The European Medicines Agency (EMA) has launched an initiative that offers free-of-charge early paediatric interaction meetings with medicines developers to stimulate early dialogue on the development of their medicines for use in children. A one-year pilot phase is starting today.

The new initiative aims to encourage discussions on the paediatric needs that could be addressed with a specific medicine well before the submission of a paediatric investigation plan (PIP).

Medicines developers that wish to participate in the pilot phase are invited to provide information on their medicine using a specific form and send it to paediatrics@ema.europa.eu.

In the European Union, pharmaceutical companies are obliged to develop all new medicines also for use in children. The paediatric development is detailed in a PIP that needs to be agreed with EMA’s Paediatric Committee (PDCO).

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/06/news_detail_002348.jsp&mid=WC0b01ac058004d5c1