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Annual performance statistics report: July 2016 to June 2017

12 September 2017

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9. Medicines and biologicals manufacturing

9.1. Manufacturing licences issued to Australian manufacturers

Table 51 Status of manufacturing licence applications
  2015-16 2016-17
July to June
Licence status (Australia)
New licences granted 15 9
Withdrawn application 11 10
Revoked licences - at request of licence holder 42 19
Revoked licences - TGA 0 1
Suspended - at request of licence holder 3 1
Suspended - TGA 0 0

As at 30 June 2017, there were 247 Australian companies holding manufacturing licences covering 387 sites.

Table 52 Outcomes of inspections of Australian manufacturers
  2015-16 2016-17
July to June
Inspection status (Australia)
Number of inspections conducted 220 185
Satisfactory compliance (of completed inspections) 81% 88%
Marginal compliance (of completed inspections) 18% 10%
Unacceptable (of completed inspections) 1% 2%
Close-out in progress 15% 18%
Processing time
Initial inspections conducted within 3 months of application 68% 85%
Re-inspections conducted within 6 months of due date 54% 61%

The 2016-17 data excludes inspections conducted for Australian medical devices manufacturers. This information is now reported under medical devices as Quality Management System (QMS) audits of Australian manufacturers.

The number of initial inspections conducted within 3 months of application improved in 2016-17 due to improved internal processes and focused efforts on ensuring initial inspections were conducted in a timely manner.

9.2. Approval (certification) of overseas manufacturers

Table 53 Manufacturing certification application by status (overseas)
  2015-16 2016-17
July to June
Applications (overseas)
New applications received 38 46
Re-inspection applications 52 38
Applications completed
Certified 44 33
Rejected 28 59
Total completed 72 92

As at 30 June 2017, there were 206 overseas manufacturers covering 207 manufacturing sites that were subject to TGA inspection and approximately 2,700 overseas manufacturing sites that relied on evidence from recognised regulators.

Table 54 Outcomes of inspections of overseas manufacturers
  2015-16 2016-17
July to June
Inspection status (overseas)
Number of inspections conducted 76 58
Satisfactory compliance (of completed inspections) 95% 94%
Marginal compliance (of completed inspections) 4% 6%
Unacceptable (of completed inspections) 1% 0%
Close-out in progress 18% 10%
Processing time
Initial certification inspections conducted within 6 months of application 40% 64%
Certification re-inspections conducted within 6 months of due date 75% 66%

The 2016-17 data excludes inspections conducted for overseas medical devices manufacturers. This information is now reported under medical devices as QMS audits of overseas manufacturers.

The number of initial overseas inspections conducted within six months of application improved in 2016-17 due to improved internal processes and focused efforts on ensuring initial inspections were conducted in a timely manner.

9.3. Good Manufacturing Practice clearances

GMP clearance is required for all medicines (unless exempt) supplied in Australia. This includes products supplied to sponsors by overseas manufacturers.

Table 55 GMP clearance application status
  2015-16 2016-17
July to June
Applications received 5,657 6,506
Applications completed
Approved 5,132 5,067
Rejected 263 642
Total completed 5,395 5,709

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