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Annual performance statistics report: July 2016 to June 2017

12 September 2017

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2. Over-the-Counter medicines

Over-the-Counter (OTC) medicine 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 6 Categorisation of OTC medicine applications
Application category Definition
N1 An application submitted as a 'Clone'.
N2 An application which complies with an OTC 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:

  • requires supporting safety and/or efficacy (clinical/toxicological) data or a justification for not providing such data; and/or
  • requires a higher level of assessment due to the umbrella branding segment of the product name; and/or
  • has not been previously registered as an OTC medicine following down-scheduling.
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 classified as 'negligible risk'.
C2 Quality and non-quality changes classified as 'low risk' ' no safety and/or efficacy data required; quality data may be required.
C3

Quality and non-quality changes classified as 'low risk' ' safety and/or efficacy data required unless justified; quality data may be required.

Umbrella branding segment of new name requires a higher level of assessment.

C4 Non-quality changes classified as 'moderate risk' ' safety and/or efficacy data required unless justified.
B1 Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that does not contain clinical data.
B3 Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that contains clinical data or a justification as to why such data is not needed.
Requests for consent under section 14/14A of the Act Request for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard.

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 we were 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 7 Median approval time for OTC medicine applications
  2015-16 2016-17
July to June
New medicine applications (days)
N1 14 27
N2 26 43
N3 90 94
N4 89 106
N5 151 192
Change applications (days)
C1 5 7
C2 8 14
C3 31 14
C4 110 86
Table 8 OTC medicine approval time against target time by application category for July 2016 to June 2017
Application type Number completed Range Mean Median Target time (days) % within target
New medicines
N1 93 0-41 25 27 45 100
N2 7 37-47 42 43 55 100
N3 29 16-143 88 94 150 100
N4 29 4-162 101 106 170 100
N5 8 45-196 167 192 210 100
Change applications
C1 396 0-75 8 7 20 97
C2 226 0-78 21 14 64 99.6
C3 7 10-107 30 14 120 100
C4 1 86 86 86 170 100
Table 9 Percentage of OTC medicine applications processed within target time
  2015-16 2016-17
July to June
New medicine applications (%)
N1 100 100
N2 100 100
N3 100 100
N4 100 100
N5 83a 100
Change applications (%)
C1 97 97
C2 99 99.6
C3 100 100
C4 100 100
  1. Of the six N5 applications completed in 2015-16, one was not completed within the target timeframe. This application required referral to the Advisory Committee on Non-prescription Medicines (ACNM), which typically extends the evaluation process by 3-6 months.

2.2. Applications

2.2.1 New OTC medicine applications

Table 10 Applications received for new OTC medicines and changes to existing medicines
  2015-16 2016-17
July to June
New medicine applications
N1 75 108
N2 13 5
N3 30 44
N4 45 23
N5 14 6
Total 177 186
Change applications
C1 632 387
C2 312 276
C3 8 7
C4 1 2
Total 953 672

2.2.2 Completed applications

Table 11 New OTC medicine applications completed and outcomes
  2015-16 2016-17
July to June
N1
Approved 79 93
Rejected 0 0
Withdrawn by sponsor 0 1
Returned/failed screening 1 0
Total 80 94
N2
Approved 3 7
Rejected 0 0
Withdrawn by sponsor 0 1
Returned/failed screening 5 0
Total 8 8
N3
Approved 25 29
Rejected 0 0
Withdrawn by sponsor 7 2
Returned/failed screening 7 3
Total 39 34
N4
Approved 50 29
Rejected 0 0
Withdrawn by sponsor 0 0
Returned/failed screening 5 6
Total 55 35
N5
Approved 6 8
Rejected 0 0
Withdrawn by sponsor 1 0
Returned/failed screening 5 0
Total 12 8
Table 12 OTC change applications completed and outcomes
  2015-16 2016-17
July to June
C1
Approved 618 396
Rejected 0 0
Withdrawn by sponsor 15 10
Returned/failed screening 0 0
Total 633 406
C2
Approved 309 226
Rejected 0 0
Withdrawn by sponsor 3 7
Returned/failed screening 0 1
Total 312 234
C3
Approved 4 7
Rejected 0 0
Withdrawn by sponsor 0 1
Returned/failed screening 0 2
Total 4 10
C4
Approved 12 1
Rejected 0 0
Withdrawn by sponsor 0 0
Returned/failed screening 0 0
Total 12 1

2.2.3 Other applications

In addition to the application types discussed above, we also process other application types. This includes requests for advice for the purpose of listing a medicine as a pharmaceutical benefit. The number of requests 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, we may grant an 'exemption from a particular standard for a product. The number of applications approved and rejected is also presented below.

Table 13 Number of other OTC medicine applications
  2015-16 2016-17
July to June
Requests for advice for the purpose of listing a medicine as a pharmaceutical benefita
B1 N/A 1
B3 N/A 1
Total N/A 2
Requests for consent under section 14/14A of the Act to import, export or supply therapeutic goods not complying with an applicable standardb
Approved N/A 25
Rejected N/A 1
Total N/A 26
  1. B1 and B3 requests have recently been implemented. This is the first year for reporting on these application types. Both B1 and B3 applications were approved.
  2. Reporting of requests under section 14/14A of the Act has been introduced in this reporting period.

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