Role of the PDCO

Paediatric investigation plans

The 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 PDCO 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

The committee'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.

The 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.

PDCO rules of procedure

PDCO work plan 2024

Role and responsibilities of members and alternates, rapporteur and peer reviewers, experts and observers of the paediatric committee

Publication of PDCO agendas, minutes and reports

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 the PDCO plenaries since its June 2012 meeting. Before this, EMA only published monthly reports for the PDCO.

PDCO publication times

Agendas

Before start of Committee plenary. EMA has been publishing agendas for the PDCO since its June 2012 meeting.

Minutes

After Committee plenary where minutes are adopted. EMA has been publishing minutes for the PDCO since its June 2012 meeting.

Reports

After Committee plenary. As of April 2022 and until further notice, PDCO no longer publishes meeting reports.

Useful information

PDCO meetings in 2023, 2024, 2025 and 2026

Abbreviations used in EMA scientific committees and CMD documents, and in relation to EMA’s regulatory activities

Upcoming PDCO meetings

SEE ALL EVENTS

PDCO agendas

Agenda - PDCO agenda of the 20-23 February 2024 meeting

Agenda - PDCO agenda of the 16-19 January 2024 meeting

Agenda - PDCO agenda of the 12-15 December 2023 meeting


PDCO minutes

PDCO minutes of the 16-19 January 2024

PDCO minutes of the 12-15 December 2023 meeting

PDCO minutes of the 7-10 November 2023 meeting


PDCO meeting reports

PDCO meeting report of opinions on paediatric investigation plans and other activities 22-25 March 2022

PDCO meeting report of opinions on paediatric investigation plans and other activities 22-25 February 2022

PDCO monthly report of opinions on paediatric investigation plans and other activities 14-17 December 2021


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