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334 result(s) found, displaying 76 to 100
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Safety updatesMedicines Safety Update - Information for health professionals
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Regulatory decision noticesFind out how listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2024, which commenced on 14 June 2024.
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Regulatory decision noticesThis instrument is the Therapeutic Goods (Poisons Standard) (Benzylpenicillin—Seqirus) Approval 2024.
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Safety updatesThe Product Information (PI) documents for antidepressants have been updated with warnings about sexual dysfunction continuing in some patients, after they stop using the medicines.
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Safety updatesMedicines Safety Update - Information for health professionals
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Regulatory decision noticesVoluntary cancellation of AstraZeneca COVID-19 vaccine: Vaxzevria
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Safety updatesMedicines Safety Update - Information for health professionals
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Safety updatesOur investigation into the risk of retinal vasculitis and/or retinal occlusive vasculitis in patients being treated with faricimab (Vabysmo) found that stronger warnings regarding this risk were needed in the Product Information (PI) and Consumer Medicine Information (CMI).
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Safety updatesInformation for health professionals about medicines with safety updates to their Production Information.
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Regulatory decision noticesFind out how listed medicine ingredients, and requirements for their use, have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2024.
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Regulatory decision noticesFrom 3 June 2024, we will be using a new Good Manufacturing Practice (GMP) guide for medicines, active pharmaceutical ingredients and sunscreens.
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Regulatory decision noticesThe TGA and Health Canada have signed a Memorandum of Understanding to further increase collaboration and reliance on Good Manufacturing Practice inspections conducted in countries outside each other's borders.
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Safety updatesMedicines Safety Update - Information for health professionals
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Regulatory decision noticesAnnouncement about the launch of the pilot Single Inspection Program, a global approach to Good Manufacturing Practice inspections of third country manufacturers.
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Regulatory decision noticesThis instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.
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Regulatory decision noticesThis instrument is made under Schedule 5A to the Therapeutic Goods Regulations 1990 and Schedule 4 to the Therapeutic Goods (Medical Devices) Regulations 2002.
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Safety updatesMedicines Safety Update - Information for health professionals
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Safety updatesMedicines Safety Update - Information for health professionals
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Regulatory decision noticesThis instrument is made under Schedule 5A of the Therapeutic Goods Regulations 1990 and Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2022.
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Regulatory decision noticesThis instrument is made under regulation 97 of the Therapeutic Goods Regulations 1990.
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Regulatory decision noticesThis instrument is made under subsection 19(7D) of the Therapeutic Goods Act 1989.
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Regulatory decision noticesWe have issued a notice to Pracmed Healthcare Pty Ltd to cease advertising indications related to weight loss surgery and cognitive function.
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Regulatory decision noticesWe've created a new GMP clearance Sponsor Information Dashboard (SID) to provide industry with current information about our processing times, workload and key messages. We have also updated our GMP clearance guidance.
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Regulatory decision noticesFind out about how GMP clearances for manufacturing sites in Bulgaria can now be assessed via the Mutual Recognition Agreement (MRA) pathway.
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Regulatory decision noticesInformation about GMP clearances issued via the MRA Pathway that expire on 31 December 2023 as well as information on the ongoing use of the GMP clearance questionnaire.