Scientific guidelines: paediatrics

  • Email
  • Help

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.





Clinical efficacy and safety


Reflection papers

Concept papers

Project reports


Collaborative approach


How helpful is this page?

Average rating:

 Based on 64 ratings

Add your rating:

See all ratings
12 ratings
12 ratings
11 ratings
13 ratings
16 ratings

Tell us more