Production and quality control of medicinal products derived by recombinant DNA technology

We have adopted this International Scientific Guideline - 3AB1a

Last updated

9 January 2025

Overseas effective date: July 1995

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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