And adverse event reporting increased by more than 2,000 notifications, according to TGA’s latest stats
Key observations for 2016-17 compared with 2015-16, provided by the TGA are as follows:
1. The number of new ingredients approved for use in listed medicines significantly increased to 79 in 2016-17, compared with 18 in 2015-16.
2. Adverse event reporting increased by more than 2,000 notifications, from 17,633 medicine and vaccine adverse event notifications in 2015-16 to 19,736 in 2016-17.
The increased number of vaccine Adverse Event Reports may reflect recent additions to the National Immunisation Program in 2016, suggests the TGA.
Adverse event reporting from members of the public also increased, which is likely to be the result of activity to promote consumer adverse event reporting.
3. There was a significant decrease in the number of medicine recalls from 57 in 2015-16 to 32 in 2016-17, and a slight decrease from 611 in 2015-16 to 598 in 2016-17 in the number of medical device recalls.
4. The number of approved new registered complementary medicines increased to 10 in 2016-17 compared with three in 2015-16.
“Registered complementary medicines are considered to be of relatively higher risk than listed medicines based on their ingredients or the indications for the medicine,” says the TGA.
“These medicines are fully evaluated by us for quality, safety and efficacy prior to being accepted on the ARTG.”
5. The number of new OTC medicine applications received increased, particularly the number of low- and medium-risk applications.
6. The number of notifications and applications for most Special Access Scheme (SAS) categories increased since 2015-16.
7. There was a substantial decrease in the number of applications received to vary existing medicines.
8. Number of Extension of Indication submissions for prescription medicines increased noticeably.
9. Meanwhile, the number of generic medicine submissions greatly decreased.
10. Investigations, which arise from complaints from the public, industry referrals and adverse event reporting, increased in 2016-17 compared with 2015-16. The rate of verified compliance breaches has remained similar; 79% in 2016-17 compared with 80% in 2015-16.
“This suggests that the significant increase in the number of compliance reviews in recent years has not driven any improvement in compliance rates,” says the TGA. Labelling, advertising and evidence continued to be major compliance breaches for listed medicines.
11. Investigations into regulatory compliance matters increased by 64% in 2016-17, with 2,887 completed compared with 1,760 in 2015-16. The largest contributor to investigations continues to be referrals from Australian Border Force in relation to the importation of unapproved prescription medicines.
12. The number of new and variation applications stabilised following the transition of most biologicals
into the new biologicals regulatory framework during 2014-15