Needs for paediatric medicines

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: Full report

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 European Medicines Agency / Paediatric Working Party procedure for identifying paediatric needs .

• New medicines for type 2 diabetes in adolescents: many products, few patients

• Guidance for clinical trials for children and adolescents with chronic hepatitis C