Summary
The European Parliament calls for a review and potential revision of the regulation on paediatric medicines to better address unmet medical needs, particularly in childhood cancer and neonatology. It emphasizes improving incentives and research strategies to reduce off-label drug use in children. 10 15.12.2016
Other
health
research and intellectual property
Key points
- The existing regulatory framework has successfully increased the number of paediatric research projects and clinical trials.
- Significant progress is still needed in critical areas such as childhood cancer and neonatology.
- There is a widespread concern regarding the frequent use of medicines in children that have not been specifically authorised for their age group.
- A very low percentage of approved paediatric investigation plans are actually completed.
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