EMA Seeks to Identify R&D Gaps in Pediatrics

The European Medicines Agency (EMA) has launched a public consultation concerning its inventory of pediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

The inventory is being developed by EMA’s Pediatric Committee (PDCO) and is based on a survey of all the pediatric uses of medicinal products in Europe, which was completed by PDCO in December 2010. By identifying the needs in different therapeutic areas, PDCO hopes that the inventory will help pharmaceutical companies to identify opportunities for new business development. In addition, the lists will enable PDCO to assess the need for medicines and studies when reviewing draft pediatric investigation plans, waivers, and deferrals. In Europe, all applications for marketing authorizations submitted to EMA must include either a product-specific waiver or pediatric investigation plan.

Healthcare professionals and patients will also be able to make use of the inventory to support their decisions in the choice of medication.

The first list to be released includes all cardiovascular medicines for use in children and is open for consultation until Oct. 30, 2012. Details on how to participate are available on the EMA website. Lists for other therapeutic areas will be released for public consultation during 2012 and 2013.

Related articles

Regulatory Intervention in Pediatric Medicines