Medicines safety monitoring

This section contains information about how the safety of medicines is monitored, and includes guidelines for sponsors and manufacturers.

Pharmacovigilance Inspection Program
Initiative to help sponsors of medicines to meet their pharmacovigilance obligations
E2B reports: frequently asked questions
The TGA has developed frequently asked questions on E2B reports for sponsors and manufacturers.
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
Note for guidance on clinical safety data management: definitions and standards for expedited reporting
Internationally accepted standard for the reporting of important clinical safety information principally arising during clinical development of medicines

Therapeutic Goods Administration (TGA)