Report available on activities on medicines for children during 2011

25/07/2012

Report available on activities on medicines for children during 2011

The European Medicines Agency has prepared a report giving information on the companies that benefited from the rewards and incentives from the Paediatric Regulation during 2011.

The report, which is published each year by the European Commission, also examines situations where companies have failed to comply with the obligations in Regulation.

2011 saw the development of the European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) and enhanced levels of transparency over clinical trials carried out in children, both in the European Union Clinical Trials Register (EU-CTR) and the Article 45 Paediatric Studies Database.

The first application for a paediatric-use marketing authorisation (PUMA) was also submitted to the Agency during 2011, and subsequently authorised through the centralised procedure.