Tomić Sinisa, Filipović Sucić Anita, Plazonić Ana, Truban Zulj Rajka, Macolić Sarinić Viola, Cudina Branka, Ilić Martinac Adrijana
Agency for Medicinal Products and Medical Devices, Ksaverska cesta 4, 10000 Zagreb, Croatia.
Croat Med J. 2010 Apr;51(2):104-12. doi: 10.3325/cmj.2010.51.104.
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.
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.
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.
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.
介绍药品和医疗器械局成立头5年的活动，并明确其未来面临的挑战。
对2004年至2008年期间该局作为监管机构范围内的主要活动进行回顾性分析。数据从该局数据库收集，并通过描述性统计进行分析。
发放的药品授权数量从2004年的240份增至2008年的580份。2005年批准的新化学实体和生物实体数量最多。2008年进行的常规质量控制数量最多（n = 5833），特殊质量控制数量最多（n = 589），而2007年进行的下架质量控制数量最多（n = 132）。2007年发现的药品标签违规数量最多（n = 19），2004年发现的质量违规数量最多（n = 9）。2008年报告的不良反应数量最多（n = 1393）。注册医疗器械数量从2004年的213件增至2008年的565件。
在其成立的5年里，该局成功应对了工作量的不断增加。未来，随着克罗地亚加入欧盟，该局将不得不面对加入欧洲综合监管框架的挑战。
