TGA Office of Medicines Safety Monitoring
The TGA Office of Medicines Safety Monitoring receives reports of suspected adverse reactions to prescription medicines, vaccines, over-the-counter medicines and complementary medicines. All reports are reviewed by professional staff. Reports involving serious reactions or recently marketed drugs are reviewed by the Adverse Drug Reactions Advisory Committee (ADRAC) <http://www.tga.gov.au/adr/adrac.htm>.
The Office of Medicines Safety Monitoring has adopted performance standards with respect to the processing of reports of suspected adverse reactions:
- All reports are reviewed by professional staff within 3 working days of receipt.
- All reports are entered into the database within 2 working weeks of receipt.
Contact details
ADRAC and the TGA Office of Medicines Safety Monitoring can be contacted by:
- Email: adrac@tga.gov.au
- Phone: 1800 044 114
- Fax: 02 6232 8392