The Paediatric Regulation’s main aim is to improve the health of children in Europe without subjecting children to unnecessary trials, or delaying the authorisation of medicinal products for use in adults. The Regulation came into force on 26 January 2007.
All new medicinal products not authorised in the EU before need a Paediatric Investigation Plan (PIP) or waiver / deferral.
In some cases, studies can be deferred until after the studies in adults have been conducted. As some diseases do not affect children (for example Parkinson’s disease), the development of medicines for these diseases should not be performed in children. In these cases, a PIP is not required and it will be waived.
A paediatric-use marketing authorisation (PUMA) may be requested for a medicine which is already authorised, but no longer covered by intellectual property rights and which will be exclusively developed for use in children and benefits from 10 years of market protection as a reward for the development in children.