The European Medicines Agency (EMA) released the report entitled “How to better apply the Paediatric Regulation to boost development of medicines for children”, related to the multi-stakeholder workshop held at the EMA on 20 March 2018. The workshop was the occasion to discuss and identify ways to improve the implementation of the Paediatric Regulation, that came into force in 2007 and defined the EU’s regulatory framework for paediatric medicines development.
The event has seen the participation of patients and caregivers, academics, healthcare professionals, CROs and pharmaceutical industry representatives, as well as clinical trial assessors from national competent authorities (NCAs), ethics committees, EMA including representatives of Paediatric Committee (PDCO) and the European Commission (EC). The workshop aimed to support the development of a concrete action plan to address shortcomings identified in the 10 years report on the implementation of the Paediatric Regulation published by the EC in 2017. The workshop report, published after the event, provides a high-level summary of the main ideas and proposals discussed during the meeting and a focus on the following five main topics:
– Identifying paediatric medical needs
– International cooperation between regulators
– Timely completion of Paediatric Investigation Plans (PIPs)
– Improving the handling of PIP applications
– Increasing transparency around paediatric medicines
Overall, the multi-stakeholder workshop represented a unique occasion for an open dialogue and exchange of ideas among all stakeholder groups and a crucial step in the development of an EC/EMA action plan.
EMA has also produced a factsheet and a video for insights and views of this regulation.