Monday, January 8, 2018

European Parliament Alerts from the Environment, Public Health and Food Safety committee

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Highlights - State of paediatric medicines in the EU - 10 years of the EU Paediatric Regulation - Committee on the Environment, Public Health and Food Safety

08-01-2018 04:14 PM CET

Little girl playing doctor with a teddy bear
On 11 January, the ENVI committee will hold an exchange of views with the Commission on the report it adopted providing the Paediatric Regulation's achievements both in public health and economic terms. The Paediatric Regulation came into force on 26 January 2007. Its objective was to improve the health of children in Europe by facilitating the development and availability of medicines for children.

Figures show that the Regulation has had a positive impact on the development of paediatric medicines, on the authorisation of new medicines, on the use of rewards. However those positive results do not evenly spread among all therapeutic areas. They do concentrate in certain areas, often linked to research priorities in adults rather than children. This shows that the Regulation works best in areas where the needs of adult and paediatric patients overlap. Additional effort is needed to combine the effect of the Regulation with those of the Orphan medicines regulation to address shortcomings in treating rare diseases in children. The Commission now intends to take a closer look at the combined effects of the Orphan and Paediatric Regulation, through a joined evaluation of those two legal instruments in order to providing results by 2019.

Source : © European Union, 2018 - EP


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