Original scientific paper
Regulating Medicines in Croatia: Five-year Experience of Agency for Medicinal Products and Medical Devices
Siniša Tomić
; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Anita Filipović Sučić
; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Ana Plazonić
; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Rajka Truban Žulj
; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Viola Macolić Šarinić
; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Branka Čudina
; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Adrijana Ilić Martinac
; Agency for Medicinal Products and Medical Devices, Zagreb, Croatia
Abstract
Aim To present the activities of the Agency for Medicinal
Products and Medical Devices in the first 5 years of its existence
and to define its future challenges.
Methods Main activities within the scope of the Agency
as a regulatory authority were retrospectively analyzed for
the period from 2004-2008. Data were collected from the
Agency’s database and analyzed by descriptive statistics.
Results The number of issued medicine authorizations
rose from 240 in 2004 to 580 in 2008. The greatest number
of new chemical and biological entities was approved
in 2005. The greatest number of regular quality controls
(n = 5833) and special quality controls was performed in
2008 (n = 589), while the greatest number of off-shelf quality
controls (n = 132) was performed in 2007. The greatest
number of medicine labeling irregularities was found
in 2007 (n = 19) and of quality irregularities in 2004 (n = 9).
The greatest number of adverse reactions was reported in
2008 (n = 1393). The number of registered medical devices
rose from 213 in 2004 to 565 in 2008.
Conclusion Over its 5 years of existence, the Agency has
successfully coped with the constant increase in workload.
In the future, as Croatia enters the European Union, the
Agency will have to face the challenge of joining the integrated
European regulatory framework.
Keywords
medicinal product; marketing authorization; variations; quality control; quality defect; pharmacovigilance; international co-operation; medical devices
Hrčak ID:
53512
URI
Publication date:
15.4.2010.
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