EMA Revises Class Waiver List to Support Pediatric Drug Development

July 23, 2015

This move is expected to stimulate the exploration of many more medicines for use in children.

The European Medicines Agency’s Pediatric Committee (PDCO) announced that it has extensively revised the current list of class waivers for medicines that are not required to submit a pediatric investigation plan (PIP). This move will better support the development of pediatric drugs without exposing children to unnecessary studies. It is hoped that companies will be encouraged to develop more new medicines for use in children.

The revisions follow PDCO’s review of the experience with class waivers since the Pediatric Regulation came into force in 2007. PDCO noted that most of the class waivers refer only to medicines targeting specific diseases, which could mean that the potential for the use of the medicines in children more generally is not explored. PDCO concluded that the current class waiver list resulted in insufficient opportunities for the Committee to consider the potential benefits of some new medicines for children.

PDCO has assessed, for all class waivers, the available information on the disease area, the characteristics of the medicines, and any available evidence on their possible use in children. Eight class waivers were revoked, 15 class waivers were updated, and nine class waivers were confirmed in the current list.

Companies developing medicines, which are not covered by the revised list of class waivers, will need to submit a request for a PIP or a product-specific waiver, for scientific review and agreement by PDCO.

PDCO will continue to revise the class waiver list as more information on medicines and diseases becomes available.

Source: EMA