Guideline on the quality of biological active substances produced by stable transgene expression in higher plants

We have adopted this International Scientific Guideline - EMEA/CHMP/BWP/48316/2006

Last updated

22 August 2024

About this guideline

Overseas effective date: 1 February 2009

Categories: Biologicals | Active substance | Manufacture, characterisation and control of the active substance

TGA Annotations: Nil

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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