The European Medicines Agency (EMA) and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published a joint action plan to support the development of medicines for children in Europe.
The action plan addresses challenges identified by the European Commission’s ten-year report on the implementation of the Paediatric Legislation and takes also into account the ideas on how to better apply the Paediatric Regulation to boost the development of medicines for children, collected during the multi-stakeholder workshop organised by EMA and the European Commission in March 2018.
The ten-year report on the implementation of the Paediatric Regulation released by the European Commission, showed that the number of medicines developed for children increased during this period. However, it also revealed specific challenges, like developing medicines for diseases that only affect children or for diseases that manifest differently in adults and children. The report also highlighted that the development and later availability at patients’ bedside of paediatric medicines is often delayed when compared with adult medicines.
Based on this analysis, the report identified a number of areas where short-term actions could address the identified shortcomings under the current legal framework. In order to follow up on the report’s conclusions the EC and the European Medicines Agency (EMA) have developed a detailed plan to boost the development of medicines for children in Europe, in consultation with all relevant stakeholders.
The actions in the plan are clustered around five key areas:
- identifying paediatric medical needs;
- strengthening cooperation between decision makers;
- ensuring timely completion of paediatric investigation plans (PIPs);
- improving the handling of PIP applications;
- increasing transparency around paediatric medicines.
The new joint action plan was also presented by the Enpr-EMA Chair Mark Turner in the occasion of the General Assembly meeting of EPTRI (European Paediatric Translational Research Infrastructure) that took place in Athens on 9-10 October 2018.
EPTRI project is a European funded project coordinated by CVBF (Consorzio per Valutazioni Biologiche e Farmacologiche), aimed to propose developmental models for a future research infrastructure focused on paediatric medicines, integrating technology-driven aspects with clinical trials.
Further information is available here.