EMA just published a new guidance for applicants "Procedural advice on paediatric applications". This document describes which drugs are and aren't covered by the the foundational 2006 legislation. It reiterates the aim of the regulation:
"ensure that medicines for use in children are of high quality, ethically
researched and authorised appropriately; and improve the availability of information on the use of medicines for children. It aims to achieve this without subjecting children to unnecessary trials or delaying the authorisation of medicines for use in adults."
The remainder of the guidance lays out the requirements and process for paediatric applications.
#EMA #pediatricguidance
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/procedural-advice-paediatric-applications_en.pdf
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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