TGA tightens pharmacovigilance rules
The new document, which has also undergone a name change to the Australian Requirements and Recommendations for Pharmacovigilance Responsibilities of Sponsors of Medicines, has been amended to clearly differentiate between mandatory reporting requirements and information provided as a guide for sponsors.
On its website the TGA said while there were no changes to reporting requirements for sponsors of prescription medicines, “sponsors of other medicines on the Australian Register of Therapeutic Goods (ARTG) are now expected to routinely report serious adverse reactions within 15 calendar days, as opposed to all adverse reactions or similar experiences as soon as practicable”.
Another stricter requirement is the reporting of “significant safety issues” in writing to the Office of Product Review in less than 72 hours.
The revised pharmacovigilance document came into effect on 10 November this year, having