You are here

Annual performance statistics report: July 2018 to June 2019

21 October 2019

Book pagination

10. Medicines and biologicals manufacturing

10.1. Manufacturing licences issued to Australian manufacturers

Table 58 Status of manufacturing licence applications
2017-18 2018-19
July to June
Number (% of Total)
Licence status (Australia)[a]
New licences granted 23 (45%) 15 (47%)
Withdrawn application 5 (10%) 1 (3%)
Revoked licences - at request of licence holder 19 (37%) 13 (41%)
Revoked licences - TGA 2 (4%) 0
Suspended - at request of licence holder 2 (4%) 3 (9%)
Suspended - TGA 0 0
Total 51 (100%) 32 (100%)

Footnotes


Table 59 Outcomes of inspections of Australian manufacturers
2017-18 2018-19
July to June
Number (% of Total)
Inspection status (Australia)
Number of inspections conducted 229 195
Satisfactory compliance (of completed inspections) 179 (78%) 152 (78%)
Marginal compliance (of completed inspections) 21 (9%) 29 (15%)
Unacceptable (of completed inspections) 10 (5%) 8 (4%)
Close-out in progress 19 (8%) 6 (3%)
Processing time
Initial inspections conducted within 3 months of application 22 (96%) 16 (94%)
Re-inspections conducted within 6 months of due date 111 (73%) 112 (75%)

10.2. Approval (certification) of overseas manufacturers

Table 60 Manufacturing certification application by status (overseas)
2017-18 2018-19
July to June
Number (% of Total)
Applications (overseas)[a]
New applications received[b] 33 (38%) 36 (46%)
Re-inspection applications[b] 55 (62%) 42 (54%)
Total applications 88 (100%) 78 (100%)
Applications completed
Certified 85 (63%) 83 (56%)
Rejected[c] 51 (37%) 66 (44%)
Total completed 136 (100%) 149 (100%)

Footnotes


Table 61 Outcomes of inspections of overseas manufacturers
2017-18 2018-19
July to June
Number (% of Total)
Inspection status (overseas)
Number of inspections conducted 94 75
Satisfactory compliance (of completed inspections) 72 (77%) 64 (85%)
Marginal compliance (of completed inspections) 9 (10%) 11 (15%)
Unacceptable (of completed inspections) 3 (3%) 0 (0%)
Close-out in progress 10 (10%) 0 (0%)
Processing time
Initial certification inspections conducted within 6 months of application 15 (68%) 21 (85%)
Certification re-inspections conducted within 6 months of due date 41 (66%) 44 (85%)

10.3. Good Manufacturing Practice (GMP) clearances

GMP clearance is required by an Australian sponsor when a step in the manufacture of a medicine or an Active Pharmaceutical Ingredient is manufactured overseas and the manufacturing step is recorded on the ARTG.

Table 62 GMP clearance application status
2017-18 2018-19[a]
July to June
Number (% of Total completed)
Applications received 5327 6628
Applications completed
Approved 5041 (94%) 6252 (88%)
Rejected 344 (6%) 854 (12%)
Total completed 5385 (100%) 7106 (100%)

Footnotes


Table 63 Number of GMP Clearance applications received and completed by type from 1 July 2018 to 30 June 2019
Application Category Applications received Applications completed
Cancel 2 8
Extend 1966 2087
New 2459 2768
Reactivate 0 1
Variation 2201 2242
Table 64 Number of GMP Clearance applications actioned by pathway from 1 July 2018 to 30 June 2019
Pathway Applications received Applications completed Applications approved Applications not approved
Compliance Verification 3110 3573 3018 555
Mutual Recognition Agreement 3518 3533 3234 299

Book pagination