Monitoring the safety of therapeutic products in Australia

Pharmacovigilance

Guidelines on the reporting of adverse drug reactions by drug sponsors
<http://www.tga.gov.au/docs/html/adrguide.htm>
Describes the administrative procedures to be followed by drug sponsors in submitting Australian reports of adverse drug reactions to the TGA
Australian guideline for pharmacovigilance responsibilities of sponsors of registered medicines regulated by Drug Safety and Evaluation Branch
<http://www.tga.gov.au/adr/pharmaco.htm>
Australian pharmacovigilance guideline
Joint ADRAC-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance (PMS) studies
<http://www.tga.gov.au/adr/pmsguide.htm>
Applies to company-sponsored post-marketing surveillance studies of drug safety and toxicity
Note for guidance on clinical safety data management: definitions and standards for expedited reporting (CPMP/ICH/377/95)
<http://www.tga.gov.au/docs/html/ich37795.htm>
Internationally accepted standard for the reporting of important clinical safety information principally arising during clinical development of medicines
European Union guidelines adopted in Australia: Clinical safety guidelines
<http://www.tga.gov.au/docs/html/euguide/euad_clin.htm#clinicalsafety>

How to report a problem with a medicine
<http://www.tga.gov.au/problem/medicines.htm>

Australian medical devices guidelines - Postmarket activities
<http://www.tga.gov.au/docs/html/devguid11.htm>
Describes the obligations and responsibilities of sponsors and manufacturers of medical devices after medical devices have been approved for supply in Australia
Samples for testing - Protocol for sending medical devices to the TGA for testing
<http://www.tga.gov.au/problem/iris/devices-testing.htm>
Medical devices involved in an adverse event may be sent to the TGA for testing