As the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events.
Adverse events are unintended and sometimes harmful occurrences associated with the use of a medicine, vaccine or medical device. Adverse events include side effects to medicines and vaccines, and problems or incidents involving medical devices.
Examples of adverse events are any unfavourable and unintended sign, symptom or disease associated with the use of a therapeutic good. An abnormal laboratory finding could be one example of an unfavourable and unintended sign.
- PageReport an adverse event for medical devicesInformation on how to report an adverse event or serious public health threat or concern for medical devices.
- PageReport adverse events for medicines and biologicalsInformation on reporting adverse drug reactions, adverse events and significant safety issues for medicines and biologicals.
Guidance and resources
- PublicationsJoint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance studiesThese guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity