Quality of biological active substances produced by stable transgene expression in higher plants

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Current effective version

Adopted guideline

Reference numberEMEA/CHMP/BWP/48316/2006
Published24/06/2008
Effective from01/02/2009
KeywordsTransgenic plants, molecular farming
DescriptionThis document explains how to achieve satisfactory quality for biological active substances produced using transgenic plant technology. It applies primarily to active substances intended for parenteral administration.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft guideline

In operation: 01/02/2009–present


Published: 24/07/2008


Published: 19/07/2006


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