Abstract
On 12 December 2006, the European legislature adopted the Paediatric Regulation after several years of heated debates. The purpose of the new legislation is to generate data on the safety and efficacy of medicinal products when used in children and to promote the development of paediatric medicinal products. The European paediatric regime is based on a stick-carrot philosophy and thus contains two main parts. The first part concerns the paediatric obligation and procedure. Experience had showed that pharmaceutical companies do not voluntarily invest in paediatric research; hence, they had to be forced to conduct paediatric studies. The second part concerns the rewards granted for having fulfilled the paediatric obligation. This contribution examines and discusses the different paediatric rewards and conditions to benefit therefrom, and answers some key questions.
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