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Annual performance statistics report: July 2018 to June 2019

21 October 2019

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1. Prescription medicines

Applications to register new or vary existing prescription medicines are accompanied by supportive scientific data and evaluated, with timeframes underpinned by legislation and/or associated business rules.

The framework for prescription medicines includes the following categories which are subject to legislated and/or target timeframes:

Application category Description Timeframe in working days
Category 1 An application to register a new prescription medicine (other than an additional trade name) or to make a variation to an existing medicine that involves the evaluation of clinical, pre-clinical or bio-equivalence data. For example, new chemical entities, extensions of indication and new routes of administration.

Legislated timeframe: 40 working days for notification of whether the application has passed preliminary assessment and 255 working days for the completion of the evaluation and notification of the decision.

The priority review pathway (applicable to Category 1 applications only) has the same statutory timeframe as other Category 1 applications, but the target timeframe is 150 working days.

Category 2 An application accompanied by two independent evaluation reports from comparable overseas regulators in whose jurisdiction the product is approved for the same indication. Legislated timeframe: 20 working days for notification of whether the application has passed preliminary assessment and 175 working days to notify the applicant of the decision.

Comparable Overseas Regulator (COR) report-based process

(from 1 January 2018)

An application accompanied by an un-redacted assessment report package from a comparable overseas regulator.

Legislated timeframe: 40 working days for notification of whether the application has passed preliminary assessment. The timeframe to notify the applicant of the decision depends on the COR pathway:

  • COR-A[a]: 120 working days
  • COR-B[a]: 175 working days
Category 3

An application to register or to vary the registration of a prescription medicine where the application does not require the support of clinical, pre?clinical or bio-equivalence data.

For example, broader changes to the product specifications, manufacturing and labelling or a change in trade name.

Legislated timeframe: 45 working days to notify the applicant of the decision.
Correction to, or completion of, a Register entry

An application to vary the registration of a prescription medicine to correct or complete information that was inadvertently recorded incorrectly or omitted from the Register entry.

For example, errors to product information, or quality-related documentation.

No legislated timeframe: TGA processes as soon as possible.
Safety-related request (SRR)

An application to vary the registration of a prescription medicine to either:

  • reduce the patient population that can receive the medicine or
  • add a warning or precaution.
No legislated timeframe: TGA processes as soon as possible.
Notification request to vary an ARTG entry

An application to vary the registration of a prescription medicine, where the application has been determined to pose a very low risk under certain conditions.

For example, the removal of a redundant manufacture site.

No legislated timeframe: automatic approval on submission of e-form and full payment of fee.
Self-assessable request (SAR)

An application to register or to vary the registration of a prescription medicine where the application

  • does not require the support of clinical, pre?clinical or bio-equivalence data and
  • where no data are necessary or where the data can be self-assessed by the applicant.

For example, certain changes to the pack size or approved product label.

Legislated timeframe: 45 working days for notification of acceptance or rejection of an application, completion of evaluation and notification of the decision.
Additional trade name An application for an additional trade name for a registered prescription medicine. Legislated timeframe: 45 working days.

Footnotes


1.1. Submission outcomes

Table 1 Number of completed prescription medicine submissions by type and outcome for July 2018 to June 2019
Number
Application Type Approved Withdrawn Rejected Total (% Approved)
Category 1
A: New chemical entity/New biological entity/Biosimilar 34 3 0 37 (92%)
B: New fixed-dose combination 6 0 0 6 (100%)
C: Extension of indication 50 4 2 56 (89%)
D: New generic medicine 77 8 2 87 (89%)
F: Major variation 72 2 0 74 (97%)
G: Minor variation[a] 3 0 0 3 (100%)
H: Minor variation[b] 2 0 0 2 (100%)
J: Changes to Product Information 101 0 0 101 (100%)
Comparable Overseas Regulator (COR) - A
C: Extension of indication 3 0 0 3 (100%)
Comparable Overseas Regulator (COR) - B
A: New chemical entity/New biological entity/Biosimilar 1 0 0 1 (100%)
B: New fixed-dose combination 1 0 0 1 (100%)
F: Major variation 1 0 0 1 (100%)
Minor Variations
Category 3
G: Minor variation[a] 131 3 0 134 (98%)
H: Minor variation[b] 1276 17 0 1293 (99%)
Additional trade name [ATN] 36 1 0 37 (97%)
Extension of Indications - Generic 7 0 0 7 (100%)
Safety-related request [SRR] 938 15 0 953 (98%)
Self-assessable request [SAR] 945 15 0 960 (98%)
Minor editorial change [MEC] 125 5 0 130 (96%)
Correction [9D(1)] 168 9 0 177 (95%)
Notification 1471 2 0 1473 (99.9%)
Total 5548 84 4 5536 (98%)

Footnotes


In accordance with the legislation, registered medicines must comply with numerous standards at the time they are registered and throughout their lifecycle. Following an appropriate application and review of the scientific data and safety considerations, approval may be sought to supply a product when it doesn't meet a particular standard.

