TGA hits pause on two consultations

Australia’s Therapeutic Goods Administration (TGA) reported a delay to Dec. 2, 2020, for the closing of the comment period for two consultations, one each for adverse event (AE) reporting and for unique device identifiers. The notice for AE reporting states that the proposed enhancements were discussed in some detail on three webinars taking place between late October and early November 2020, and that the proposal would substantially shrink the types of incidents that would be exempt from reporting. The closing comment period was initially set for Nov. 18, 2020. The comment period for the UDI consultation was also initially set for Nov. 18. This consultation addresses several considerations, including whether TGA should align its UDI policies with those of the International Medical Device Regulators Forum.

HQO recommends home UVB therapy

Health Quality Ontario (HQO) said in a November health technology assessment that the province should publicly fund the use of home narrowband ultraviolet B (UVB) phototherapy as an option for patients with photoresponsive skin conditions. The conditions in question include psoriasis, eczema, vitiligo and cutaneous T-cell lymphoma, and HQO said this type of therapy is generally better tolerated than psoralen plus UVA phototherapy. Home UVB therapy was credited with effectiveness equal to clinically administered therapy, and is likely to be cost effective compared to clinical treatment as well. The aggregate annual spend for home UVB therapy was estimated at CA$2 million (CA$700,000 for psoriasis and CA$1.3 million for other photoresponsive conditions).

Health Canada announces testing advisory panel

Health Canada (HC) announced that the Minister of Health has established a testing and screening advisory committee for consultation on policy questions such as testing strategies that can be deployed in workplaces and at “the border.” The panel would report directly to the Minister of Health rather than to HC, and will not advise on regulatory matters. The notice makes no mention of the COVID-19 pandemic, however. HC also announced that it will form an industry advisory panel to draw on industry insights into matters such as testing, contact tracing and data management.

No Comments