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Medicines safety

This section contains general information about the safety of medicines and how safety is monitored.

Medicines safety guidelines

• Australian pharmacovigilance requirements and recommendations for medicine sponsors
  This document sets out requirements and guidance for the reporting of adverse reactions and significant safety issues for both registered and listed medicines regulated by the TGA.
• Joint TGA-Medicines Australia guidelines for the design and conduct of company-sponsored post-marketing surveillance (PMS) studies
  These guidelines apply to company-sponsored post-marketing surveillance studies of drug safety and toxicity

Medicines safety monitoring

• Adverse events: Australian statistics on medicines
  The Office of Product Review of the Therapeutic Goods Administration, prepares reports for incorporation into the Department of Health and Ageing publication Australian Statistics on Medicines
• Therapeutic product vigilance
  TGA's approach to therapeutic product vigilance is to continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and to manage any risks associated with individual products
• Reporting medicine and vaccine adverse events
  What to report, how to report and what happens to reports of problems with medicines