Potential breach of Listing Rules, page-3

I had a response from the TGA today, which is NOT confidential. So here it is:



Dear XXX,

Thank you for contacting the Therapeutic Goods Administration (TGA) concerning the availability of VIRALEZE™ Nasal Spray in Australia

The Australian Government is a strong supporter of health and medical research, its translation into new medical technologies, and the manufacture of those technologies into medical and pharmaceutical products.

As you are aware, the Government awarded funding of $1 million to Starpharma towards the development of VIRALEZE™ through the Biomedical Translation Bridge (BTB), an initiative of the Medical Research Future Fund. The BTB supports the accelerated development, and improved success, of early stage research that has commercial potential so that it can ultimately be commercialised into products and services that improve the health outcomes of Australians, as well as contributing to the Australian economy.

Like any medicine, before VIRALEZE™ can be lawfully supplied in Australia, it must be evaluated by the Therapeutic Goods Administration (TGA) and included on the Australian Register of Therapeutic Goods (ARTG).

For a medicine to be registered in Australia for the treatment or prevention of COVID-19, a sponsor is required to submit a comprehensive dossier, which consists of clinical studies, non-clinical/toxicology studies, chemistry, manufacturing, risk management, and other information. The Government is unable to compel a sponsor to make such an application, however it would be welcomed by the TGA at any time.

Once an application is accepted by the TGA, a formal evaluation is carried out in multiple stages by technical experts. This process involves obtaining further information and clarification from the applicant, and may include advice from an independent committee of external experts prior to finalisation and decision under the Therapeutic Goods Act 1989. The decision to approve a new therapeutic good is always made by the TGA on the basis that the benefits outweigh the risks for the intended population.

Applications to register new COVID-19 treatments and vaccines are being treated with the greatest priority by the TGA. Please also be assured that we are actively monitoring COVID-19 therapeutic development that is occurring both in Australia and around the world, and are regularly meeting with pharmaceutical companies to discuss progress and the application process. We are also part of a network of international regulators that meets regularly to discuss the development of COVID-19 therapeutics.

I hope this information is of assistance.

Yours sincerely

Kathy
Regulatory Assistance Service
Regulatory Guidance, Assistance and SME Section
Regulatory Engagement, Education and Planning Branch

Phone: 1800 020 653 Fax: 02 6203 1605
Email: [email protected]
Therapeutic Goods Administration
Department of Health
PO Box 100
Woden ACT 2606 Australia
www.tga.gov.au