It should also be noted that the initiation of a considerable percentage of clinical trials included in a paediatric investigation plan has been deferred in order to avoid delays in the authorisation of the corresponding product for adults. Hence, the impact of the Paediatric Regulation on paediatric trials will become more apparent in EudraCT in the years to come.
De plus, il convient de remarquer que le démarrage d’une partie considérable des essais cliniques s’inscrivant dans un plan d’investigation pédiatrique a été reporté afin d’éviter des retards dans l’autorisation des médicaments correspondants destinés aux adultes.