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Annual performance statistics report: July 2018 to June 2019
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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 on the following page defines the different OTC medicine application levels and the key application criteria.
| Application category | Definition | Timeframe in days |
|---|---|---|
| N1 | An application submitted as a 'clone'. | 45 working days |
| N2 | An application which complies with an OTC medicine monograph. | 55 working days |
| N3 | New application for a 'generic' medicine other than those 'generic' applications in levels N1, N2 or N4. | 150 working days |
| N4 |
An application for a 'generic' medicine where the medicine:
|
170 working days |
| 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. | 210 working days |
| CN |
'Notification' changes, where their implementation would not impact the quality, safety or efficacy of a medicine. Includes quality and non-quality changes classified as 'negligible risk'. - Implemented 1 July 2017 |
N/A (Automated validation and approval) |
| C1 | Quality and non-quality changes classified as 'negligible risk'. | 20 working days |
| C2 | Quality and non-quality changes classified as 'low risk' - no safety and/or efficacy data required; quality data may be required. | 64 working days |
| 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. |
120 working days |
| C4 | Non-quality changes classified as 'moderate risk' - safety and/or efficacy data required unless justified. | 170 working days |
| 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. | 20 working days |
| 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. | 120 working days |
| 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. | N/A |
2.1. Approval times
We aim to have 80% of applications completed within target timeframes. The following target timeframes apply to OTC medicine applications:
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| New medicine applications (days) | ||
| N1 | 25 | 30 |
| N2 | 35 | 48 |
| N3 | 74 | 95 |
| N4 | 55 | 97 |
| N5 | 162 | 121 |
| Change applications (days) | ||
| C1 | 4 | 4.5 |
| C2 | 31 | 36 |
| C3 | 72 | 84 |
| C4 | 95 | 109 |
| Application type | Number completed (% of Total) | Range | Mean | Median | % within target |
|---|---|---|---|---|---|
| New medicines | |||||
| N1 | 129 (58%) | 0-66 | 29 | 30 | 87 |
| N2 | 18 (8%) | 28-55 | 45 | 48 | 100 |
| N3 | 52 (24%) | 8-188 | 92 | 95 | 94 |
| N4 | 13 (6%) | 18-217 | 101 | 97 | 85 |
| N5 | 9 (4%) | 81-198 | 126 | 121 | 100 |
| Total | 221 (100%) | ||||
| Change applications | |||||
| C1 | 182 (25%) | 0-88 | 7 | 4.5 | 96 |
| C2 | 549 (74%) | 0-121 | 37 | 36 | 89 |
| C3 | 8 (1%) | 33-214 | 87 | 84 | 88 |
| C4 | 2 (0.2%) | 82-136 | 109 | 109 | 100 |
| Total | 741 (100%) | ||||
2.2. Applications
2.2.1 New OTC medicine applications
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Number (% of Total) | ||
| New medicine applications | ||
| N1 | 169 (60%) | 100 (40%) |
| N2 | 16 (6%) | 18 (7%) |
| N3 | 64 (23%) | 70 (28%) |
| N4 | 23 (8%) | 39 (16%) |
| N5 | 8 (3%) | 23 (9%) |
| Total | 280 (100%) | 250 (100%) |
| Change applications | ||
| CN | 171 (21%) | 197 (18%) |
| C1 | 190 (24%) | 197 (18%) |
| C2 | 438 (54%) | 675 (62%) |
| C3 | 7 (0.8%) | 7 (0.6%) |
| C4 | 3 (0.4%) | 6 (0.6%) |
| Total | 809 (100%) | 1082 (100%) |
2.2.2 Completed applications
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Number (% of Total) | ||
| N1 | ||
| Approved | 144 (96%) | 129 (98%) |
| Rejected | 0 | 0 |
| Withdrawn by sponsor | 7 (4%) | 3 (2%) |
| Returned/failed screening | 0 | 0 |
| Total | 151 (100%) | 132 (100%) |
| N2 | ||
| Approved | 5 (45%) | 18 (82%) |
| Rejected | 0 | 0 |
| Withdrawn by sponsor | 6 (55%) | 4 (18%) |
| Returned/failed screening | 0 | 0 |
| Total | 11 (100%) | 22 (100%) |
| N3 | ||
| Approved | 37 (81%) | 52 (81%) |
| Rejected | 0 | 0 |
| Withdrawn by sponsor | 1 (2%) | 0 |
| Returned/failed screening | 8 (17%) | 12 (19%) |
| Total | 46 (100%) | 64 (100%) |
| N4 | ||
| Approved | 19 (76%) | 13 (65%) |
| Rejected | 1 (4%) | 0 |
| Withdrawn by sponsor | 3 (12%) | 3 (15%) |
| Returned/failed screening | 2 (8%) | 4 (20%) |
| Total | 25 (100%) | 20 (100%) |
| N5 | ||
| Approved | 8 (73%) | 9 (90%) |
| Rejected | 0 | 0 |
| Withdrawn by sponsor | 2 (18%) | 0 |
| Returned/failed screening | 1 (9%) | 1 (10%) |
| Total | 11 (100%) | 10 (100%) |
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Number (% of Total) | ||
| C1 | ||
| Approved | 202 (99%) | 182 (97%) |
| Rejected | 0 | 0 |
| Withdrawn by sponsor | 2 (1%) | 6 (3%) |
| Returned/failed screening | 0 | 0 |
| Total | 204 (100%) | 188 (100%) |
| C2 | ||
| Approved | 386 (97%) | 549 (99%) |
| Rejected | 0 | 0 |
| Withdrawn by sponsor | 11 (3%) | 7 (1%) |
| Returned/failed screening | 2 (0.5%) | 0 |
| Total | 399 (100%) | 556 (100%) |
| C3 | ||
| Approved | 5 (83%) | 8 (80%) |
| Rejected | 0 | 0 |
| Withdrawn by sponsor | 0 | 1 (10%) |
| Returned/failed screening | 1 (17%) | 1 (10%) |
| Total | 6 (100%) | 10 (100%) |
| C4 | ||
| Approved | 4 (100%) | 2 (100%) |
| Rejected | 0 | 0 |
| Withdrawn by sponsor | 0 | 0 |
| Returned/failed screening | 0 | 0 |
| Total | 4 (100%) | 2 (100%) |
2.2.3 Other applications
Other application types that we process include requests for advice for the purpose of listing a medicine as a pharmaceutical benefit. 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.
| 2017-18 | 2018-19 | |
|---|---|---|
| July to June | ||
| Number (% of Total) | ||
| Requests for advice for the purpose of listing a medicine as a pharmaceutical benefit | ||
| B1 | 0 | 2 (100%) |
| B3 | 0 | 0 |
| Total | 0 | 2 (100%) |
| Requests for consent under section 14/14A of the Act to import, export or supply therapeutic goods not complying with an applicable standard | ||
| Approved | 10 (100%) | 21 (95%) |
| Rejected | 0 | 1 (5%) |
| Total | 10 (100%) | 22 (100%) |