New Paper on Advancing Paediatric Oncology Drug Development in the EU and US Published in Frontiers in Medicine
TEDDY is proud to announce that Giorgio Reggiardo, Alessandra Natale, Nicola Santoro, Viviana Giannuzzi, Claudia Pansieri , Mariagrazia Felisi, Donato Bonifazi , and Adriana Ceci, had their work titled “Scientific and Regulatory Progress in Advancing Paediatric Oncology Drug Development in the EU and the US” published in Frontiers in Medicine, in the section Regulatory Science.
This paper provides a comprehensive overview of advancements in paediatric oncology, focusing on key legislative and regulatory changes that have shaped drug development in both the EU and the US. It examines landmark initiatives such as the Research to Accelerate Cures and Equity for Children (RACE) Act (2017) in the US and the revised Paediatric Investigation Plans (PIPs) system in the EU. The study highlights the increasing number of paediatric oncology drug approvals, with a clear trend toward innovative treatments, including targeted therapies and immunotherapies.
Comparing data from 2007–2017 to 2018–2024, the research demonstrates a marked increase in drug approvals and PIPs in both regions, with the US showing a faster pace of approval. However, the authors note that Europe faces persistent gaps, particularly with the proposed abolition of the Paediatric Regulation as part of the EU Pharmaceutical Legislation reform.
This work calls for continued investment and collaboration to address the unmet needs in paediatric oncology treatment, particularly in the European regulatory framework.
You can read the paper HERE.