The current study is aimed at providing a review of the economic impacts of the Regulation since it entered into force until the end of 2015. This study thus covers the following dimensions: (i) Analysis of the regulatory costs to the pharmaceutical industry for meeting legal obligations; (ii)...

The Paediatric Regulation was enacted in the European Union in 2007 to encourage development of suitable medicine for children, promote high quality research, improve the information available on the use of medicines in children, and to prioritise the therapeutic needs in this group. The current...