EMA Issues Preliminary Paper on Pediatric Medicines

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-05-2016 15:27


The European Medicines Agency (EMA) has published a preliminary version of its draft reflection paper that outlines a framework for the extrapolation of clinical trial data from adults to children to support the authorization of new medicines for children.

Extrapolation of data aims to optimize the involvement of children in clinical studies, one of the objectives of the European Union Pediatric Regulation, by predicting how a medicine may work in children and adolescents on the basis of studies conducted in adults or other pediatric populations.

The draft reflection paper outlines a systematic approach to extrapolation of data from adults or other pediatric populations to children that is considered scientifically sound and reliable to support the authorization of a medicine. The framework sets out when, to what extent, and how extrapolation can be applied and validated. The reflection paper was developed to communicate the current status of discussions on extrapolation of data. It will provide a framework for discussion or clarification particularly in areas where scientific knowledge is fast evolving or experience is limited.

EMA is organizing a workshop on May 17 and 18 2016 to gather the views from experts and stakeholders on the topic. These discussions will contribute to the further development of the draft refection paper that is expected to be released for public consultation by the end of July 2016. The workshop will be broadcast live on the EMA website.

Source: European Medicines Agency


Thank you for reading DCAT Value Chain Insights (VCI), an information resource from the
Drug, Chemical & Associated Technologies Association (DCAT). 

Learn more and sign up to receive a complimentary subscription