ABSTRACT
The Pediatric Regulation sets up a framework governing mandatory requirements and incentives for industry in the development of new medicinal products as well as a series of accompanying measures to facilitate approaches to gain access to and improve the exchange of relevant information on medicinal products in pediatric use. The Council of Health Ministers adopted a resolution addressed to the European Commission in 2000 raising the desire for a legislative proposal on the topic of pediatric medicines with high public health priority. After an extended impact assessment of such prospective legislation, outlining started with a first draft proposal in 2004. A company that has the intention to develop a new drug product, or plans new pharmaceutical forms/routes or new indications for an approved medicinal product still under patent protection, will have to consider whether this product can fulfil a pediatric need, including all subsets/age ranges up to 18 years.
