5. Special cases in marketing authorisations: Paediatric medicines
1. Paediatric medicines
1.2. The PDCO
The Regulation’s main impact was the establishment of the Paediatric Committee (PDCO).
The PDCO's main task:
- to assess and accept or amend 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 tasks in relation to paediatric medicines include:
- assessing data generated in accordance with agreed PIPs;
- adopting opinions on the quality, safety or efficacy of a paediatric medicine, at the request of the CHMP or a regulatory authority in a European Union (EU) Member State (MS);
- advising MSs on the content and format of data to be collected through surveys on the uses of paediatric medicines;
- advising and supporting the development of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) of existing national European and extra EU networks, investigators and trial centres with specific expertise in the performance of studies in the paediatric population; Patient representatives are involved in the work of Enpr-EMA
- providing advice on questions on paediatric medicines, at the request of the EMA's Executive Director or the EC;
- establishing and regularly updating an inventory of paediatric medicine needs, in particular with a view to identifying research priorities
- advising the EMA and the EC on how to communicate the arrangements available for conducting research into paediatric medicines.