Paediatric Committee (PDCO)

Paediatric investigation plans

PDCO's main role is to assess the content of paediatric investigation plans (PIPs), which determine the studies that companies must carry out in children when developing a medicine. This includes assessing applications for a full or partial waiver and for deferrals. 

The committee is not responsible for marketing authorisation applications for medicines for use in children, which is in the remit of the Committee for Medicinal Products for Human Use (CHMP).

Expert support

PDCO's other roles include:

• assessing data generated in accordance with agreed PIPs;
• adopting opinions on the quality, safety or efficacy of a medicine for use in the paediatric population, at the request of the Committee for Medicinal Products for Human Use (CHMP) or a medicines regulatory authority in a European Union (EU) Member State. The PDCO can give an opinion if the data have been generated in accordance with an agreed PIP;
• advising Member States on the content and format of data to be collected through surveys on the uses of medicines in children;
• advising and supporting the development of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA);
• providing advice on questions on paediatric medicines, at the request of the Agency's Executive Director or the European Commission;
• establishing and regularly updating an inventory of paediatric medicine needs;
• advising the Agency and the European Commission on how to communicate the arrangements available for conducting research into paediatric medicines.

PDCO was established in line with the Paediatric Regulation, which came into effect in 2007, to improve the health of children in Europe by facilitating the development and availability of medicines for children aged 0 to 17 years. 

For full details, see the PDCO rules of procedure, work plan and roles and responsibilities.

EMA's Paediatric Committee (PDCO) meets once a month. 

EMA publishes the agendas, minutes and reports of the plenary meetings. 

EMA has been publishing the agendas and minutes of PDCO plenaries since its June 2012 meeting. 

Before this, EMA only published monthly reports for PDCO.

Starting with September 2024, EMA is publishing the PDCO's agendas and minutes in Excel format in order to facilitate the analysis of data. This follows the transition of the paediatric submission procedures to IRIS, a secure online platform for handling product-related scientific and regulatory procedures with EMA. It is also in the context of the digitalisation of EMA's activities. You can share your feedback on your experience with the new agenda format at pdcosecretariat@ema.europa.eu.