EU Action Plan Paediatrics Medicines Development


On 2 October 2018, the European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) published a joint action plan to support the development of medicines for children in Europe. This follows the stakeholder workshop that Gilles Vassal and Pamela Kearns took part in on 20 March 2018 at the EMA in London, representing a concrete development following the European Commission report on the Paediatric Regulation.

From the paediatric cancer perspective, the following can be highlighted:

  • Call for multi-stakeholder meetings following theACCELERATE Platform and its Paediatric Strategy Forum model
  • Action to “establish framework for collaboration of EMA/PDCO with the U.S. FDA's Oncology Center of Excellence Pediatric Oncology Program regarding the assessment of relevant molecular targets in paediatric cancers. To maximise synergies and share expertise in the assessment of relevant molecular targets and to address medical needs with a global perspective."

Although there is a long road ahead, the action plan and the ongoing evaluation of the EU Orphan Regulation to supplement the Paediatric Regulation report of the European Commission provide ground for further multi-stakeholder dialogue and cooperation to accelerate the development of innovative medicines for children with cancer.