Report available on activities on medicines for children 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.
- Report to the European Commission on companies and products that have benefited from any of the rewards and incentives in the Paediatric Regulation and on the companies that have failed to comply with any of the obligations in this Regulation, covering the year 2011
- Paediatric Regulation
- Medicines for children