European Medicines Agency starts consultation on inventory of needs for children's medicines
The European Medicines Agency has begun its first public consultation on its inventory of paediatric medicines.
This inventory, which is being developed by the Agency's Paediatric Committee (PDCO), sets out areas where further research and development into medicines for children are needed. It aims to enable:
- companies to identify opportunities for business development;
- the PDCO to judge the need for medicines and studies when assessing draft paediatric investigation plans, waivers and deferrals;
- 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 paediatric uses of medicinal products in Europe completed by the PDCO in December 2010.
The first list, released today, includes all cardiovascular medicines for use in children. The Agency will be releasing similar lists for other therapeutic areas for public consultation during 2012 and 2013.
The list is open for comments until 30 October 2012. Comments should be sent to email@example.com with 'comments on the list of paediatric needs' in the subject line. After the consultation period, the PDCO will review all comments and amend the document as necessary, before publishing the final version of the list along with an overview of the comments received.