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Monitoring, safety and shortages
Your responsibilities do not stop once your therapeutic good is on the market. Please find information below about further monitoring of your product, reporting adverse events and shortages.
- 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.