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Overview of how TGA manages medicine adverse event reports
The TGA receives adverse event reports from consumers, health professionals and members of the therapeutic goods industry. Once the TGA has received an adverse event report about a medicine, it is:
- given a case number
- entered into the internal TGA database
- reviewed and coded by the TGA with the relevant terms from the Medical Dictionary for Regulatory Activities (MedDRA)
- relevant information copied from the internal TGA database to the publically accessible Database of Adverse Event Notifications - medicines after a 14 day lag for new cases.
The majority of reports are submitted voluntarily. However, medicine sponsors are required under the Therapeutic Goods Act 1989 to report serious adverse events suspected of being related to one of their products.
Entry into the database
All reports that contain the minimum data requirements are entered into the database. The minimum data requirements are:
- a means of identifying the patient. This may be the patient's initials or a patient ID number (not the patient's full name), their age and/or gender
- a description of the adverse event
- the name of the medicine/s or vaccine/s that are thought to be related to the adverse event
- a means of identifying the reporter.
The information in the internal TGA database is analysed by the TGA for patterns of adverse events that may indicate a safety issue (signal detection). The detected safety signal is then assessed and appropriate actions are taken to manage the risks.
In some cases, the TGA requests further information from the reporter if it could assist in assessing the possible role of the medicine, including vaccines, in the reported event, or if the report is of an event of special interest to the TGA.
The TGA works with the National Centre for Immunisation Research & Surveillance (NCIRS) on adverse events relating to immunisation including the preparation of regular national AEFI (adverse events following immunisation) surveillance reports. These annual reports have been published in Communicable Diseases Intelligence since 2003.