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Half yearly performance report - January to June 2015

16 December 2015

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2. Over-the-Counter medicines

Over-the-Counter (OTC) medicines applications are categorised as new medicine (N) or change (C) applications and are further categorised by risk (N1 and C1 are low risk, N5 and C4 are highest risk). The OTC application categorisation framework outlined below defines the different OTC medicine application levels and the key application criteria.

Table 5: Categorisation of OTC medicines applications
Application category Definition
N1 An application submitted as a 'Clone'.
N2 An application which complies with an over-the-counter medicine monograph.
N3 New application for a 'generic' medicine other than those 'generic' applications in levels N1, N2 or N4.
N4

An application for a 'generic' medicine where the medicine:

is included in Appendix X (but which is not a level N1 application) and/or

includes an umbrella branded product name where the umbrella segment is categorised as requiring a higher level of assessment and/or

requires supporting safety and/or efficacy (clinical/toxicological) data or a justification for not providing such data.

N5 An application for a new product that is an extension to a 'generic category' product or an application for a product containing a new chemical entity as an active ingredient.
C1 Quality and non-quality changes.
C2 Quality changes or non-quality changes - no safety and efficacy data required.
C3 Umbrella branding - higher level of assessment or non-quality changes - safety and efficacy data may be required.
C4 Non-quality changes - data are required.

2.1 Approval times

Approval time is defined as the number of working days from the acceptance of the application until formal notification of decision. Approval time excludes time where the TGA was unable to progress the application until the sponsor provided additional information unless otherwise specified.

We aim to have 80% of applications completed within target timeframes. Target timeframes for processing of applications are a result of new OTC pre-market business processes and are subject to ongoing review.

Table 6: Mean approval time for OTC medicine applications
2014 2015
Jan-Jun Jul-Dec Jan-Jun

New medicine applications

N1 21 30 23
N2 49 29 31
N3 97 51 66
N4 105 125 64
N5 N/Aa 123 75

Change applications

C1 16 8 12
C2 40 16 19
C3 33 84 47
C4 69 0 44
  1. The one N5 application processed to a decision in January to June 2014 was submitted prior to implementation of the new business process.
Table 7: OTC medicine approval time against target time by application category for January to June 2015
Application type Number completed Range Mean Median Target time % within target
New medicines
N1 56 6-44 23 21 45 100
N2 1 N/A 31 31 75 100
N3 8 19-121 66 52 150 100
N4 10 29-106 64 59 170 100
N5 3 70-80 75 74 210 100
Change applications
C1 265 2-41 12 11 20 91
C2 126 0-64 19 11 64 100
C3 2 15-79 47 47 120 100
C4 5 44 44 44 170 100
Total 476
Table 8: Percentage of OTC medicine applications processed within target time
2014 2015
Jan-Jun Jul-Dec Jan-Jun
New medicine applications (%)
N1 98 94 100
N2 100 100 100
N3 100 100 100
N4 100 100 100
N5 N/Aa 100 100
Change applications (%)
C1 84 96 91
C2 98 99 100
C3 100 67 100
C4 100 N/Ab 100
  1. The one N5 application processed to a decision in January to June 2014 was submitted prior to implementation of the new business process.
  2. There were no C4 applications finalised in this period.

2.2 Applications

2.2.1 New OTC medicine applications

Table 9: Applications received for new OTC medicines and changes to existing medicines
2014 2015
Jan-Jun Jul-Dec Jan-Jun
New medicine applications
N1 138 88 56
N2 0 8 1
N3 18 21 28
N4 13 45 13
N5 5 8 6
Total 174 170 104
Change applications
C1 183 255 290
C2 129 125 136
C3 8 2 2
C4 0 11 6
Total 320 393 434

2.2.2 Completed applications

Table 10: New OTC medicine applications completed and outcomes
2014 2015
Jan-Jun Jul-Dec Jan-Jun
N1
Approved 131 106 56
Rejected 0 0 0
Withdrawn by sponsor 5 9 0
Returned/failed screening 0 1 0
Total 136 116 56
N2
Approved 2 8 1
Rejected 0 0 0
Withdrawn by sponsor 0 0 0
Returned/failed screening 0 0 0
Total 2 8 1
N3
Approved 38 19 8
Rejected 0 0 0
Withdrawn by sponsor 1 0 1
Returned/failed screening 2 2 7
Total 41 21 16
N4
Approved 17 46 10
Rejected 1 0 0
Withdrawn by sponsor 0 5 1
Returned/failed screening 6 7 4
Total 24 58 15
N5
Approved 1 12 3
Rejected 0 0 0
Withdrawn by sponsor 2 0 0
Returned/failed screening 2 5 4
Total 5 17 7
Table 11: OTC change applications completed and outcomes
2014 2015
Jan-Jun Jul-Dec Jan-Jun
C1
Approved 184 257 265
Rejected 0 0 0
Withdrawn by sponsor 7 4 3
Returned/failed screening 0 0 0
Total 191 261 268
C2
Approved 169 129 126
Rejected 0 0 0
Withdrawn by sponsor 1 4 6
Returned/failed screening 0 1 4
Total 170 134 136
C3
Approved 6 3 2
Rejected 0 0 0
Withdrawn by sponsor 0 0 0
Returned/failed screening 0 0 0
Total 6 3 2
C4
Approved 3 0 5
Rejected 0 0 0
Withdrawn by sponsor 0 0 0
Returned/failed screening 0 0 0
Total 3 0 5

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