Scientific guidelines: paediatrics

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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. A complete register of all scientific guidelines published online by the Agency is available.

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

Quality

Guidelines


Non-clinical

Guidelines


Clinical efficacy and safety

Guidelines


Reflection papers


Concept papers


Collaborative approach


Other

Concept papers


Reflection paper


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