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Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products

We have adopted this International Scientific Guideline - EMA/CAT/80183/2014

Last updated

About this guideline

Adopted by the TGA: 08 June 2023

Overseas effective date: March 2018

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

 Multidisciplinary | Gene therapy

TGA annotations:

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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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