Strengthening international cooperation
Developing new oncology drugs for children and adolescents is a global endeavour because cancer is a rare disease and still the first cause of death disease in high income countries. Regulatory initiatives have been launched over the past 20 years in the US, in Europe and in Canada to improve the evaluation of safe and effective medicines for children. While several paediatric specialities have benefited from those regulations with more medicines evaluated and approved for the treatment of children, paediatric oncology has benefited less in the face of the field of oncology drug development in adults dramatically advancing, due to better knowledge of the biology of cancer.
There is a brand new regulatory environment with the implement of the revised calls waiver list by EMA as of July 2018 and the 2017 FDARA RACE for Children Act as of August 2020.
The working group will:
- identify current hurdles and limitations in international collaboration for the development of new anticancer drugs for children and adolescents
- make strategic proposals to accelerate global development within a new and harmonized regulatory environment.