Time for action!, page-42

Headline - TGA clarifies regulatory pathways for drug-device combination products Oct. 18, 2022 By Tamra Sami

Australia’s TGA has opened a consultation on drug-device combination products to help sponsors understand the regulatory pathway through which their products will likely pass since these combination products may not fit within existing definitions for drugs, biologicals or medical devices.

Link -https://www.tga.gov.au/resources/consultation/consultation-draft-guidance-boundary-and-combination-products-medicines-medical-devices-and-biologicals

Joohnno - Board Strategy:

Starpharma has been correct in its view that Viraleze is a device (refer Shareholder letter), after initial disagreement by the regulator, poorly played out in the press by the TGA. Starpharma's Viraleze application met guidelines for device classification which existed at the time of the application.

A decision by TGA on Viraleze has gone on for atleast 12 months in Australia, and IMHO a "consultation" on Draft pathway guidance may further delay any approval or rejection of Viraleze. This reflects poorly on all involved should this matter languish further. Our Board has indicated that they are unable to understand the delay involved.

In the context of a pandemic the likes of which has never been seen before, I suspect that Starpharma's strategy to be patient and diplomatic with the regulator has run its course. Ofcourse Im assuming Starpharma has done all that is required of them by the TGA.

Surely this is and was a public health matter where time is / was critical. Viraleze is approved in the UK by MHRA, an organisation with which the TGA has a close collaborative relationship.

Lets assume the time lag is due to the TGA - What would be your recommended change in strategy be to the Board, if any ?