The Pediatric Committee ("PDCO") of the European Medicines Agency ("EMA") is tasked with identifying the needs for children in a variety of therapeutic areas and aims to encourage the research and development of pediatric medicinal products. The first Inventory, which is now open for discussion and public consultation, covers medicines for cardiovascular diseases. The EMA points out that it will be releasing similar lists for other therapeutic areas for public consultation during 2012 and 2013.
According to the EMA, the Inventory aims to enable:
- Companies to identify opportunities for business development;
- The PDCO to judge the need for medicines and studies when assessing draft pediatric investigation plans, waivers and deferrals; and
- Healthcare professionals and patients to have an information source available to support their decisions as to which medicines.
The Inventory is based on a report on the survey of all pediatric uses of medicinal products in Europe completed by the PDCO in December 2010.