title: [Improving drug licensing for children and adolescents : Position paper from the More Medicines for Minors Symposion 8 June 2015 in Bonn].
abstract: In Germany and throughout Europe, medicinal products for adults have been developed and evaluated systematically for decades. Medicinal products for children and adolescents, however, have only been researched for the past ten years. As a result, many medicinal products have been administered to children without systematic clinical trials, for example regarding dosage or pharmaceutical form.EU Regulation 1901/2006 aimes to close the gaps in the medical treatment of children and adolescents. In order to do so, the regulation provides for paediatric use marketing authorisations (PUMA) for previously authorised products no longer covered by intellectual property rights and also grants holders of such PUMA licenses further property rights. However, only two PUMA licenses have been applied for. Thus, the PUMA license instrument is hardly being used despite the fact that many medicinal products have a great potential for closing medical gaps for children and adolescents.In order to improve the situation regarding medicinal products for children and adolescents, this scientific symposium "More Medicines for Minors" intended to promote dialogue among the parties involved and to provide an opportunity to discuss reasons for the reluctance to apply for PUMA licenses. Speakers specialised in paediatric and adolescent medicine as well as those from licensing authorities, the Federal Joint Committee (Gemeinsamer Bundesausschuss, G‑BA), the pharmaceutical industry and the federal ministries presented problems and possible solutions from their point of view with the aim of making the PUMA license instrument more attractive.
authors: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger Allee 3, 53175, Bonn, Deutschland. claudia.riedel@bfarm.de.
authors: Claudia
authors: C
authors: Riedel
authors: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger Allee 3, 53175, Bonn, Deutschland.
authors: Birka
authors: B
authors: Lehmann
authors: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger Allee 3, 53175, Bonn, Deutschland.
authors: Karl
authors: K
authors: Broich
authors: Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger Allee 3, 53175, Bonn, Deutschland.
authors: Thomas
authors: T
authors: Sudhop
mesh_terms: D000293:Adolescent; D000067697:Adolescent Health / Q000331:legislation & jurisprudence; D002648:Child; D000067576:Child Health / Q000331:legislation & jurisprudence; D002675:Child, Preschool; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005260:Female; D005858:Germany; D033161:Government Regulation; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007880:Legislation, Drug; D008004:Licensure / Q000331:legislation & jurisprudence*; D008297:Male; D010372:Pediatrics / Q000331:legislation & jurisprudence* / Q000592:standards; D010600:Pharmacology / Q000331:legislation & jurisprudence* / Q000592:standards; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards*
keywords: BfArM; Marketing authorisation for medicinal products; Medicinal products for the paediatric population; Medicines for children; PUMA