Introduction
The statistics provided in this half yearly performance snapshot cover the period 1 July to 31 December 2015. They provide an update on our progress and will feed into the annual Key Performance Statistics report.
To see the full comparative report use the link below.
Prescription medicines
There were a total of
878
submissions approved
Including:
19
Category 1 New Chemical Entities approved
46
Category 1 New generic medicine submissions approved
Over-the-Counter medicines
New medicine applications
102
applications approved
>99% approved within target time frames
Change
applications
530
applications approved
>96% approved within target time frames
The percentage of applications completed within target timeframes was consistently higher than the 80% target.
Mean processing times for all types of applications were below the agreed target timeframes.
Complementary medicines
14
new permitted ingredients
919
new listed medicines
2
registered medicines
14
variations to registered medicines
220
listed medicine reviews completed
Biologicals
30
Completed biological applications
Medical Devices
Conformity assessment
42
new device applications processed
100%
processed within target timeframes
Export
1063
medicine applications (export certificates)
227
medical device assessments (export certificates)
Access to unapproved therapeutic goods
Special Access Scheme
Authorised prescribers
297
authorised prescriber approvals for medicines
121
authorised prescriber approvals for medical device
Clinical trials
The TGA received 469 notifications for new clinical trials
Licencing and manufacturing
Medicines, Blood, Tissue and Cellular therapy
Domestic manufacturing licence inspections:
114
International manufacturing licence inspections:
35
Devices
International manufacturing licence inspections:
9
Domestic manufacturing licence inspections:
21
Total
Total GMP clearance applications completed:
2975
Laboratories
Between July and December 2015:
4.7 million doses of
43 different vaccine products
released in 260 shipments.
Medicine & vaccine Adverse Event Reporting
326 reports received weekly (mean)
8497 total reports received
Medical device incident reports
1969 incident reports completed
93% completed within target timeframes
Regulatory compliance
990 Products investigated for compliance issues.
525 completed regulatory compliance investigations.
Recalls
322 therapeutic goods recalled.
The full report
The illustrations and information above represent some key figures from each section of the Half Yearly Snapshot report 2015. They do not show the complete data set of the report.
To see the full comparative report use the link below.
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