The closing report of the European Medicines Agency (EMA) and European Commission (DG Health and Food Safety) action plan on paediatrics has been recently published.
During the past four years, several initiatives were taken to increase the efficiency of the paediatric regulatory processes and promote the development of paediatric medicines.
The paediatric action plan has brought several improvements to the development of paediatric medicines:
- Raised awareness for unmet medical needs of the paediatric population – EMA and relevant key stakeholders have identified and raised awareness on the areas where medicines for children are particularly needed, with a goal to shift the research agenda to these areas.
- Facilitation of the implementation of paediatric investigation plans (PIPs) for new medicines – a pilot phase for a ‘stepwise PIP’ agreement has been launched. Under this framework, it will be possible in certain cases to agree on a partial development programme, conditional on the development of a full PIP once evidence becomes available over time.
- Increased alignment of data requirements between decision-makers – the European network of paediatric research at EMA (Enpr-EMA) has been working to align international requirements for paediatric clinical trials authorisation and standards, particularly with the US Food and Drug Administration (FDA).
TEDDY Network is proud to be a member of the Coordinating Group at Enpr-EMA and will continue working for promoting research into medicines for children.
More information about this news is available here.