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).
PDCO's other roles include:
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.
Before start of Committee plenary. EMA has been publishing agendas for PDCO since its June 2012 meeting.
After Committee plenary where minutes are adopted. EMA has been publishing minutes for PDCO since its June 2012 meeting.
After Committee plenary. As of April 2022 and until further notice, PDCO no longer publishes meeting reports.