EMA revision of class waivers expected to stimulate development of pediatric medicines

The European Medicines Agency’s Pediatric Committee (PDCO) 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 aim to better balance the need to support development of medicines in children with the goal of avoiding exposing children to unnecessary studies. The revisions will, hopefully, encourage companies to develop more new medicines for use in children, the EMA stated.

The revisions follow the PDCO’s review of the experience with class waivers since the Pediatric Regulation came into force in 2007. In its review, it noted that most of the class waivers refer only to medicines targeting specific diseases. This could mean that 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.