2014
DOI: 10.1024/1422-4917/a000322
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Pediatric Psychopharmacological Research in the Post EU Regulation 1901/2006 Era

Abstract: Abstract. Although the use of psychotropic medications in child and adolescent psychiatry in Germany is on the increase, most compounds are in fact prescribed "off-label" because of a lack of regulatory approval in these age groups. In 2007, the European Parliament introduced Regulation 1901/2006 concerning medicinal products in pediatric populations, with a subsequent amendment in the form of Regulation 1902Regulation /2006. The main aim of this legislation was to encourage research and clinical trials in ch… Show more

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Cited by 8 publications
(7 citation statements)
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References 9 publications
(11 reference statements)
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“…To foster collaboration within and outside the EU, the EMA has also created "Paediatric Research Networks" (Enpr-EMA), involving the regulators, academia, the pharmaceutical industry, and patient associations (see below). Nonetheless, the fact that only one PUMA has been granted since 2008 indicates that this regulatory context may still not provide adequate incentives to the industry for the clinical development of offpatent drugs (Schmäl et al, 2014).…”
Section: The Regulatory Context Of Paediatric Psychopharmacology In Ementioning
confidence: 99%
“…To foster collaboration within and outside the EU, the EMA has also created "Paediatric Research Networks" (Enpr-EMA), involving the regulators, academia, the pharmaceutical industry, and patient associations (see below). Nonetheless, the fact that only one PUMA has been granted since 2008 indicates that this regulatory context may still not provide adequate incentives to the industry for the clinical development of offpatent drugs (Schmäl et al, 2014).…”
Section: The Regulatory Context Of Paediatric Psychopharmacology In Ementioning
confidence: 99%
“…Seit den 1990er-Jahren wurden in den USA und Europa regulatorische Maßnahmen ergriff en, um die klinische Forschung und Entwicklung von Medikamenten für Kinder und Jugendliche (qualitativ hochwertig, ethisch) zu fördern, die Zahl der Zulassungen zu steigern, Off -Label-Verschreibungen zu verringern und damit die Qualität der medikamentösen Therapie zu verbessern. (Kölch & Plener, 2016;Persico et al, 2015;Schmäl et al, 2014;Vitiello & Davico, 2018).…”
Section: Forschungssituation In Der Kppkjunclassified
“…In Deutschland ist darüber hinaus zu beobachten, dass sich bei inter-/nationalen klinischen Entwicklungsprozessen nur eine begrenzte Anzahl von Zentren zu Studienteilnahmen bereitfi ndet (Schmäl et al, 2014…”
Section: Forschungssituation In Der Kppkjunclassified
“…Despite the existence of a range of nonpharmacological interventions and highly effective psychopharmacological treatment options, the quality of routine health care for children and adolescents with psychiatric disorders is characterized by various unmet needs and concerns [2,3]. Treatment research has focused primarily on acute treatment, yet many disorders, such as ADHD or early-onset depression, are frequently chronic or recurrent.…”
Section: Unmet Needs In Clinical Practice ▼mentioning
confidence: 99%