European regulators just announced a massive overhaul of pediatric waivers
- As part of a larger effort to increase the number of clinical trials involving children, the European Medicines Agency (EMA) is revoking or modifying most pediatric waivers.
- There are concerns about testing drugs in children, but testing is needed in order to increase the number of drugs approved for treatment of various diseases and disorders in children.
- The baseline rule, established in 2007, is that companies must complete a pediatric investigation plan (PIP) unless they meet the criteria for one of the three main pediatric waivers.
The EMA is not just overhauling the pediatric waiver system. The entire system of waivers is currently in flux as the EMA revokes eight classes of waivers including drugs used to treat several cancers, as well as Parkinson's disease and Hutington's disease. Initially, the rationale for seeking a pediatric waiver was that some diseases don't affect children; however, there are often instances where a child needs a specific drug and there are no data to confirm appropriate dosing or what outcomes to expect. This is where the EMA seeks to fill the gap.
- Regulatory Affairs Professional Society EMA Announces Sweeping Overhaul of Pediatric Class Waivers