- PageReport an adverse event or incidentInformation on how to report an adverse event or drug reaction for medicines, biologicals and medical devices.
- PageManage a recallInformation about how recalls are regulated and what sponsors and manufacturers need to do.
- PageManage a medicine shortageInformation for sponsors and manufacturers explaining what to do if there is a medicine shortage.
- PageReporting medicine or vaccine deficiencies or defectsDeficiencies or defects of medicines thought to have arisen during manufacture, storage or handling.
More information
Resources
- GuidanceDAEN - medicines: Information for consumersQuestions and answers about the Database of Adverse Event Notifications - Medicines
- GuidanceBlack Triangle Scheme information for sponsorsInformation about what to include in the PI and CMI for products included in the Black Triangle Scheme.
- GuidanceSystem for Australian Recall Actions (SARA): about the search resultsInformation on the types of search results for the System for Australian Recall Actions (SARA) database
Latest alerts
- Safety alertsPholcodineThe TGA has decided to cancel the registration of pholcodine-containing medicines and is recalling them from pharmacies.
- Safety alertsNitrosamine impurities in medicines - Information for sponsors and manufacturersWe have published updated information on nitrosamine impurities, on the TGA response and requirements for medicine sponsors and manufacturers.
- Safety alertsCompatibility of tubing connectors and medical gas sourcesSafety advisory - Compatibility of tubing connectors and medical gas sources
Latest articles
- Media releasesJSHealth Vitamins fined $13,320 for alleged unlawful supply of a complementary medicineThe TGA has issued an infringement notice for $13,320 to Sydney company JSHealth Vitamins Pty Ltd for an alleged breach of the Therapeutic Goods Act 1989.
- Media releasesAustralian manufacturer fined almost $160,000 for allegedly breaching conditions of its medicines manufacturing licenceThe TGA has issued 12 infringement notices totalling $159,840 to a manufacturer of listed complementary medicines after a recent inspection of the company’s premises identified unacceptable manufacturing practices.
- Media releasesPholcodine cough medicines cancelled by the TGA and recalled from pharmacies for safety reasonsFollowing a safety investigation into pholcodine the TGA are cancelling 55 products (from the ARTG) and recalling them from pharmacy shelves due to an increased risk of anaphylactic reactions.
Latest publications
- PublicationsPharmacovigilance Inspection Program metrics report: Jan - Dec 2021The TGA Pharmacovigilance Inspection Program (PVIP) metrics report for 2021 is now available.
- PublicationsManufacturing Quality Branch annual reportsThe TGA has published insights into recalls and GMP regulation for 2019-20.
- Meeting statementsACMD meeting statement, Meeting 34, 22 June 2017Advisory Committee on Medical Devices
Latest consultations
- Closed onConsultationConsultation: Product Information as a package insert in boxed injectablesPublic consultation on the Product Information (PI) as a package insert in boxed injectable products.