DIA EUROPE 2021

Many stakeholders demand acceleration of paediatric development, specifically in the field of Paediatric Oncology. Global collaboration has been recognized as an important issue in the EC/EMA paediatric action plan adopted in 2018. Harmonization of standards and requirements for paediatric population has been accomplished through ICH. Collaboration between regulators in cluster discussions have been ongoing since 2007 to avoid unnecessary clinical trials in children. Through this long standing close interaction confidence building between regulators has been accomplished and a trusted relationship was established. The ICH expert working group developed several important documents that helped to introduce harmonised approaches for pediatric drug development. The global implementation of innovative approaches such as e.g. extrapolation, historical control arms (RWD) or Bayesian statistics may lead to more focused development of pediatric medicines. Closing the gap between adult marketing authorisation and the availability paediatric medicines is the ultimative goal to address unmet paediatric medical need. WHO has developed draft principles for regulatory reliance in 2020 that are recommended for implementation to improve allocation of scarce resources and achieve smart regulatory systems Reliance is defined as an act where regulators in one jurisdiction take account or give significant weight to assessments performed by regulators in other regions. Europe is discussing changes to its paediatric framework to better address unmet paediatric needs and speed up medicine developments, specifically in Oncology and rare diseases. The paediatric regulatory system is ripe for embracing the regulatory reliance principles to strengthen global cooperation and focus scarce resources. What might be needed to move global collaboration to the next level? Can reliance on paediatric plan assessments be a catalyst to speed up global development of new paediatric medicines?