You are here

Half yearly performance report - January to June 2015

16 December 2015

Book pagination

7. Exports

Processing time is defined as the number of working days from the acceptance of the application including payment until formal notification of decision. Under the Therapeutic Goods Regulations 1990, working days exclude public holidays and weekends. Processing time excludes time where the TGA was unable to progress the application until the sponsor provided additional information unless otherwise specified.

7.1 Export only medicines

The target timeframe for processing of export only medicine applications and variations is 31 working days.

Table 34: Mean approval times for export only medicines
2014 2015
Jan-Jun Jul-Dec Jan-Jun
New applications
Mean TGA processing time 24 20 21
Percentage processed within target processing time 98% 100% 100%
Variations
Mean TGA processing time 22 12 13
Percentage processed within target processing time 98% 100% 98%
Table 35: Applications for new and variations to export only medicines
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Applications received 113 112 102
Applications awaiting response from sponsor 0 6 17
Applications completed
Approved N/Aa N/Aa 100
Withdrawn N/Aa N/Aa 2
Total completed N/Aa N/Aa 102
  1. N/A - This data is not available as it was not being collected for these periods.

7.2 Export certifications for medicines

The target processing time for applications for an export certificate for a medicine is 15 working days. We aim to have 100% of applications processed within the target timeframe.

Table 36: Export certification applications and mean processing times
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Applications received 1078 1146 1044
Applications completed
Approved 1093 1155 1024
Withdrawn 0 0 4
Total completed 1093 1155 1028
Processing times
Mean TGA processing time 12 12 13
Percentage processed within target time 98% 99% 97%

7.3 Export certification assessment for medical devices

The target processing time for applications for an export certificate for a medical device is 5 working days. We aim to have at least 90% of applications processed within the target timeframe.

Table 37: Medical device applications and mean processing times for export certification assessments
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Applications received 222 239 341
Applications completed
Export certificates issued 198 255 327
Applications withdrawn 0 8 5
Total completed 198 263 332
Processing time
Mean TGA processing time 3 3 3
Percentage processed within target time 98% 95% 95%

7.4 Blood permits for export

The TGA issues permits to export human blood and its fractions (products derived from human blood) on receiving written applications from medical professionals, hospitals and bone banks. Most often these professionals or health organisations approach the Australian Red Cross who then applies for the permit on their behalf. Very rarely an individual citizen may also apply with reference to his/her requirement, for example, a patient travelling overseas with Biostate injections, which is a blood fraction and requires a permit for taking it out of Australia.

In addition to issuing individual permits, the TGA also issues annual permits. Applications for these permits are submitted by commercial (pharmaceutical companies) or government organisations (such as the Australian Defence Force). The permits cover one year's worth of anticipated export supplies for these organisations.

Figure 5: Number of blood permits processed

Number of permits processed for individual permits, blood fractions and annual permits for the periods: Jan-Jun 2014; Jul-Dec 2014 and Jan-Jun 2015.

Text version of figure 5
  • Jan-Jun 2014
    • Individual permits - 50
    • Blood fractions - 45
    • Annual permits - 27
  • Jul-Dec 2014
    • Individual permits - 27
    • Blood fractions - 60
    • Annual permits - 4
  • Jan-Jun 2015
    • Individual permits - 39
    • Blood fractions - 74
    • Annual permits - 14

Book pagination