Gene therapy product quality aspects in the production of vectors and genetically modified somatic cells

We have adopted this International Scientific Guideline - 3AB6a.

Last updated

3 June 2024

About this guideline

Overseas effective date: July 1995

Categories: Biologicals | Active substance | Manufacture and 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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