Significant date ahead for EU Paediatric Regulation

The Medicines for Children Research Network has produced a handy summary of developments regarding the the EU Paediatric Regulation. In short, while over 100 million people in the EU -- around 22% of its population -- are under 19 years old, more than half the medicines they take have not been tested or authorised specifically for their use. The dangers are obvious and need not be spelled out here. In 2006 the EU Paediatric Regulation was adopted. This provided for the establishment of the Paediatric Committee (PDCO), allowing drug manufacturers to apply for Paediatric Investigation Plans (PIPs) or requests for waivers.

This is very topical since tomorrow, 26 July 2008, is the date from which there is imposed an obligation to submit results of studies according to an agreed PIP with applications for (new) marketing authorisations (see Article 7) or a decision granting a waiver or deferral.

The new requirements apply to most products, but not to generics, hybrid applications, biosimilars and well-established medicinal products, or to homeopathic and traditional herbal medicinal products. Different rules govern patented and off-patented medicines, as well as both rewards and incentives for compliance.

For products still under patent, a PIP must be submitted and agreed with the PDCO. If the agreed programme is conducted and the obligations are fulfilled there is the possibility of gaining a 6 months extension of the Supplementary Patent Certificate.