Regulating medicines in Croatia: five-year experience of Agency for Medicinal Products and Medical Devices.
OBJECTIVE
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.


CONCLUSIONS
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.
Tomić
Sinisa
S
Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, 10000 Zagreb, Croatia. sinisa.tomic@almp.hr
Filipović Sucić
Anita
A
Plazonić
Ana
A
Truban Zulj
Rajka
R
Macolić Sarinić
Viola
V
Cudina
Branka
B
Ilić Martinac
Adrijana
A
D016907:Adverse Drug Reaction Reporting Systems; D017523:Croatia; D018795:Device Approval; D017277:Drug Approval; D004335:Drug and Narcotic Control / Q000379:methods / Q000458:organization & administration; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D011786:Quality Control; D012015:Reference Standards; D012189:Retrospective Studies
Eur J Clin Pharmacol. 1995;47(6):471-6
7768246
Commun Dis Public Health. 2003 Dec;6(4):355-7
15067864
Eur J Epidemiol. 2003;18(4):299-303
12803369
Croat Med J. 2001 Dec;42(6):606-10
11740841
Nat Rev Drug Discov. 2008 Oct;7(10):818-26
18787530
Eur J Cancer. 2006 Mar;42(4):446-55
16129598
Med Device Technol. 2007 Nov-Dec;18(7):34, 36-7
18075133
Thromb Haemost. 2006 Oct;96(4):423-32
17003918
J Gen Intern Med. 2008 Jan;23 Suppl 1:57-63
18095046
J Ambul Care Manage. 2004 Apr-Jun;27(2):98-104
15069986
Onkologie. 2008;31 Suppl 2:64-6
18487872
Med Device Technol. 2008 Sep;19(5):16-8, 20
18947145
Prescrire Int. 2005 Jun;14(77):115-7
15984108
Bull Mem Acad R Med Belg. 2000;155(5-6):254-8; discussion 259-62
11304960
J Tissue Viability. 1999 Jan;9(1):11-5
10480978
Soc Sci Med. 1999 Jun;48(11):1655-67
10400264
Therapie. 2007 Sep-Oct;62(5):427-35
18206104
Med Device Technol. 2006 Jan-Feb;17(1):22-5
16483107
Drug Ther Bull. 2009 Apr;47(4):45-8
19357299
Rev Prat. 2005 Nov 30;55(18):2026-32
16419907
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2008 Jul;51(7):757-63
18563281
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2008 Jul;51(7):731-9
18584106
Stud Health Technol Inform. 1996;28:13-6
10172826
Stud Health Technol Inform. 1996;28:5-12
10172825
Intern Med J. 2008 Jul;38(7):559-67
18336542
Arch Intern Med. 2005 Jun 27;165(12):1363-9
15983284
J Ambul Care Manage. 2004 Apr-Jun;27(2):89-97
15069985
Manag Care Interface. 2005 May;18(5):27-30
15941187
Ann Pharm Fr. 2000 Jul;58(4):278-85
10915977
Eur J Clin Pharmacol. 2010 Jan;66(1):39-48
19936724
Z Arztl Fortbild Qualitatssich. 1997 Nov;91(7):593-6
9527447
Int J Technol Assess Health Care. 2003 Winter;19(1):228-48
12701954