POLICY-RELATED UPDATES: Paediatric Medicines Regulation updates

SIOPE emphasised the Paediatric Strategy Forums jointly implemented by ACCELERATE and EMA as a model to share information and advance learning in a pre-competitive setting

The European Commission published its evaluation report on the EU Paediatric Medicines Regulation on October 2017. ¬†For many months prior, SIOPE and Unite2Cure actively advocated to bring changes to the legislation and foster the development of more anti-cancer medicines for children. ¬†These efforts found a reflection in the European Commission report ‚Äď childhood cancer was clearly identified as an area where improvements were needed. ¬†The report did not propose to amend the current legislation but put forward another round of policy evaluation as well as a process to streamline the implementation of the Regulation as it currently stands.

On 20 March 2018, the European Medicines Agency (EMA) and the European Commission held a multi-stakeholder workshop focusing on implementation.  Both SIOPE and Unite2Cure representatives were official speakers at this meeting, putting the spotlight on the urgent needs and initiatives in the paediatric cancer sector.  SIOPE emphasised the Paediatric Strategy Forums jointly implemented by ACCELERATE and EMA as a model to share information and advance learning in a pre-competitive setting.  Other issues that speakers called for included continued public awareness raising, breaking the 18-years dogma for participation in clinical trials, FDA and EMA alignment, earlier submission of Paediatric Investigation Plans, and evaluating the class waiver list.

EMA and European Commission Multi-stakeholder workshop to further improve the implementation of the Paediatric Regulation:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/events/2018/01/event_detail_001570.jsp&mid=WC0b01ac058004d5c3