- Report an adverse event or incidentPageInformation on how to report an adverse event or drug reaction for medicines, biologicals and medical devices.
- Manage a recallPageInformation about how recalls are regulated and what sponsors and manufacturers need to do.
- Manage a medicine shortagePageInformation for sponsors and manufacturers explaining what to do if there is a medicine shortage.
- Reporting medicine or vaccine deficiencies or defectsPageDeficiencies or defects of medicines thought to have arisen during manufacture, storage or handling.
- Industry information about specific safety alerts, recalls and shortagesPageCheck current information for sponsors and manufacturers about specific or ongoing safety issues.
- Medical Devices Vigilance Program - PilotPageFind out about the Medical Devices Vigilance Program (MDVP) pilot, which aims to support Australian medical device sponsors to comply with their post-market vigilance responsibilities.
More information
Resources
- Breast implants: things to considerGuidanceAll surgical procedures carry risk. A page for consumers considering getting implants.
- Medical device cyber security guidance for industryGuidanceGuidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
- IVD companion diagnosticsGuidanceGuidance on regulatory requirements for IVD companion diagnostics
Latest alerts
- Medicines containing turmeric or curcumin - risk of liver injurySafety alertsThe TGA has received reports of liver problems experienced by consumers taking medicines containing turmeric or curcumin.
- Ordine (morphine) oral liquid discontinuationMedicine shortage alertsFind out what the discontinuation of Ordine (morphine) oral liquid means for you.
- EvolutTM PRO+34mm Transcatheter Aortic Valve (TAV)Product recallsMedtronic Australasia is informing customers about the serious risk of valve infolding for EvolutePRO+ 34mm Transcatheter Aortic Valve (TAV), item code - EVPROPLUS-34US.
Latest articles
- EmpireLabz Australia Pty Ltd fined $115,500 for alleged unlawful advertising and supply of sport supplementsMedia releasesThe TGA has issued 7 infringement notices totalling $115,500 to the company for the alleged unlawful advertising and supply of sport supplement products containing banned substances.
- Product Information safety updates - April and May 2023Safety updatesMedicines Safety Update - Information for health professionals
- Queensland individual fined nearly $16,000 after allegedly importing unregistered nicotine vaping productsMedia releasesIt is alleged that the individual attempted to import six different types of nicotine vaping products (prescription medicines). The unapproved nicotine vaping products were intercepted by the Australian Border Force and have been seized and will be destroyed under advice from the TGA.
Latest publications
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2021PublicationsThe TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
- Pharmacovigilance Inspection Program metrics report: Jan - Dec 2020PublicationsThe PVIP aims to strengthen and broaden the TGA's post-market monitoring activities and protect public health
- Manufacturing Quality Branch annual reportsPublicationsThe TGA has published insights into recalls and GMP regulation for 2019-20.
Latest consultations
- Consultation: Product Information as a package insert in boxed injectablesClosed onConsultationPublic consultation on the Product Information (PI) as a package insert in boxed injectable products.