Novotech (Australia) Pty Limited
Human therapeutic - attenuation
This licence allows Novotech (Australia) Pty Limited to conduct a clinical trial of genetically modified human adenovirus for bladder cancer treatment in Australia. The vaccine is based on a modified human adenovirus. The GM treatment has been modified so that it reproduces preferentially in cancer cells and stimulates an immune response to the tumours. 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.
Outlines the Regulator’s decision to issue a licence following the assessment of this application.
FAQs on the licence application and the Regulator’s decision to issue a licence for this application.
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.
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.
Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.