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.

HumanRegulatory and procedural guidancePaediatricsResearch and development
EventHumanResearch and development

Massive amounts of data are generated on a daily basis that could potentially be harnessed to support medicines regulation. The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) set up a joint task force to describe the big data landscape from a regulatory perspective and identify practical steps for the European medicines...

HumanVeterinaryCorporateData on medicinesInnovationResearch and development

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.

HumanRegulatory and procedural guidancePharmacovigilanceResearch and development

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).

HumanVeterinaryRegulatory and procedural guidanceInnovationResearch and developmentScientific advice