Table 2 Number of other prescription medicine applications
2017-18 2018-19
July to June
Exemptions to comply with a standard [S.14] Number (% of Total)
Approved 67 (100%) 62 (98%)
Rejected 0 1 (2%)
Total (excluding withdrawals) 67 (100%) 63 (100%)
Figure 1 Submissions received 2017-18 and 2018-19 – total amount and % of total[a]
A - New chemical entity/New biological entity/Biosimilar: 2017-18 - 39 (11%); 2018-19 - 36 (10%); C - Extension of indication: 2017-18 - 58 (17%); 2018-19 - 60 (16%); D - New generic medicine: 2017-18 - 91 (27%); 2018-19 - 83 (23%).

Footnotes


Figure 1 Submissions received 2016-17 and 2017-18
Application type Jul 17 - Jun 18 Jul 18 - Jun 19
A - New chemical entity/New biological entity/Biosimilar 39 (11%) 36 (10%)
C - Extension of indication 58 (17%) 60 (16%)
D - New generic medicine 91 (27%) 83 (23%)

1.2. Approval times

Table 3 Prescription medicine application approval time for July 2018 to June 2019
Approval time (TGA working days)
Application type Legislated timeframe Mean Median Range
Category 1
A: New chemical entity/New biological entity/Biosimilar[a] 255 204 202 141 - 249
B: New fixed-dose combination 255 208 198 190 - 246
C: Extension of indication[b] 255 198 197 130 - 253
D: New generic medicine 255 181 170 96 - 254
F: Major variation 255 189 194 67 - 253
G: Minor variation 255 200 223 139 - 239
H: Minor variation 255 81 81 59 - 102
J: Changes to Product Information requiring the evaluation of data 255 134 141 4 - 249
Comparable Overseas Regulator (COR) - A
C: Extension of indication 120 50 40 36 - 74
Comparable Overseas Regulator (COR) - B
A: New chemical entity/New biological entity/Biosimilar 175 172 172 172 - 172
B: New fixed-dose combination 175 161 161 161 - 161
F: Major variation 175 146 146 146 - 146

Footnotes


Table 4 Prescription medicine median approval time comparisons
Median approval time (TGA working days)
Application type Legislated timeframe 2017-18 2018-19
(% Change)
Category 1
A: New chemical entity/New biological entity/Biosimilar[a] 255 210 202 (▼4%)
B: New fixed-dose combination 255 192 198 (▲3%)
C: Extension of indication[b] 255 194 197 (▲2%)
D: New generic medicine 255 174 170 (▼2%)
F: Major variation 255 196 194 (▼1%)
G: Minor variation 255 250 223 (▼11%)
H: Minor variation 255 164 81 (▼51%)
J: Changes to Product Information requiring the evaluation of data 255 148 141 (▼5%)
Comparable Overseas Regulator (COR) - A
C: Extension of indication 120 n/a 40
Comparable Overseas Regulator (COR) - B
A: New chemical entity/New biological entity/Biosimilar 175 n/a 172
B: New fixed-dose combination 175 n/a 161
F: Major variation 175 n/a 146
Minor Variations
Category 3
G: Minor variation[c] 45 39 40 (▲3%)
H: Minor variation[d] 45 32 36 (▲13%)
Additional trade name [ATN] 45 27 41 (▲52%)
Safety-related request [SRR] N/A 32 36 (▲9%)
Self-assessable request [SAR] 45 33 38 (▲15%)
Minor editorial change [MEC] 45 26 30 (▲15%)
Correction [9D(1)] N/A 56 56

Footnotes


Figure 2 Mean approval times for standard Category 1 submissions 2017-18 and 2018-19
A - New chemical entity: 2017-18 - 208; 2018-19 - 204; C - Extension of indication: 2017-18 - 191; 2018-19 - 198; D - New generic medicine: 2017-18 - 182; 2018-19 - 181
Figure 2 Mean approval times for standard Category 1 submissions 2017-18 and 2018-19
Application type 2017-18 data 2018-19 data
A - New chemical entity 208 204
C - Extension of indication 191 198
D - New generic medicine 182 181
Figure 3 Median approval times for standard Category 1 submissions 2017-18 and 2018-19
A - New chemical entity: 2017-18 - 210; 2018-19 - 202; C - Extension of indication: 2017-18 - 194; 2018-19 - 197; D - New generic medicine: 2017-18 - 174; 2018-19 - 170
Figure 3 Median approval times for standard Category 1 submissions 2017-18 and 2018-19
Application type 2017-18 data 2018-19 data
A - New chemical entity 210 202
C - Extension of indication 194 197
D - New generic medicine 174 170

