The Paediatric Committee (PDCO) is the committee at the European Medicines Agency that is responsible for assessing the content of paediatric investigation plans 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).
- See the full overview of the PDCO's role.
The PDCO is composed of:
- five members of the Committee for Medicinal Products for Human Use (CHMP), with their alternates. These members are appointed by the CHMP itself;
- one member and one alternate appointed by each European Union (EU) Member State that is not represented by the members appointed by the CHMP;
- three members and alternates representing healthcare professionals;
- three members and alternates representing patient associations.
The members of the PDCO are appointed for a renewable period of three years. The chair is elected from its members.
- See the full meeting plan for the PDCO.
How useful is this page?
Average rating:Based on 24 ratings
Add your rating:
- See all ratings
15 ratings2 ratings2 ratings4 ratings1 ratings