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On 15th November, the EC launched a public consultation to get views and feedback from stakeholders, to support the Commission in drafting its second report on the Paediatric Regulation. The launch of this consultation comes exactly 10 years after the first consultation. The consultation will be open for 5 days and feedback will be centralised through the EMA website. The feedback received will form an integral part of the Commission’s final report assessing the impact of the Paediatric Regulation on public health and the pharmaceutical industry, which is expected to be published in 2017.
The overall objection of the Paediatric Regulation was 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 this month is based on a report prepared by the European Medicines Agency (EMA) and its Paediatric Committee (PDCO). The data collected from 2007 to 2015 by EMA and Member States shows that the regulation has resulted in several improvements in paediatric medicine development.
During the period of 2012 to 2014 the Paediatric Regulation has led to more medicines and new indications being authorised for children in the EU than preceding years prior to the regulation. For example, medicines to treat certain rheumatology conditions in children, infectious diseases such as chronic hepatitis C and HIV infection, hypertension and paediatric cancers like acute lymphoblastic leukaemia are now available on the basis of studies conducted in children.
Peadiatric therapies are becoming an integral part of medicines development
Clinical trials in children initiated as part of an agreed PIP (Paediatric investigation plan) now represent about 30% of paediatric trials recorded in the EU Clinical Trials database (EudraCT). Additionally, the European Network for Paediatric 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 recognised for their paediatric 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. This area of regulatory development will lead to a more streamlined approach across national agencies when dealing with medicines developed solely for children or with paediatric indications. ELC has a strong track record regarding development protocols and clinical strategies and our experts can help leverage the changes to this rapidly developing area.