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. For a complete list of these documents, see Scientific guidelines.

If you have comments on a document which is open for consultation, use the form 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


Collaborative approach

 
Other

Concept papers


Reflection paper


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