Regulatory Focus™ > News Articles > EMA Opens Consultation on Proposed Pediatric Development Framework

EMA Opens Consultation on Proposed Pediatric Development Framework

Posted 18 September 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) is opening a public consultation on a newly released report in which it calls for a new framework to incorporate the views of children into the review of clinical trial plans before the Pediatric Committee (PDCO).

The report, "Concept paper on the involvement of children and young people at the PDCO," is aimed at meeting the requirements of the Charter of Fundamental Rights of the EU, which states that member states should take into account the views of children, particularly when such views are concerned with their well-being.

EMA's report notes a number of challenges in the way of immediately adopting such a policy, including access to the advice of children, ethnic and cultural differences, maturity, the ability of a child to express his or her thoughts and the biases of adults against listening to children.

A framework proposed by PDCO aims to provide a structure through which such concerns can be met while allowing for the concerns of children to be raised. In particular, PDCO wants to consult with children-generally-about the evaluation of individual Paediatric Investigation Plans, the definition of significant therapeutic needs and therapeutic areas, clinical assessments used as trial endpoints, the amount of testing done in trials, preferences on the design of clinical trials, preferred routes of administration for therapies and the palatability of medicines.

EMA's consultation is looking for feedback on a number of areas, such as the main objectives for engaging with children, how to "identify and approach" children to consult with, how to obtain their views and how to apply their thoughts.

The deadline for comments on the proposal is 19 November 2012, and a framework is expected to be published in January 2013.


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