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Half yearly performance report - January to June 2015

16 December 2015

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1. Prescription medicines

Applications to register new, or vary existing, prescription medicines are accompanied by supportive scientific data and evaluated appropriately; 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.
  • Examples of Category 1 applications include 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: Differs from a Category 1 application in that it is 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.
  • Examples of Category 3 applications include 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 approval times for January to June 2015
Approval time
Application type Legislated timeframe Mean Median Minimum Maximum
A: New chemical entity
Category 1 255 200 206 88 251
B: New fixed-dose combination
Category 1 255 183 189 133 239
C: Extension of indication
Category 1 255 192 206 40 240
D: New generic medicine
Category 1 255 177 169 127 253
E: Additional trade name
Category 1 255a 190 196 111 285
F: Major variationb
Category 1 255 188 189 126 244
G: Minor variationc
Category 1 255 0 0 0 0
Category 3 45 17 17 6 37
H: Minor variationd
Category 1 255 131 101 56 237
Category 3 45 22 18 1 106
J: Changes to product information requiring the evaluation of data
Category 1 255 152 162 18 245
  1. In July 2015, a new process with a new legislative timeframe was introduced for additional trade name submissions. During the reporting period relevant to this report, these applications were under the Category 1 framework and a legislated timeframe of 255 working days applied.
  2. During this reporting period, the TGA also approved one Category 2 application (F: Major variation) in 151 working days.
  3. The type G minor variations differ from type H minor variations in that they result in a new ARTG entry.
  4. The minor variations (type H) included in the table above 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.

1.2 Submission outcomes

Table 2: Number of completed prescription medicine submissions by type and outcome for January to June 2015
Submission Type Approved Withdrawn Rejected Total
A: New chemical entity 16 1 1 18
B: New fixed-dose combination 7 0 0 7
C: Extension of indication 21 0 0 21
D: New generic medicine 56 6 0 62
E: Additional trade name 15 1 0 16
F: Major variation 21 2 0 23
G: Minor variation 70 0 0 70
H: Minor variation (Category 1) 3 0 0 3
H: Minor variation (Category 3) 652 3 1 656
J: Changes to Product Information 39 4 0 43
Total 900 17 2 919

1.3 Other applications

In addition to the application types discussed above, the TGA also processes 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 such applications is presented below.

In accordance with the legislation, registered goods 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, the TGA may grant an 'exemption' from a particular standard for a product. The number of such applications approved and rejected is also included in the following table.

Table 3: Number of other Prescription Medicine applications
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Safety related request 358 360 390
Self-assessable request 582 608 621
Minor editorial change to product information 264 272 281
Correction of error 98 94 69
Total 1302 1334 1361
Exemptions to comply with a standard
Approved N/Aa N/Aa 34
Rejected N/Aa N/Aa 0
Total N/Aa N/Aa 34
  1. N/A - This data is not available as it was not being collected for these periods.

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 Australian Register of Therapeutic Goods (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 4: Number of orphan drug designations
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Number of designations 11 11 9

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