5. Special cases in marketing authorisations: Paediatric medicines

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.

The PDCO is not responsible for marketing authorisation applications for paediatric medicines, which is in the remit of the CHMP.