THE Therapeutic Goods Administration has released new guidance to assist sponsors of antibacterial prescription medicines to collect and provide appropriate information about the development of antibiotic resistance, both pre- and post-market.
As well as risk assessments about the development of antimicrobial resistance, the TGA advises that it requires Australian human antibiotic resistance data for all prescription antibiotics including topical and systemic items, as well as combination medicines containing antibacterial elements and composite packs with one or more antibacterial medication.
The guidance applies for new registrations as well as extensions of existing indications, new dose forms or changed dosage regimens.
See www.tga.gov.au.
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