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