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

Current effective version

PDF iconAdopted guideline

Reference number EMEA/CHMP/BWP/48316/2006
Published 24/06/2008
Effective from 01/02/2009
Keywords Transgenic plants, molecular farming
Description This 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

PDF iconAdopted guideline


PDF iconOverview of comments


PDF iconDraft guideline

In operation: 01/02/2009–present


Published: 24/07/2008


Published: 19/07/2006

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