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EMA to consult children when reviewing paediatric medicines

Consultation launched on how best to obtain views of young people

The European Medicines Agency (EMA) has announced plans to listen to the views of children and young people when reviewing medicines for paediatric indications.

A public consultation is now in process to discuss the Agency's concept paper for involvement, which seeks to create a framework outlining the best way to gain insight about children's drugs from the group they are actually intended to be used to treat.

“The objective of this concept paper is to develop a framework of interaction for the involvement of children and young people in the work of the PDCO, particularly: i) when and to what extent and ii) how their views can be sought, and iii) the manner in which their views can be applied,” the EMA said.

As such, it is recommended the framework includes an appropriate definition of what the Agency's paediatric committee expects from children and young people, as well as what their role would be within the committee.

Criteria for when children's views should be taken into account and a work plan for the practical aspects of involvement will also be set out.

Specific areas to cover include whether contact should be in person or via social media or online, and if meetings should cover general issues or be procedure-specific consultations.

The EMA proposes using its existing network of European patient organisations to find suitable children, with the hope this will help overcome challenges such as language barriers, difficulty of access, cultural differences and ill-informed notions about a child's level of understanding.

These organisations include Debra International, Alzheimer Europe, European Organisations for Rare Diseases, International Diabetes Federation Europe and Myeloma Patients Europe.

It is also suggested that member organisations of the paediatric committee who deal specifically with children, including European Patient Forum Youth Group, International Confederation of Childhood Cancer Parent Organisations and Matthew's Friends, could help identify children who might want to be involved.

“Consultation with children and young people across a wide age range, disease groups and across many Member States and cultural groups is considered essential,” said the EMA's concept paper, which is open for comments until November 19, 2012.

A further discussion by the paediatric committee will then take place in December 2012, with the expected date for adoption of outcome January 2013.

The consultation launch is the second major develop for paediatric medicine in recent weeks following the launch of the EMA's first inventory of research needs in children's drugs to highlight commercial possibilities where pharma can help fill gaps in R&D.

18th September 2012

From: Regulatory



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