This page provides detailed guidance for companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver, as well as for companies that already have an agreed PIP.

EudraVigilance is a system for monitoring the safety of medicines. Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues.

A range of services is available from the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA) and European Commission to support innovative medicines and associated technology developments in the European Union (EU).

The European Medicines Agency (EMA) publishes opinions on the qualification of innovative development methods and letters of support for novel methodologies that have been shown to be promising in the context of research and development into pharmaceuticals.

PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach...

The European Medicines Agency's scientific guidelines on the clinical evaluation of human medicines used to treat or prevent infections help medicine developers prepare marketing authorisation applications.

The European Medicines Agency's scientific guidelines on biostatistics help medicine developers prepare marketing authorisation applications for human medicines.