Sponsors are advised that consultation with the Office of the Gene Technology Regulator (OGTR) is required for applications covered by this guideline, as is described in Section 30C of the Therapeutic Goods Act 1989.
Where relevant, sponsors should consider in-process tests to ensure transcription or translation fidelity.
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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