Scientific guidelines: paediatrics

This page includes the European Medicines Agency's scientific guidelines that are specifically relevant to the development of medicines for children.

These documents help applicants prepare paediatric investigation plans and other development programmes in children, supporting authorisation in children. They are produced through a collaboration of several Committees and Working Parties of EMA, in particular by the Paediatric Committee (PDCO) and the Committee for Medicinal Products for Human Use (CHMP).

Information of paediatric relevance may also be included in general or disease-specific guidelines, not listed here. For a complete list of these documents, see Scientific guidelines.

If you have comments on a document which is open for consultation, use the Microsoft Office document iconform for submission of comments on scientific guidelines .

For a complete list of scientific guidelines currently open for consultation, see Public consultations.

Quality

Guidelines


Non-clinical

Guidelines


Clinical efficacy and safety

Guidelines


Reflection papers


Concept papers


Project reports


Other

Collaborative approach


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