Half Yearly Performance Report Snapshot - July to December 2015 - Infographic

Visual version, 1 July 2015-31 December 2015

26 May 2016

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.

Half yearly snapshot report - 1 July-31 December 2015.

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

 

Completed applications

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.

Half yearly snapshot report - 1 July-31 December 2015.