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Annual performance statistics report: July 2016 to June 2017

12 September 2017

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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 timeframes:

  • Category 1 application: 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.

    The legislated timeframes for the two stages of a Category 1 application are: 40 working days for notification of acceptance or rejection of the application and 255 working days for the completion of the evaluation and notification of the decision.

  • Category 2 application: An application accompanied by two independent evaluation reports from comparable overseas regulators in whose jurisdiction the product is approved for the same indication.

    The legislated timeframes for the two stages of a Category 2 application are: 20 working days for notification of acceptance or rejection of an application and 175 working days to notify the applicant of the decision.

  • Category 3 application: 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, a change in the site of manufacture, a change to the synthetic route, a change in the product specifications, a change in the steps of manufacture or a change in trade name.

    The legislated timeframe for a Category 3 application is 45 working days for notification of acceptance or rejection of an application, completion of evaluation and notification of the decision.

1.1. Approval times

Once an application has been accepted by the TGA, the approval time is defined as the number of TGA working days until a decision is made. As detailed above, this timeframe is underpinned by legislation and excludes public holidays, weekends, the time allocated to the applicant to provide responses to requests for information and 'mutual clock stop' periods agreed with the applicant.

In accordance with the Therapeutic Goods Regulations 1990, a 'submission' may include a number of applications submitted at the one time. The data presented below relates to submissions as this best reflects the evaluation and decision-making processes.

Table 1 Prescription medicine application approval time for July 2016 to June 2017
  Approval time (TGA working days)
Application type Submissions approved Legislated timeframe Mean Median Range
A: New chemical entity
Category 1 38 255 220 208 161-238
B: New fixed-dose combination
Category 1 4 255 201 203 179-218
C: Extension of indication
Category 1 45 255 198 202 106-238
D: New generic medicine
Category 1 111 255 182 172 109-254
E: Additional trade name (ATN)
Category 1 2 255 140 140 44-237
ATN 47 45 34 36 10-62
F: Major variation
Category 1 46 255 185 185 134-226
G: Minor variation
Category 1 0 255 N/A N/A N/A
Category 3 104 45 27 26 8-43
H: Minor variation
Category 1 4 255 142 143 111-172
Category 3 1,253 45 24 23 1-51
J: Changes to Product Information requiring the evaluation of data
Category 1 63 255 142 140 46-228
Table 2 Prescription medicine median approval time comparisons
  Median approval time (TGA working days)
Application type Legislated timeframe 2015-16 2016-17
A: New chemical entity
Category 1 255 199 208
B: New fixed-dose combination
Category 1 255 167 203
C: Extension of indication
Category 1 255 195 202
D: New generic medicine
Category 1 255 158 172
E: Additional trade name (ATN)a
Category 1 255 219 140
ATN 45 35 36
F: Major variation
Category 1 255 183 185
G: Minor variationb
Category 1 255 163 0 b
Category 3 45 19 26
H: Minor variationc
Category 1 255 146 143
Category 3 45 20 23
J: Changes to Product Information requiring the evaluation of data
Category 1 255 134 140
  1. In July 2015, a legislated 45 working day process for ATN submissions commenced. These applications were under both the Category 1 framework with a legislated timeframe of 255 working days and the new ATN submission framework with a legislated timeframe of 45 working days.
  2. The type G minor variations differ from type H minor variations in that they result in a new ARTG entry. No type G Category 1 applications were approved in 2016-17.
  3. The minor variations (type H) refer to applications to change the formulation, composition or design specification or the container for the goods or any other attribute that results in the goods being separate and distinct. These applications are typically 'Category 3' changes, unless the supporting scientific package contains non-clinical or clinical data in which case the application is a 'Category 1' application.

Figure 1 Submissions received 2015-16 to 2016-17

Jul 15 - Jun 16: New Chemical Entity 43, Extension of Indication 46, New Generic Medicine 142; Jul 16 - Jun 17: New Chemical Entity 43, Extension of Indication 56, New Generic Medicine 100
Figure 1 Submissions received 2015-16 to 2016-17
Application type Jul 15 - Jun 16 Jul 16 - Jun 17
New chemical entity 43 43
Extension of indication 46 56
New generic medicine 142 100

Figure 2 Mean approval times 2015-16 to 2016-17

Jul 15 - Jun 16: New Chemical Entity 193, Extension of Indication 186, New Generic Medicine 170; Jul 16 - Jun 17: New Chemical Entity 220, Extension of Indication 198, New Generic Medicine 182
Figure 2 Mean approval times 2015-16 to 2016-17
Application type Jul 15 - Jun 16 Jul 16 - Jun 17
New chemical entity 193 220
Extension of indication 186 198
New generic medicine 170 182

Figure 3 Median approval times 2015-16 to 2016-17

Jul 15 - Jun 16: New Chemical Entity 199, Extension of Indication 195, New Generic Medicine 158; Jul 16 - Jun 17: New Chemical Entity 208, Extension of Indication 202, New Generic Medicine 172
Figure 3 Median approval times 2015-16 to 2016-17
Application type Jul 15 - Jun 16 Jul 16 - Jun 17
New chemical entity 199 208
Extension of indication 195 202
New generic medicine 158 172

1.2. Submission outcomes

Table 3 Number of completed prescription medicine submissions by type and outcome for July 2016 to June 2017
Submission Type Approved Withdrawn Rejected Total
A: New chemical entity 38 4 0 42
B: New fixed-dose combination 4 2 0 6
C: Extension of indication 45 2 2 49
D: New generic medicine 111 2 2 115
E: Additional trade name (ATN) (Category 1) 2 0 0 2
E: ATN 47 1 0 48
F: Major variation 46 2 1 49
G: Minor variation 104 2 0 106
H: Minor variation (Category 1) 4 0 0 4
H: Minor variation (Category 3) 1,253 16 0 1,269
J: Changes to Product Information 63 3 0 66
Total 1,717 34 5 1,756

1.3. Other applications

In addition to the application types discussed above, we also process numerous other application types. These applications are assessed in accordance with a risk-based approach, for example, some requests are categorised as 'self-assessable' and do not usually involve the evaluation of scientific data. Some applications are received because the sponsors are obliged to inform the TGA of new information related to the safety of their products. Other applications involve editorial corrections to the register entry or the associated product information document. The number of these applications is presented below.

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, we may grant an 'exemption' from a particular standard for a product. The number of applications approved and rejected is also presented below.

Table 4 Number of other prescription medicine applications
  2015-16 2016-17
July to June
Prescription medicine applications
Safety related request 781 738
Self-assessable request 1,404 1,244
Minor editorial change to product information 481 459
Correction of error 123 124
Total 2,789 2,565
Exemptions to comply with a standard
Approved 88 89
Rejected 0 1
Total 88 90

1.4. Orphan drug designations

'Orphan drugs' are often developed to treat small and very specific patient populations who suffer from rare diseases and conditions. The application and evaluation fees for orphan drugs can be waived to help reduce their development costs and facilitate their access to the Australian marketplace. A medicine needs to be designated by the TGA as an orphan drug before an application can be accepted to register it on the ARTG. The designation process involves a review of whether the drug meets the established criteria which are underpinned by legislation.

The quality, efficacy and safety of orphan drugs are assessed at the same standard as for other registered prescription medicines.

Table 5 Number of orphan drug designations
  2015-16 2016-17
July to June
Number of designations 22 29

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