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The report summarises the areas of success and lessons learned of the implementation of the Paediatric Regulation since 2007 when it came into operation.
Between 2008 to 2011 13 new medicines as well as 30 new indications and 9 new pharmaceutical forms of existing medicines were authorised for use in children; these authorisations were made on the basis of Paediatric Investigation Plans (PIPs) agreed by the Agency's Paediatric Committee (PDCO).
An increasing number of ongoing clinical trials in children are conducted as part of an agreed PIP. By the end of 2011, the PDCO had adopted opinions on compliance for 29 agreed PIPs. This means that the full PIP was completed for these medicines. Full compliance with a PIP enables companies to request an extension of the duration of their patent for the medicine concerned. This is one of the main incentives of the Paediatric Regulation. National patent offices in 16 Member States granted a 6-month patent extension to 11 medicines, i.e. a total of 105 national Supplementary Protection Certificates (Article 36(1) of the Paediatric Regulation).
The report also identifies areas for improvement of the implementation of the Paediatric Regulation. Some paediatric therapeutic areas that affect predominantly children have been neglected in terms of pharmaceutical research. The report also notes that pharmaceutical companies do not make best use of the opportunities for early regulatory dialogue.
Awareness of the need for paediatric clinical research varies within the healthcare and academic community and despite increasing generation of data from clinical trials in children, there is still wide-spread off-label use of medicines in the treatment of paediatric patients. The Agency continues to simplify procedures and extend the support to applicants.