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
Product types