Question Number: 275
PDR Number: SQ22-000646
Date Submitted: 21/11/2022
Department or Body: Department of Health
Question 244 Quadrant magazine is not a reputable medical journal. Even though the decision to provisionally approve molnupiravir was made on the basis of short-term efficacy and safety data, the data submitted to support the quality, safety and efficacy of molnupiravir was comprehensively evaluated and showed a positive benefit-risk ratio. Based on the totality of the genotoxicity data, molnupiravir was found to be of low risk for genotoxicity or mutagenicity in clinical use. This finding is clearly communicated in the Product Information (PI) document (available at: www.tga.gov.au/sites/default/files/ausparmolnupiravir-220207-pi.pdf) and Australian Public Assessment Report (available at: www.tga.gov.au/sites/default/files/auspar-molnupiravir-220207.pdf). Question 261 The TGA does not regulate how laboratories report results from pathology tests they perform, nor ways in which laboratories report test results. In 2021, the Australian Government did not make changes to how thyroid stimulating hormone and thyroid function tests are reimbursed under Medicare or how tests results should be reported.