1.3. Orphan drug destinations

The objective of the orphan drug program is to provide an incentive to sponsors to bring medicines for a small population to market and make medicines available to Australian patients who may not otherwise be able to access them. The program incentive is a 100% waiver of TGA fees for application and registration. Designation is a formal process that allows us to make a decision regarding whether a medicine is eligible for orphan drug designation. This precedes the registration application. The eligibility criteria aim is to focus the program on the greatest unmet need. A prescription medicine must have a valid orphan drug designation at the time of application to be eligible for a waiver of application and evaluation fees.

Table 5 Number of orphan drug designations
2017-18 2018-19
July to June
Number (% of Total)
Application type (proposed)
A: New chemical entity/New biological entity/Fixed dose combination 13 (81%) 16 (67%)
C: Extension of indications 2 (12%) 7 (29%)
F: Major variation 1 (6%) 1 (4%)
Total 16 (100%) 24 (100%)

Orphan drug registrations and approval times quoted in Table 6 are also included in the total number of applications reported in each respective application category in the tables and figures below.

Table 6 Number of orphan drug registrations
2017-18[a] 2018-19
July to June
Application Type Number Approved
(% of Total)
Median approval time (TGA working days) Number Approved
(% of Total)
Median approval time (TGA working days)
A: New chemical entity/New biological entity/Biosimilar 9[b] (43%) 213 8[c] (36%) 163
C: Extension of indications 10 (48%) 198 7 (32%) 212
F: Major variation 2 (9%) 185 7 (32%) 194
Total 21[b] (100%) 197 22[c] (100%) 190

Footnotes


1.4. Priority review pathway

The priority review pathway supports patient access to vital and lifesaving prescription medicines months earlier than through the standard pathway. Priority review involves the same amount and type of evidence as the standard review process. The same standards for quality, safety and efficacy apply as under the standard process. The flexible approach we take on priority applications is much more resource intensive than the standard pathway. The pathway is reserved only for medicines that represent a major therapeutic advance. The determination process is used to assess whether a medicine is eligible for the priority pathway but does not necessarily mean that the medicine will be approved after evaluation and registered on the ARTG.

Table 7 Number of priority review determinations granted
2017-18 2018-19
July - June
Number (% of Total)
Application type (proposed)
A: New chemical entity/New biological entity/Fixed dose combination 4 (29%) 6 (67%)
C: Extension of indications 10 (71%) 3 (33%)
Total 14 (100%) 9 (100%)
Table 8 Number of medicines approved through the priority review pathway[a]
2017-18 2018-19
July to June
Application Type Number Approved (% of Total) Median approval time (TGA working days) Number Approved (% of Total) Median approval time (TGA working days)
A: New chemical entity/New biological entity/Biosimilar 1 (20%) 104 3 (27%) 129
C: Extension of indications 4 (80%) 97 8 (73%) 121
Total 5 (100%) 98 11 (100%) 122

Footnotes


1.5. Provisional approval pathway

The provisional approval pathway supports patient access to vital and lifesaving prescription medicines years earlier than through the standard pathway. Time limited approval through the provisional pathway is on the basis of the evaluation of preliminary clinical data where there is the potential for a substantial benefit to Australian patients. Knowledge of the risks and benefits of these medicines is less certain than for other approved prescription medicines. Provisional approval is granted for promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.

A prescription medicine must have a valid provisional determination before it can be evaluated for registration under the provisional approval pathway. The determination process is used to assess whether a medicine is eligible for the provisional pathway but does not necessarily mean that the medicine will be approved after evaluation and provisionally registered on the ARTG.

Table 9 Number of provisional determinations granted
2017-18[a] 2018-19
July - June
Number (% of Total)
Application type (proposed)
A: New chemical entity/New biological entity/Fixed dose combination 1 (50%) 4 (44%)
C: Extension of indications 1 (50%) 5 (56%)
Total 2 (100%) 9 (100%)

Footnotes


1.6. Pathway comparison

Table 10 Number of medicines[a] approved via each pathway
2017-18 2018-19
July - June
Number (% of Total)
Pathway
Priority Review 5 (4%) 11 (7%)
Comparable Overseas Regulator (COR) - A 0 3 (2%)
Comparable Overseas Regulator (COR) - B 0 3 (2%)
Standard 115 (96%) 135 (89%)
Total 120[b][d] (100%) 152[c][d] (100%)

Footnotes


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