Insights

Paediatric Investigation Plans (PIPs), introduced by Regulation (EC) No 1901/2006, play a crucial role in the development of medicines intended for use in children. A PIP is a comprehensive plan developed by pharmaceutical companies in collaboration with the European Medicines Agency (EMA) to ensure that data on the use of medicines in children is generated. This is particularly important for treatments initially developed for adult populations, where the safety and efficacy for children must be specifically evaluated due to their unique physiological characteristics.

The requirement for a PIP aims to guarantee that medicines undergoing development include appropriate paediatric studies, ensuring that children have access to safe and effective treatments. The plan includes details on study design, dosing regimens, and the timing of clinical trials.

As part of the ongoing effort to improve the submission and review process, starting from 04 June 2024, the EMA transitioned to the IRIS portal for paediatric-related submissions, including initial PIPs, modifications, product-specific waivers, and more. The IRIS platform significantly enhances the transparency and efficiency of the paediatric application process by enabling real-time tracking, better integration of data, and faster interactions with the EMA.

RPN multidisciplinary team has the expertise to provide PIP strategic guidance, to define a tailored PIP and support companies in interacting with EMA, including the use of the IRIS portal.