Two new quality standards, one for MDMA and another for psilocybine, have been published. These standards each specify the minimum quality requirements for both the active pharmaceutical ingredient (API) and…
Nitrosamines in medicinesWe have published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent EMA updated information. The changes include additional clarification for sponsors and manufacturers…
The Therapeutic Goods Administration (TGA) has made the decision not to register lecanemab (LEQEMBI) for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and Mild…
SummaryWe have received Australian reports of Guillain-Barré Syndrome (GBS) following Shingrix vaccination.After investigating this issue and seeking advice from an expert panel, the Product Information (PI) and Consumer Medicine Information…
The Therapeutic Goods Administration (TGA) has taken further action to combat the unlawful sale of vapes in Queensland, issuing an infringement notice totalling $18,780 to a retailer for the unlawful…
