On March 20, 2018 the European Medicines Agency (EMA) and the European Commission organized a workshop to further improve the implemetation of the Paediatric Regulation. The workshop follows the publication of the Commission’s ten-year report on implementation of the Paediatric Regulation and the state of paediatric medicines in the European Union.
The aim of the workhop was to discuss potential improvements of the implementation of the Regulation. It explored opportunities regarding paediatric needs, timely completion of paediatric investigation plans (PIP), and processes and expectations for handling PIP applications.
The main objectives that came of the workshop are as follows:
• To learn from experiences and ideas regarding criteria and methodologies that could be used to
identify diseases/conditions of unmet paediatric medical needs
• To exchange ideas on measures to proactively address obstacles to timely completion of paediatric
investigation plans (PIPs)
• To identify operational challenges in relation to paediatric procedures and exchange ideas for
• To inform stakeholders about ongoing and future initiatives of international collaboration of
regulators for paediatric medicine development
• To inform stakeholders about planned transparency measures regarding clinical research and new
medicines for children
This workshop is a crucial step for the development of a concrete action plan to address challenges identified with medicine development for children in Europe.