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Published on: December 4, 2016
Paediatric Regulation in the European Union: an overview
Paolo Caferra1, Thomas Fraisse2, Veronica Baffa3
1Department of Pharmacy, University of Pisa, Via Bonanno, 6, 56126 Pisa, Italy; Research and Development, Sanofi, Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands.
None:
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.
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