VERIFIED compliance breaches for over the counter and complementary medicines were reported at a staggering 80% for 2015-16 compared with an equally alarming 73% for 2014-15, in the latest Performance Statistics Report, the Therapeutic Goods Administration (TGA) report card.
Labelling, advertising and evidence continued to be the major compliance breaches for listed medicines, with the TGA targeting "safety-related issues" and the results in spite of a "significant increase in compliance reviews".
Key performance indicators for the TGA were the focus of the report revealing some improvements of approval times for prescription medicines but a significant increase in approval times for new generic medicines.
There was a significant increase in applications received for variations to approved biologicals and an increase in the number of Special Access Scheme Category B applications for biologicals in 2015-16, due to an increase in applications by dental practitioners for access to a new bone graft item.
Medicine and vaccine adverse events reports in 2015-16 were similar to those in 2014-15, while reports from pharmacists declined, reflecting a change to pharmacist reporting classifications during reporting periods.
Adverse event reporting from members of the public increased, probably as a result of promotion around adverse event reporting.
Device incident increases may have been due to the 'inSite' program and increased vigilance within the medical community the report said.
For full details see tga.gov.au.
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