Licence details
Ferring Pharmaceuticals Pty Ltd
Adenovirus
Human therapeutic - replication incompetent and expression of human interferon alfa-2b protein
This licence allows Ferring Pharmaceuticals Pty Ltd to import, transport, store and dispose of a genetically modified (GM) therapeutic, nadofaragene firadenovec, as part of its commercial supply in Australia for bladder cancer treatment. Use of the GM therapeutic in people will also require approval from the Therapeutic Goods Administration (TGA), which has responsibility for assessing the quality, safety and efficacy of any medicine intended for use in people in Australia. The import of the GM therapeutic will require a permit from the Department of Agriculture, Fisheries and Forestry.
The licence is for dealings as part of ongoing commercial supply of nadofaragene firadenovec. 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. However, general conditions have been imposed to ensure that there is ongoing oversight of the commercial supply. Supply of the GM therapeutic will also follow the Australian code of good wholesaling practice for medicines in schedules 2, 3, 4 & 8 (2011), the WHO’s Good storage and distribution practices for medical products (2020), and the Standard for the Uniform Scheduling of Medicines and Poisons (as current) which all provide appropriate controls. These controls were considered in the risk assessment. Any unused GM therapeutic or waste material will be disposed of in accordance with local requirements for clinical waste.
The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.
Documents
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.