The Paediatric Committee's (PDCO's) main role is to assess the content of paediatric investigation plans (PIPs) and adopt opinions on them. This includes the assessment of applications for a full or partial waiver and assessment of applications 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 for 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 the communication of arrangements available for conducting research into paediatric medicines.
The PDCO is not responsible for marketing-authorisation applications for medicines for use in children. This remains within the remit of the CHMP.
- For full details on the Committee's responsibilities and composition and on the roles of its members, see the Paediatric Committee rules of procedure.
- The roles and responsibilities of members and alternates, rapporteurs, peer reviewers, observers and experts at the PDCO meetings are described in PDCO – Roles and responsibilities at PDCO meetings.
More information on the initiatives taken by the PDCO and on how to apply for PIPs, waivers and deferrals is available under paediatric medicine development.
How useful is this page?
Average rating:Based on 16 ratings
Add your rating:
- See all ratings
8 ratings4 ratings1 ratings2 ratings1 ratings