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Annual performance statistics report: July 2016 to June 2017

12 September 2017

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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 we were 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 39 Approval times for export only medicines
  2015-16 2016-17
July to June
New applications
Mean TGA processing time (days) 21 25
Median TGA processing time (days) 20 26
Percentage processed within target processing time 98% 75%
Variations
Mean TGA processing time (days) 18 22
Median TGA processing time (days) 16 22
Percentage processed within target processing time 100% 89%
Table 40 Applications for new and variations to export only medicines
  2015-16 2016-17
July to June
Export only applications
Applications received 241 242
Applications awaiting response from sponsor 20 9
Applications completed
Approved 221 207
Withdrawn 10 17
Total completed 231 224

7.2. Export certifications for medicines

The target processing time for applications for an export certificate for a medicine is 15 working days.

Table 41 Export certification applications and processing times
  2015-16 2016-17
July to June
Applications received 2,124 1,582
Applications completed
Approved 2,127 1,413
Withdrawn 18 3
Total completed 2,145 1,416
Processing times
Mean TGA processing time (days) 12 12
Median TGA processing time (days) 12 13
Percentage processed within target timea 98% 99%
  1. We aim to have 100% of applications processed within the target timeframe.

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.

Table 42 Medical device applications and processing times for export certification assessments
  2015-16 2016-17
July to June
Applications received 496 553
Applications completed
Export certificates issued 483 504
Applications withdrawn 3 10
Total completed 486 514
Processing time
Mean TGA processing time (days) 4 4.5
Median TGA processing time (days) 5 4
Percentage processed within target timea 96% 83%
  1. We aim to have at least 90% of applications processed within the target timeframe.

7.4. Blood permits for export

We issue 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 Blood Service which 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 to take 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 7 Number of blood permits processed

Jul 15 - Jun 16: Bone and Tissues 50, Blood and fractions 144, Annual blood permits 33; Jul 16 - Jun 17: Bone and Tissues 46, Blood and fractions 104, Annual blood permits 46
Figure 7 Number of blood permits processed
Permit type Jul 15 - Jun 16 Jul 16 - Jun 17
Bone and tissues 50 46
Blood and fractions 144 104
Annual blood permits 33 46

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