The European Commission has published a report delineating the scene for paediatric medicines after five years from the entry into force of EU Paediatric Regulation (Reg.1901/2006/EC).

The document entitled ‘Better medicines for children – from concept to reality’ highlights successes, areas of improvement and new challenges to improve the health of little patients in Europefollowing the Regulation.

The development of paediatric medicines has now become a more integral part of the overall development of medicinal products in the EU.

Some remarkable results have been achieved:

• 600 Paediatric Investigation Plans (PIPs) submitted to the Paediatric Committee;
• 31 new medicines authorised for paediatric use;
• 72 new paediatric indications for medicines already authorised;
• Around 350 paediatric trials per year, with an evident increase in the number of paediatric study participants, in particular for the age group from 0 to 23 months, normally not included in trials prior to 2008.

However, some provisions should be better implemented. For example, the new type of marketing authorisation introduced by the Paediatric Regulation, the Paediatric Use Marketing Authorisation (PUMA), failed its scope of increasing the availability of paediatric medicines, as only one PUMA has been granted.

Fondazione Gianni Benzi shares the idea that the Paediatric Regulation has really brought changes onto the regulatory scene for paediatric medicines, but further efforts are required to better protect the health of children in the EU.

The simplification of PIP applications and opinions, the greater involvement of children and parents in the opinion-making process, further incentives for PUMA and for paediatric trials, may really foster the development of medicines for children and meet the needs of little patients.

This topic will be discussed during the VI Foresight Training Course organised by the Gianni Benzi Foundation in collaboration with H-BIO Puglia.

For more information visit http://www.ema.europa.eu/ema/.