The Paediatric Committee (PDCO) is the European Medicines Agency’s (EMA) scientific committee responsible for activities on medicines for children and to support the development of such medicines in the European Union by providing scientific expertise and defining paediatric needs.
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.
Role of the PDCO
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 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 is not responsible for marketing authorisation applications for medicines for use in children, which is in the remit of the CHMP.
For full details, see:
- PDCO: Rules of procedure
- PDCO work plan 2016
- Roles and responsibilities of members and alternates, rapporteur and peer reviewers, experts and observers of the Paediatric Committee
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