European Commission report highlights successes of the first five years of the EU Paediatric Regulation

The European Commission has addressed its general report on experience acquired as a result of the application of Regulation (EC) No 1901/2006 on medicinal products for paediatric use to the European Parliament and the Council. The report has been published today and is entitled 'better medicines for children – from concept to reality.'

The European Medicines Agency is pleased to note that the efforts and the achievements of the Agency and its Paediatric Committee are acknowledged in the report, particularly those on the timely initial implementation of the Regulation, and the flexibility demonstrated in the subsequent phase, when adopting simplifications and discussing innovative approaches (including innovative trial designs and extrapolation).

The report also recognises the important contribution of the national competent authorities in European Union (EU) Member States in assessing a high number of paediatric clinical-trial results, because companies holding data on the safety or efficacy of authorised products in the paediatric population are now required by the Paediatric Regulation to submit these studies to the competent authorities.

Among the successes of the Regulation so far, the report highlights:

• the marked increase in the number of neonates included in clinical trials;
• the cooperation with other international authorities such as the United States Food and Drug Administration to allow global product development;
• the already clearly visible results in terms of child-appropriate pharmaceutical forms.

Additionally, the new indications and new medicines authorised for children are mentioned in the report, as detailed in successes of the Paediatric Regulation after five years , recently published by the Agency.

Considering the significant number of deferrals granted, the Commission and the Agency expect an even greater number of new medicines and indications for children in the next few years.

The report concludes that paediatric development has now become a more integral part of the overall development of medicinal products in the EU, with the Regulation working as a major catalyst to improve the situation for young patients. While some areas for improvement have been identified, such as the low uptake of the paediatric-use marketing authorisation (PUMA) by companies, the Agency, together with the Commission, intends to fine-tune the current implementation of the Regulation.