Adverse events increase
THE total number of medicine and vaccine adverse event reports to the Therapeutic Goods Administration (TGA) rose by 1,882 from 2016-17, representing a 9.5% increase, according to the agency’s annual performance report.
The mean number of reports received weekly rose from 380 to 416 and the proportion of reports received from each category of reporter broadly matched 2016-17.
Other elements of the TGA performance for the year 201718 include the work load around new and variation applications for biologicals, which the TGA says has stabilised back to “expected levels” following the prior period spike.
The number of new listed medicines on the Australian Register of Therapeutic Goods (ARTG) increased by 211 in 2017-18, partly attributable to the introduction of permitted indications in Mar 2018.
The number of post-market compliance reviews completed decreased in 2017-18 “due to a large and complex targeted review project of listed sunscreens having been undertaken over the course of the year”.
Investigations, which arise from complaints from the public, industry referrals and adverse event reporting, decreased.
The number of new over-thecounter medicine applications received substantially increased over the prior year, largely due to compliance with the new labelling order, while approval times for “all new medicine application types were shorter than in 2016-17”.
See the full analysis at tga.gov.au.