News and Educations

HALMED ranked as one of the best agencies in the EU regulatory network


Within the programme of Benchmarking of European Medicines Agencies (BEMA) in the EEA, the Agency for Medicinal Products and Medical Devices (HALMED) received the highest mark excellent (5) among all the benchmarked medicines agencies and many indicators of HALMED’s operations are marked as the best practice at the EU level. These outstanding results rank HALMED among the top agencies within the EU regulatory network. In accordance with the highest marks of certain indicators, HALMED was marked with an exceptional total mark - 4.14 out of the maximal 5.0.

The programme Benchmarking of European Medicines Agencies (BEMA) is carried out by the Heads of Medicines Agencies (HMA). During their stay from 21 to 24 October 2014, BEMA’s assessors thoroughly checked HALMED’s business operations and documentation in order to carry out the final evaluation of HALMED’s operations. HALMED’s highest marks were in business aspects relating to education of stakeholders and promotion of reporting in the area of safety, quality and efficacy, HALMED’s quality system, continuous procedure improvement, conflict of interest management, deadline tracking system and pharmacovigilance system monitoring.

The aim of this system is to assess the current Agency’s ranking, identify the best practices in certain European agencies and provide recommendations for further improvement of procedures. The BEMA has carried out three cycles and HALMED participated for the first time.