The EU Paediatric Regulation: Operational & Strategic Considerations (Industry Perspective)

New legislation, Regulation (EC) No 1901/2006^{1, 2} (the Paediatric Regulation), governing the development and regulatory approval of medicines in children became effective in Europe in January 2007. The Paediatric Regulation imposes significant obligations on the pharmaceutical industry to address the potential need for paediatric development as a prerequisite for approval in the adult population. In return, companies are offered incentives for addressing the challenge of pharmaceutical development in the paediatric population. The regulation applies to all medicinal products for human use except generic products, biosimilar products, products authorised by well-established use, and homeopathic and traditional herbal medicines. While the regulation entered into force in January 2007, transitional provisions apply, i.e., the paediatric obligation applies to new medicines not previously approved in the EU from 26 July 2008, and to line extensions of authorised on-patent medicines from 26 January 2009.