EMA publishes revised child medicines documents

Published: 18-Feb-2015
Regulatory

To reflect recent changes to European Commission


The European Medicines Agency (EMA) has published revised documentation relating to paediatric investigation plans (PIPs), reflecting recent changes to European Commission guidelines on the issue.

The guidance documents cover applications for the agreement or modification of a PIP; requests for waivers or deferrals and concerning compliance checks; and criteria for assessing significant studies.

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