Status of new medicines approved by the European Medicines Evaluation Agency regarding paediatric use

Br J Clin Pharmacol. 1999 Jul;48(1):15-8. doi: 10.1046/j.1365-2125.1999.00981.x.


Aims: To evaluate the activity of the European Medicines Evaluation Agency with regard to the registration for paediatric use of new medicines granted a marketing authorization.

Methods: European Public Assessment Reports published on the Internet from January 95 until April 98 have been analysed using the browser Microsoft Explorer and the software Adobe Acrobat Reader.

Results: Of the 45 new substances licensed since January 95, 29 (64%) were of possible use in children but only 10 were licensed for paediatric use. For the 19 drugs of possible use in children, but not approved for such a use, in nine instances (47%) their summary of product characteristics reported that their use in children has not been established.

Conclusions: A change of practice by pharmaceutical companies and regulatory authorities is imperative so that children are not precluded from having the same rights to medicines as adults.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child
  • Child, Preschool
  • Drug Approval / legislation & jurisprudence*
  • Drug Approval / organization & administration
  • Drug Industry
  • Drug Utilization
  • Europe
  • Humans
  • Pediatrics