EMEA finalises paediatric guideline

Published: 28-Jul-2006

The European Medicines Agency (EMEA) has finalised a guideline on pharmacovigilance for paediatric medicines.


The European Medicines Agency (EMEA) has finalised a guideline on pharmacovigilance for paediatric medicines.

EMEA defines the paediatric population as comprised of newborns, up to children 18 years of age. It is the first guideline to focus exclusively on the issues of safety of medicines in children, and it is meant to help prepare for the new regulation of medicinal products for paediatric use that enters into force later this year.

This guideline is directed towards marketing authorisation holders and competent authorities and is relevant to those involved in paediatric clinical trials. It also applies to off-label, licensed and unlicensed uses.

However, the new guideline does not address the paediatric use of vaccines - a separate CHMP Guideline on the Conduct of Pharmacovigilance for Vaccines is under development.

The guideline under development for the paediatric use of vaccines aims to clarify and emphasise the particular aspects of pharmacovigilance and risk minimisation that are relevant to the paediatric population.

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