This search looks for keywords in all of the website’s content. Search tips
Filter by
HumanVeterinaryRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
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
HumanVeterinaryRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
The European Medicines Agency's scientific guidelines on specific types of products help medicine developers prepare marketing authorisation applications for human medicines.
HumanRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
VeterinaryRegulatory and procedural guidanceQuality of medicinesResearch and developmentScientific guidelines
This page lists the templates and forms required by companies wishing to apply for a paediatric investigation plan (PIP), deferral or waiver. Deadlines for submitting applications to the Paediatric Committee (PDCO) are also available below.
HumanRegulatory and procedural guidancePaediatricsResearch and development
EventHumanClinical trialsQuality of medicinesResearch and development
EventHumanInnovationRare diseasesPaediatricsResearch and developmentScientific advice
EventHumanInnovationRare diseasesPaediatricsResearch and developmentScientific advice
EventHumanPaediatricsResearch and development