The European pediatric regulation

FEBRUARY 20, 2017 – Public consultation on the European Pediatric Regulation: we answered to the survey on the evaluation of the Pediatric Regulation, based on the urgent need for new drugs against pediatric cancers and making concrete proposals so that pharmaceutical laboratories no longer obtain derogation on drug development which could have a benefit in childhood cancers.

Voted by the European Parliament in December 2016, our proposals developed with SIOPE and Unite2cure are :

– the obligation to create pediatric investigation plans on the mechanism of action of the drug and its potential benefit to children – not the type of adult disease for which it’s developed.

– To set up a mechanism for choosing the best possible drug, and prioritize among  industrials medications, those who ensure the best for children’s needs with rare cancers.

– To reduce drug access times by enforcing the timing of PIP submission as outlined in the Regulations (end of phase 1 in adults)

– To make rewards more efficient and flexible by giving priority to industrials which submit PIPs without delay or achievespecific developments of pediatric diseases.

Otherwise, we also ask :

-to break the dogma of 18-year-olds including adolescents in adult clinical trials

– Simplify the procedure for the submission of PIPs



To view our response to the public consultation, click here