title: Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 years.
abstract: OBJECTIVE
  The 1995-2005 balance of EMEA activities in the field of paediatric medicines was evaluated, taking into account the number both of drugs authorised for children and paediatric studies supporting the Marketing Authorisation (MA).
  
  
  METHODS
  Data on drugs authorised by EMEA were extracted from EPARs (European Public Assessment Reports). Active substance, year of approval, anatomical, therapeutic and chemical (ATC) code, indication, orphan status, ages, and registrative clinical studies characteristics were assessed.
  
  
  RESULTS
  The percentage of authorised substances for paediatrics is 33.3%. This percentage decreased or increased when different subsets of medicines were considered [medicines for children under 2 years (23.4%), N-ATC code drugs (6%) and orphan drugs (46.4%)]. A total of 165 trials were included in the MA dossiers of 51 drugs at the time of approval, and additional 22 studies were added to the dossiers of 12 active substances submitted for paediatric variations. PK and Efficacy/Safety studies were performed for 32 (52%) active substances, while either one PK or one Efficacy/Safety study was carried out for 43 (69%) and 45 (73%) substances, respectively.
  
  
  CONCLUSIONS
  This report demonstrates that the total number of paediatric medicines approved by EMEA is stable over the 10-year period, while an increase in drugs to treat serious or orphan diseases has been observed. In addition, under the Centralised Procedure, a valuable number of paediatric trials have been submitted to support drug approval.
authors.affiliation: Consorzio per Valutazioni Biologiche e Farmacologiche, Via Palestro 26, 27100, Pavia, Italy. aceci@cvbf.net
authors.forename: A
authors.initials: A
authors.lastname: Ceci
authors.forename: M
authors.initials: M
authors.lastname: Felisi
authors.forename: P
authors.initials: P
authors.lastname: Baiardi
authors.forename: F
authors.initials: F
authors.lastname: Bonifazi
authors.forename: M
authors.initials: M
authors.lastname: Catapano
authors.forename: C
authors.initials: C
authors.lastname: Giaquinto
authors.forename: A
authors.initials: A
authors.lastname: Nicolosi
authors.forename: M
authors.initials: M
authors.lastname: Sturkenboom
authors.forename: A
authors.initials: A
authors.lastname: Neubert
authors.forename: I
authors.initials: I
authors.lastname: Wong
mesh_terms: D000293:Adolescent; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D017723:Drug Utilization Review / Q000639:trends*; D005060:Europe; D006077:Government Agencies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008004:Licensure; D009965:Orphan Drug Production / Q000331:legislation & jurisprudence; D010372:Pediatrics; D017891:Pharmacoepidemiology / Q000639:trends