| Regulating medicines in Croatia: five-year experience of Agency for Medicinal Products and Medical Devices. | |
| | |
MedLine Citation:
|
PMID: 20401952 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
Sinisa Tomić; Anita Filipović Sucić; Ana Plazonić; Rajka Truban Zulj; Viola Macolić Sarinić; Branka Cudina; Adrijana Ilić Martinac |
Publication Detail:
|
Type: Journal Article |
Journal Detail:
|
Title: Croatian medical journal Volume: 51 ISSN: 1332-8166 ISO Abbreviation: Croat. Med. J. Publication Date: 2010 Apr |
Date Detail:
|
Created Date: 2010-04-19 Completed Date: 2010-07-16 Revised Date: 2011-01-04 |
Medline Journal Info:
|
Nlm Unique ID: 9424324 Medline TA: Croat Med J Country: Croatia |
Other Details:
|
Languages: eng Pagination: 104-12 Citation Subset: IM |
Affiliation:
|
Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, 10000 Zagreb, Croatia. sinisa.tomic@almp.hr |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Adverse Drug Reaction Reporting Systems Croatia Device Approval Drug Approval Drug and Narcotic Control* / methods, organization & administration Equipment and Supplies / standards* Humans Quality Control Reference Standards Retrospective Studies |
| Comments/Corrections | |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Croatian Medical Journal citation score in Web of Science, Scopus, and Google Scholar.
Next Document: Rivaroxaban vs dabigatran for thromboprophylaxis after joint-replacement surgery: exploratory indire...