EMA child medicine committee unveils plans for the future
Aims to increase the involvement of children and their parents
The Paediatric Committee of the European Medicines Agency (EMA) has unveiled future plans to strengthen and expedite the supervision of child medicine development in the European Union.
In a report, it said working with EMA as a whole, it would increase the involvement of children and their parents in assessing paediatric medicines. The committee said it was currently reviewing the comments received in a 2012 EMA public consultation on the subject.
Meanwhile the committee plans to simplify applications and opinions required within the paediatric investigation plans for EU child medicines market approval applications. It said it would make its operations more transparent and publish full opinions, including key elements of relevant studies. Also, it would also create new summaries ‘written in simple language for all stakeholders’.
The committee will expand the role of the European Network of Paediatric Research at the European Medicines Agency in helping organise clinical trials involving children. And it will increase monitoring of paediatric investigation plan work, including analyses of pharmaceutical company reports including updates on paediatric studies.
Committee chairman Daniel Brasseur said: ‘In the near future, sick children can expect to be treated like adults with medicinal products having been formulated and investigated according to their specific needs.’
He said there was a constant dialogue between the committee and academia, the pharma industry and parent associations, which had enabled the committee to come closer to this goal.
‘Further efforts are now underway to optimise the activities and enlarge the scope of paediatric diseases deserving proper treatment,’ he added.