Paediatric Investigation Plan

What is Pediatric Investigation Plan ?

A Pediatric Investigation Plan (PIP) is a formal document requiring coordination and consistent planning of studies on children population throughout Europe for medications such as new or existing approved, orphan or unlicensed drugs. PIPs provide public health agencies with the benefit of accessing multiple data sources on the same medication for improved comparisons across indications, populations and routes of administration.


PIP aims to support comparability of evidence for health technology assessments (HTAs) carried out by Member States (MSs).


The plan should include information about the disease or condition, drug or product, possible risks and benefits, study procedures that are being considered, estimated costs of each procedure to be tested in children, time required for completion of each procedure, estimated number of patients who can be involved in the study, sources of patients at each site and where they will come from, and any data that are presently available.


When should I submit PIP?

PIPs are mandatory for all new or existing approved, orphan or unlicensed drugs being considered in the pediatric population. They must be submitted before starting any pediatric clinical trial. Exceptions are studies in neonates if the indication is so narrow that it clearly excludes this population.


What is Iris EMA?

Iris EMA is a browser-based PIP tool which helps the researchers to prepare the pediatric investigation plan according to CDISC standards


It includes step by step guides and decision trees for each data source.


When should I use Iris EMA?

Iris EMA can be used from idea to final submission of successfully finished pediatric clinical trial.


Iris EMA can be used as an educational tool for writing PIP and also to speed up the process by search criteria such as disease, drug or population.


What is a product specific waiver?

Some requests may require an individual approach. In such cases, the applicant has to provide a compelling argument that a waiver of the requirement is justified for pediatrics studies in children aged <18 years or that it should be allowed for a specific population. If all efforts to obtain appropriate data from non-clinical sources have been unsuccessful and no other means can be found to obtain this data, a product specific waiver may be possible.