Module232025

07/05/2025

Before the EU Paediatric Regulation came into effect in 2007, many medicines authorised in Europe were not studied adequately or authorised in children. This caused difficulties for prescribers and pharmacists treating children, as well as for their patients and carers. The Regulation introduced sweeping changes into the regulatory environment for paediatric medicines, designed to better protect the health of children in the EU. The main change was the creation and operation of the Paediatric Committee (PDCO) to provide objective scientific opinions on paediatric investigation plans (PIPs), development plans for medicines for use in children.

The Organisation for Professionals in Regulatory Affairs

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The main aim of non-clinical studies to support the development of medicinal products to be used in paediatric patients is to obtain information on the potentially different safety profiles from those seen in adults. Studies using juvenile animals can, in some instances, be used to investigate identified concerns that cannot be adequately, ethically, and safely assessed in paediatric clinical trials.

The Organisation for Professionals in Regulatory Affairs

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