DIR 179

Clinical trial with a genetically modified Vaccinia virus based treatment for solid cancerous tumours

Licence details

Licence number:
DIR 179
Licence status:
Limited and controlled

Novotech (Australia) Pty Limited

Parent organism:

Vaccinia virus

Modified trait:

Human therapeutic

Licence issue date:

This licence allows Novotech (Australia) Pty Limited to conduct a clinical trial of their genetically modified Vaccinia virus based treatment for solid cancerous tumours in Australia. The GM treatment is based on Vaccinia virus, which was used as a vaccine during the global smallpox eradication campaign. The GM treatment has been modified by deletion of several genes so that it multiplies in and then kills cancerous tumour cells without affecting healthy cells. Clinical trials in Australia are also overseen by the Therapeutic Goods Administration (TGA) and so Novotech will also need approval from TGA before the trial can start.

The Regulator has not imposed any specific measures to manage risk because there is negligible risk to the health and safety of people or the environment. Clinical trials in Australia must also follow the National Statement on Ethical Conduct in Human Research and the Guidelines for Good Clinical Practice of the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Novotech will also need permission from the Department of Agriculture, Water and the Environment to import the GM vaccine.

The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.

Date application received:
RARMP open for public consultation:
RARMP closed for public consultation:


Licence decision - notification

Outlines the Regulator’s decision to issue a licence following the assessment of this application.

Licence decision - Q&A

FAQs on the licence application and the Regulator’s decision to issue a licence for this application.

Risk assessment and risk management plan - summary

A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.

Risk assessment and risk management plan - full version

The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.

Licence conditions

Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.

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