European Commission launches a public consultation on Paediatric Regulation

The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007. Its objective is to improve the health of children in Europe by facilitating the development and availability of age-appropriate medicines for children, and by increasing available information on the use of medicines for children.


The European Commission launched a public consultation in 2016 on the Paediatric Regulation to review the past ten years of implementation. The consultation closed on 20 February 2017 with feedback received forming an integral part of the Commission's final report assessing the impact of the Paediatric Regulation on public health and the pharmaceutical industry. This report is expected to be published in October 2017.


TOPRA is working with the European Commission to hold a meeting during November 2017 where the outcome of the report can be presented and the views of the many stakeholders can be heard. Further details to follow.

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