Needs for paediatric medicines
HumanRegulatory and procedural guidancePaediatricsResearch and development
The European Medicines Agency is developing an inventory of the needs for paediatric medicines, to help medicinal-product developers identify opportunities.
In addition to its benefits for industry, the inventory aims to enable:
- the Paediatric Committee (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 to choose.
The need for the inventory stems from a report adopted by the PDCO in December 2010, on the survey of all paediatric uses of medicines in Europe:
- Report on the survey of all paediatric uses of medicinal products in Europe: Executive summary
- Report on the survey of all paediatric uses of medicinal products in Europe: Questions and answers
- Report on the survey of all paediatric uses of medicinal products in Europe
The Agency is publishing lists of medicines by therapeutic class one by one in the tables below. Each list is open for comments for two months after publication.
This project builds on an earlier exercise to establish paediatric needs, which the former Paediatric Working Party carried out between 2001 and 2007. The outcome of this exercise is also included in the tables below. This earlier exercise was conducted according to the EMEA/PEG Procedure for identifying paediatric needs.
Off-label use in children
The Agency has also produced a report on the off-label use of medicines in children. This explains that off-label use is associated with more adverse reactions to medicines for children and that adverse reactions in children may be more severe or different from what is known in adults.