A paediatric investigation plan (PIP) is a medicines development plan to support the authorisation of a medicine for children. It aims to ensure that the necessary data is obtained through studies in children, when it is safe to do so.
Pharmaceutical companies submit proposals for PIPs to the European Medicine Agency’s (EMA) Paediatric Committee (PDCO). This Committee is responsible for agreeing to or refusing the plan.
The normal development of a medicine requires that various studies be performed to ensure its quality, safety, and efficacy. In addition to this, PIPs:
- include a description of the studies and of the measures to adapt the medicine’s formulation to make its use more acceptable in children, such as the use of a liquid formulation rather than large tablets;
- cover the needs of all age groups of children, from birth to adolescence;
- define the timing of studies in children compared to adults.
In some cases, studies can be deferred until after the studies in adults have been conducted. This ensures that research in children is only done when it is safe and ethical to do so.
As some diseases do not affect children (for example, Parkinson’s disease), the development of medicines for these diseases should not be performed in children. In these cases, a PIP is not required and can be waived.