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The European Commission launches a public consultation on the Pediatric Regulation

Friday, November 18, 2016

The European Commission (EC) has launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Pediatric Regulation after nearly 10 years of implementation. The consultation is open until February 20, 2017. Stakeholders should send their comments directly to the EC by accessing the consultation page.

The feedback received will form an integral part of the Commission’s final report assessing the impact of the Pediatric Regulation on public health and the pharmaceutical industry, which is expected to be published in 2017.

The Pediatric Regulation came into force in the European Union (EU) on January 26, 2007. Its objective is to improve the health of children in Europe by facilitating the development and availability of age-appropriate medicines for children, and by increasing available information on the use of medicines for children.

The consultation launched today is based on a report prepared by the EMA and its Pediatric Committee (PDCO). The data collected from 2007 to 2015 by EMA and Member States show that the regulation has resulted in several improvements in pediatric medicine development.

A comparison of data collected between 2004 and 2006, immediately before the regulation came into force, and data collected between 2012 and 2014, shows that the Pediatric Regulation has led to more medicines and new indications being authorized for children in the EU. From 2004 to 2006, 31 new medicines and new indications were centrally authorized for pediatric use. From 2012 to 2014, this number more than doubled to 68 new medicines and new indications. For example, medicines to treat certain rheumatology conditions in children, infectious diseases such as chronic hepatitis C and HIV infection, hypertension and pediatric cancers like acute lymphoblastic leukemia are now available on the basis of studies conducted in children.

Considering children’s needs is an integral part of medicine development

By the end of 2015, the PDCO had adopted 860 opinions for pediatric investigation plans (PIP). PIPs are the main tool of the regulation to ensure that previously unmet therapeutic needs in children are researched and appropriate medicines are developed.

Clinical trials in children initiated as part of an agreed PIP now represent about 30% of pediatric trials recorded in the EU Clinical Trials database (EudraCT). Additionally, the European Network for Pediatric Research at the EMA (Enpr-EMA) was set up to facilitate the conduct of clinical studies in children. Enpr-EMA is an umbrella network of 38 national and international networks recognized for their pediatric research experience. It acts as a platform for sharing good practices as well as a pan-European voice for promoting research into medicines for children.

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