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European regulatory framework on the use and development of pharmaceuticals and radiopharmaceuticals for pediatrics

  • A survey in 2000 revealed that only about 30% of the prescriptions in the European pediatric population were on the basis of evidence-based medicine (EbM). Less for radiopharmaceuticals and principally for diagnostics, radiologists throughout Europe are referred to the pediatric guidelines of the European Association of Nuclear Medicine (EANM), as none of the frequently used tracers have beenA survey in 2000 revealed that only about 30% of the prescriptions in the European pediatric population were on the basis of evidence-based medicine (EbM). Less for radiopharmaceuticals and principally for diagnostics, radiologists throughout Europe are referred to the pediatric guidelines of the European Association of Nuclear Medicine (EANM), as none of the frequently used tracers have been evaluated in clinical trials in the different pediatric subgroups. Following a resolution to address the lack of EbM in children, the European Commission published the Pediatric Regulation EC 1901/2006 and its amendment EC 1902/2006, effective from 2007. This regulation foresees the development of evidence-based medicine in the pediatric population. This is effected through a set of principles like the mandatory pediatric investigation plan (PIP) to be included with the market authorization application (MAA), and the pediatric use market authorization (PUMA) for off-patent pharmaceuticals, and to a very small part radiopharmaceuticals with funding possibilities for pediatric-specific research through the 7th Framework Programme (7FP) of the European Union.show moreshow less

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Metadaten
Document Type:Article (reviewed)
Zitierlink: https://opus.hs-offenburg.de/3532
Bibliografische Angaben
Title (English):European regulatory framework on the use and development of pharmaceuticals and radiopharmaceuticals for pediatrics
Author:Marguérite M. Mensonides-Harsema, Andreas OtteStaff MemberORCiDGND
Year of Publication:2011
First Page:43
Last Page:48
Parent Title (English):Hellenic Journal of Nuclear Medicine
Volume:14
Issue:1
ISSN:1790-5427
URL:https://www.nuclmed.gr/wp/wp-content/uploads/2017/03/14-1.pdf
Language:English
Inhaltliche Informationen
Institutes:Fakultät Elektrotechnik und Informationstechnik (E+I) (bis 03/2019)
Institutes:Bibliografie
GND Keyword:Europa; Kinderheilkunde; Pharmazie; Rahmen
Formale Angaben
Open Access: Open Access 
Licence (German):License LogoUrheberrechtlich geschützt