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Regulatory Focus™ > News Articles > European Commission Releases First Report on the Pediatric Regulation

European Commission Releases First Report on the Pediatric Regulation

Posted 24 June 2013 | By Louise Zornoza

The European Commission today published a progress report on medicines for children covering the five years since the Pediatric Regulation came into force. Although it will take several more years to fully assess the impact of the legislation due to long drug development cycles, this preliminary review points to significant improvements in the pediatric medicines landscape: better and safer research, more products for children on the EU market and more information for parents and health professionals.

The main provisions of the Pediatric Regulation [(EC) 1901/2006] came into force in July 2008 with three objectives:

  • to ensure high-quality research into the development of medicines for children
  • to ensure, over time, that the majority of medicines used by children are specifically authorized for pediatric use with appropriate forms and formulations
  • to ensure the availability of high-quality information about medicines used by children.

According to the report, the European Medicines Agency (EMA) has approved 600 so-called pediatric investigation plans (PIPs) through the end of 2012, of which 33 of had been completed. A PIP is a research and development program designed to ensure that a new product is tested for its potential use in children and that those tests are an integral part of the overall development of the product. Since the Regulation came into force, 31 out of 152 new drugs have been authorized for pediatric use. By the end of 2011, 72 new pediatric indications had been approved for already authorized products. In addition, 26 new pharmaceutical forms were authorized for use in children.

To address the lack of adequate information on the use of medicines in children, the Pediatric Regulation requires that companies submit their data on safety and efficacy of products authorized for use by children to the competent authorities. Since 2008, companies have submitted more than 18,000 studies on roughly 2,200 medicinal products, and the analysis of those studies resulted in assessment reports on 140 active substances for medicines authorized nationally and 55 centrally approved medicines.

Commenting on the report, Tonio Borg, European Commissioner for Health and Consumer Policy said: "The Pediatric Regulation was adopted to address a very serious gap in healthcare. Despite the fact that children make up over 20 % of the population, many of the medicines prescribed to them were not specifically studied and authorized for use in children. I am pleased to see that in five years, progress has been made on research and the safety of children's medicines, and I hope that this marks the beginning of a much needed paradigm shift."

EC Progress Report on PIPs

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