The 2006 Paediatric Regulation aimed to reduce the level of off-label use of medicines in children and increase the number of medicines specifically developed and tested for children.
The European Commission conducted a first review of stakeholder’s experience of the Paediatric Regulation in 2013 and noted some encouraging progress, but due to the long term nature of drug development, recommended that this was followed up in 2017.
The Public Consultation has just ended. It is fair to say that the 75 respondents reported a mixed experience. It is widely recognised that some therapeutic areas have seen important progress, but availability of products specifically for children is variable and the regulatory process could be further streamlined. In particular, many respondents viewed PUMA (Paediactric Use Marketing Authorisation) as a disappointment, due in part to the lack of sufficient incentives and rewards.
A summary of the replies together with the responses themselves are available here.
The full Commission Report will be published later this year.