One of the major initiatives the Regulators in the European Union (EU) have taken to boost the development of medicines for children is to more efficiently facilitate the establishment of Paediatric Investigation Plans (PIPs). As a result, EMA is launching a pilot phase for a stepwise PIP (sPIP) agreement which will open the door for agreement based on a partial paediatric development programme and conditioned by modifications as agreed with the Paediatric Committee (PDCO).

A PIP is a development plan aimed at ensuring that the necessary data are obtained through studies on children, to support the authorization of medicine for children. A PIP must be submitted early in the development, not later than upon completion of the human pharmacokinetic studies in adults and should specify the timing and measures proposed to assess quality, safety, and efficacy of the medcinal product in all subsets of the paediatric population that it may concern.

According to the sPIP pilot guidance, an sPIP submission could be considered when critical elements such as study design, population or main objectives cannot be defined. However, in the presence of existing precedence it is not expected that a sPIP would be warranted in most cases.

The sPIP concept is a leaner regulatory-scientific approach that allows for changes to be made to the plan as more evidence becomes available over time. The pilot project started in February and aims to evaluate eight adopted initial opinions in order to gather experience.

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