reports from all the visited agencies are entered into a database which forms a valuable resource for best practice across the entire EU network of medicines agencies. The benchmarking programme is entering its fourth cycle of visits which will begin in 2016 and end in 2018.
Under BEMA III, the HPRA (then the IMB) was assessed by BEMA assessors during the week of 14 October 2013. We appreciated the external review of our systems and processes, the recognition of a number of best practices by the assessors, and the opportunities for improvement noted by them which has supported our continual improvement programme.
The head of the HPRA, Mr Pat O’Mahony, was a co-chair of the BEMA Steering Group between 2008 and 2015, and the HPRA provided the secretariat for the group during that time.