Lack of effect of the European guidance on clinical investigation of medicines in children.
OBJECTIVE
To evaluate the registration for paediatric use of new chemical entities (NCEs) granted a marketing authorization (product licence).


METHODS
European Public Assessment Reports (EPARs) published on the Internet from January 1995 to May 2001 were analysed.


RESULTS
Of 120 new substances licensed since January 1995, 70 (58%) were of potential use in children. Of these, only 17 were licensed for all paediatric uses, and 15 for some paediatric age groups. Hence, the majority (54%) of these substances were probably not tested in paediatric age groups.


CONCLUSIONS
Many of the new drugs granted marketing authorization lack sufficient paediatric labelling. The proportion of drugs for which full labelling was available has not increased in recent years. The European Medicines Evaluation Agency should make an effort to improve this situation.
't Jong
G W
GW
Department of Paediatrics, Sophia Children's Hospital, Erasmus Medical Centre Rotterdam, The Netherlands.
Stricker
B H Ch
BH
Choonar
I
I
van den Anker
J N
JN
D002648:Child; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D005060:Europe; D006801:Humans; D010372:Pediatrics