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, 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 fifth cycle of visits which will begin in 2022 and end in 2024.

Under BEMA IV, the HPRA was assessed by BEMA assessors in October 2017. 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.