EMA Aims to Give New Impetus to Pediatric Trials
The Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has revised the current list of class waivers for medicines that are not required to submit a pediatric investigation plan.
The Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has revised the current list of class waivers for medicines that are not required to submit a pediatric investigation plan (PIP).
These are the most extensive revisions to date, and are designed to better balance the need to support development of medicines in children with the goal of avoiding exposing children to unnecessary studies, according to a statement from EMA. It hopes the revisions will encourage companies to develop more new medicines for use in children.
The revisions follow the PDCO’s review of the experience with class waivers since the Pediatric Regulation came into force in 2007. It noted that most of the class waivers refer only to medicines targeting specific diseases, and this may mean the potential for the use of the medicines in children more generally is not explored. The 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.
As a result, the 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. It has revoked eight class waivers, updated 15 class waivers and confirmed nine class waivers in the current class waiver 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 the PDCO.
In future, more medicines will be reviewed by the PDCO for potential development for use in children, and the PDCO will continue to revise the class waiver list as more information becomes available, according to the EMA.
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