Boosting the development of medicines for children

EMA

2 October 2018 - The EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published today a joint action plan to support the development of medicines for children in Europe.

The action plan addresses challenges identified by the European Commission’s ten-year report on the implementation of the Paediatric Legislation. It also takes into account the ideas on how to better apply the Paediatric Regulation to boost the development of medicines for children collected during the multi-stakeholder workshop organised by EMA and the European Commission in March 2018.

The actions in the plan are clustered around five key areas:

  • identifying paediatric medical needs
  • strengthening cooperation between decision makers
  • ensuring timely completion of paediatric investigation plans (PIPs)
  • improving the handling of PIP applications
  • increasing transparency around paediatric medicines

Read EMA press release

Michael Wonder

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Michael Wonder