Table 2.

US and EU pediatric legislation.

US [Rose, 2008, 2014a, 2014b] Introduced 1997 as FDAMA, voluntary Later complemented by mandatory PREA Both reauthorized 2012 as FDASIA Orphan designations are exempt PREA only for same indication as in adults FDA PSPs mandatory after EoP2 meeting Does not threaten to stop adult registration Pediatric and adult registration by respective FDA division

EU [Rose 2008, 2014a, 2014b] In force since 2007 Strong emphasis on mandatory PIP Refused PIP will block adult registration PIP is an almost 1 year complex procedure Detailed PIP to be submitted end of phase I PDCO represents all EU member states PIP handling by PDCO, not EMA specialists Decision about registration later by other EMA committee: CHMP

CHMP, Committee on Human Medicinal Products; FDAMA, US Food and Drug Administration Modernization Act; FDASIA, US Food and Drug Administration Safety and Innovation Act; PDCO, pediatric committee; PREA, Pediatric Research Equity Act; PIP, European Union pediatric investigation plan; PSP, US Food and Drug Administration pediatric study plan.