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Australia Therapeutic Goods Administration (TGA)
The Therapeutic Goods Administration (TGA), located near Canberra, is charged with drug and device safety for Australia.
AE Reporting
The reporting of adverse events (AEs) in Australia is similar to that in other developed countries. Consumers and patients are encouraged to report AEs to a telephone hotline (1300 134 237) operated by the National Prescribing Service, a nonprofit, independent organization funded by the Australian government. Reports are forwarded to the Therapeutic Goods Administration (TGA). Alternatively, reports may be sent by mail, fax, or e-mail using the “Blue Card” (Web Resource 26-1) similar to the United Kingdom’s Yellow Card Scheme. Device information is also available at Web Resource 26-2.
Using the Blue Card, within 15 days sponsors must report all serious reaction cases for prescription drugs that are spontaneous or from company-sponsored Australian postmarketing studies (whether expected or not) that occurred in Australia. All other spontaneous cases from Australia are reported in the Periodic Safety Update Report (PSUR). Ex-Australia cases are not required to be reported unless there is a significant safety issue or action that has arisen from any analysis of foreign reports or that has been taken by a foreign regulatory agency, including the basis for such action. Such reports must be submitted within 72 hours. The TGA also requires that sponsors be able to provide promptly to the TGA clinical details of any foreign adverse drug reactions reports. For over-the-counter (OTC) drugs, the sponsor must report serious reactions that occurred in Australia within 15 days. A summary guideline is available at Web Resource 26-3, and a complete guideline at Web Resource 26-4. There is also a guideline from 2003 on postmarketing surveillance studies (Web Resource 26-5).
Clinical trial guidelines are also available based on the European Union document from 1995, at Web Resource 26-6. There are several other guidances available on all aspects of clinical trials (Web Resource 26-7).
Many European Union guidelines (including directives and regulations) have been adopted in Australia. However, there is a specific disclaimer that such guidelines when relating to prescription medicines are not so adopted (Web Resource 26-8):
Please Note: Where European Union guidelines adopted in Australia include references to European Union legislation (including EC Directives and Regulations), the requirements contained in the referenced European Union legislation are not applicable to the evaluation of prescription medicines by the TGA. The Australian legislative requirements applying to prescription medicines are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, as well as in various legislative instruments such as Therapeutic Goods Orders, Notices and Determinations, see Legislation (Web Resource 26-9).
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