Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices

摘要

Aim To present the activities of the Agency for MedicinalProducts and Medical Devices in the first 5 years of its existenceand to define its future challenges.Methods Main activities within the scope of the Agencyas a regulatory authority were retrospectively analyzed forthe period from 2004-2008. Data were collected from theAgency’s database and analyzed by descriptive statistics.Results The number of issued medicine authorizationsrose from 240 in 2004 to 580 in 2008. The greatest numberof new chemical and biological entities was approvedin 2005. The greatest number of regular quality controls(n = 5833) and special quality controls was performed in2008 (n = 589), while the greatest number of off-shelf qualitycontrols (n = 132) was performed in 2007. The greatestnumber of medicine labeling irregularities was foundin 2007 (n = 19) and of quality irregularities in 2004 (n = 9).The greatest number of adverse reactions was reported in2008 (n = 1393). The number of registered medical devicesrose from 213 in 2004 to 565 in 2008.Conclusion Over its 5 years of existence, the Agency hassuccessfully coped with the constant increase in workload.In the future, as Croatia enters the European Union, theAgency will have to face the challenge of joining the integratedEuropean regulatory framework.