Paediatric Investigation Plan

Clinical trials on children are based on a Paediatric Investigation Plan (PIP) that the applicant for a marketing authorisation must prepare well on time in the course of the development efforts.

The investigation plan is to be presented to the Paediatric Committee in the early stage of the development project. Since the development of drugs is a dynamic process affected by the findings of the ongoing research, an approved investigation plan may be amended if necessary.

All the studies completed in accordance with an approved investigation plan for a paediatric medicinal product and the results of such studies must be provided in connection with the application for marketing authorisation unless a waiver or deferral has been granted.

Waivers and deferrals

An applicant for a marketing authorisation may apply for a waiver if diseases or conditions to be treated with the medicine do not occur in the paediatric population or if the medicine is not otherwise suitable for treating children. Nor should children be subjected to unnecessary trials. Similarly, the applicant for a marketing authorisation may request a deferral when it is appropriate to conduct studies in adults or older children prior to initiating studies in the paediatric population.

Communication from the Commission:

Guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies.