Paediatric Regulation in the European Union: an overview.

Paediatric Investigation Plans (PIPs) are a critical component of the EU's regulatory strategy to ensure that medicines are appropriately studied, developed and authorised for use in children. The legislative scheme for PIPs was established under Regulation (EC) no. 1901/2006, also known as 'Paediatric Regulation'. Paediatric Regulation mandates that all new marketing authorisation applications and line extensions must include data from PIPs unless waivers or deferrals have been granted. This literature review's objective is to explore the 'PIPs, waivers and deferrals' regulatory framework for on- and off-patent drugs and provide a glimpse of the new 'pharma package' upcoming changes.