European Medicines Agency (EMA)

The European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in London, UK. The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

The main responsibility of EMA is the protection and promotion of public and animal health through the evaluation and supervision of medicines and verterinary use. 

Within EMA, there is a domain specialised in paediatrics, the Paediatric Committee (PDCO) which is responsible for assessing the content of paediatric investigation plans (PIPs) and adopting opinions on them. This includes assessing applications for full or partial waivers and assessing applications for deferrals.

The PDCO was established in accordance with the Paediatric regulation (Regulation (EC) 1901/2006 as amended), which came into force in 2007 aiming to improve the health of children in Europe.

For further information about  EMEA's Paediatric Committee, you can visit the EMA website.