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Annual performance statistics report: July 2018 to June 2019
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9. Access to unapproved therapeutic goods
9.1. Special Access Scheme
The Special Access Scheme (SAS) refers to arrangements which provide for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. For this reporting period, three pathways existed under the scheme and they are categorised as follows:
- Category A is a notification pathway which can only be accessed by medical practitioners for patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
- Category B is an application pathway which can be accessed by health practitioners for patients who do not fit the Category A definition. An approval letter from the TGA is required before the goods may be accessed.
- Category C is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use are specified in a list along with their indications and the type of health practitioner authorised to supply these products.
Any unapproved therapeutic good can potentially be supplied via the SAS except for drugs of abuse in Schedule 9 of the Poisons Standard (where the manufacture, possession, sale or use is prohibited by state or territory law) which cannot be accessed through the SAS Category A process.
2017-18 | 2018-19 | ||||||
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July to June | |||||||
Number (% of Total) | |||||||
Category A notifications | |||||||
Total Category A notifications | 36,881 (58%) |
39,911[a] (47%) |
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Category B applications | |||||||
Approved | 11641 (96%) | 18388 (88%) | |||||
Cancelled | 40 (0.3%) | 168 (0.8%) | |||||
Withdrawn | N/A | 802 (4%) | |||||
Rejected | 28 (0.2%) | 1 (0%) | |||||
Pending at end of reporting period[b] | 370 (3%) | 1464 (7%) | |||||
Total Category B applications | 12079 (100%) (19%) |
20823 (100%) (24%) |
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Category C notifications | |||||||
Total Category C notifications | 14560 (23%) |
24505[a] (29%) |
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Total SAS notifications/applications received (all categories) | 63520 (100%) |
85239[a] (100%) |
Footnotes
[a] | Due to system technical issues, the number of notifications received during some of this reporting period has been estimated. |
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[b] | Pending applications are waiting on additional information to be supplied by the applicant. |
2017-18 | 2018-19 | ||||||
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July to June | |||||||
Number (% of Total) | |||||||
Category A notifications | |||||||
Total Category A notifications | 4,511 (62%) | 5117[a] (60%) | |||||
Category B applications | |||||||
Approved | 2,466 (94%) | 1,953 (90%) | |||||
Cancelled | 15 (0.6%) | 24 (1%) | |||||
Withdrawn | N/A | 51 (2%) | |||||
Rejected | 9 (0.3%) | 13 (0.6%) | |||||
Pending at end of reporting period[b] | 143 (5%) | 142 (7%) | |||||
Total Category B applications | 2,633 (100%) (36%) |
2,183 (100%) (25%) |
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Category C notifications | |||||||
Total Category C notifications | 177 (2%) | 1394[a](16%) | |||||
Total SAS notifications/applications received (all categories) | 7,321 (100%) | 8,694 (100%) |
Footnotes
[a] | Due to system technical issues, the number of notifications received during some of this reporting period has been estimated. |
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[b] | Pending applications are waiting on additional information to be supplied by the applicant. |
2017-18 | 2018-19 | |
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July to June | ||
Number (% of Total) | ||
Category A notifications | ||
Total Category A notifications | 110 (7%) | 89[a] (4%) |
Category B applications | ||
Approved | 711 (98%) | 1350 (92%) |
Cancelled | 8 (1%) | 15 (1%) |
Withdrawn | N/A | 55 (4%) |
Rejected | 0 | 26 (2%) |
Pending at end of reporting period[b] | 9 (1%) | 30 (2%) |
Total Category B applications | 728 (100%) (44%) |
1476[a] (100%) (66%) |
Category C notifications | ||
Total Category C notifications | 802 (49%) | 688[a](31%) |
Total SAS notifications/applications received (all categories) | 1640 (100%) | 2253 (100%) |
Footnotes
[a] | Due to system technical issues, the number of notifications received during some of this reporting period has been estimated. |
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[b] | Pending applications are waiting on additional information to be supplied by the applicant. |
9.2. Clinical trials
The Clinical Trial Notifications scheme provides an avenue through which unapproved therapeutic goods may be supplied for use solely for clinical trials. Unapproved therapeutic goods can include biologicals, devices or medicines or a combination of any of the three types of goods.
2017-18 | 2018-19 | |
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July to June | ||
Number (% of Total) | ||
Therapeutic good type | ||
Medicine | 436 (45%) | 466[b] (44%) |
Device[a] | 143 (16%) | 173[b] (16%) |
Biological | 7 (1%) | 13[b] (1%) |
Medicine and device | 325 (35%) | 391[b] (37%) |
Device and biological | 1 (0.1%) | 4[b] (0.4%) |
Medicine and biological | 5 (1%) | 4[b] (0.4%) |
Medicine, device and biological | 3 (0.3%) | 8[b] (0.8%) |
Total | 920 (100%) | 1059[b] (100%) |
Footnotes
[a] | 'Device' includes both medical device and therapeutic device categories. |
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[b] | Due to system technical issues, the number of notifications received during some of this reporting period has been estimated. |
2017-18 | 2018-19 | |
---|---|---|
July to June | ||
Number (% of Total) | ||
Clinical trial type | ||
Phase 1 | 262 (29%) | 285 (27%) |
Phase 2 | 209 (23%) | 264 (25%) |
Phase 3 | 246 (27%) | 260 (25%) |
Phase 4 | 65 (7%) | 82 (8%) |
Device | 125 (14%) | 147 (14%) |
Bioavailability/equivalence | 13 (1%) | 21 (2%) |
Total | 920 (100%) | 1059 (100%) |
2017-18 | 2018-19 | |
---|---|---|
July to June | ||
Number (% of Total) | ||
Therapeutic good type | ||
Medicine | 1154 (39%) | 1201 (38%) |
Device[a] | 240 (8%) | 287 (9%) |
Biological | 12 (0.4%) | 19 (0.6%) |
Medicine and device | 1557 (52%) | 1643 (52%) |
Device and biological | 5 (0.1%) | 9 (0.3%) |
Medicine and biological | 11 (0.4%) | 10 (0.3%) |
Medicine, device and biological | 4 (0.1%) | 16 (0.5%) |
Total | 2983 (100%) | 3185 (100%) |
Footnotes
[a] | Device includes both medical device and therapeutic device categories. |
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The online system captures the actual number of notifications received for new clinical trials and requests to change significant details to clinical trials already notified. A variation to a previously notified clinical trial may include an addition of a site(s), change to a therapeutic good, or change in principal investigator etc.
2017-18 | 2018-19 | |
---|---|---|
July to June | ||
Number (% of Total) | ||
Phases | ||
Phase 1 | 612 (20%) | 687 (22%) |
Phase 2 | 707 (24%) | 921 (29%) |
Phase 3 | 1280 (43%) | 1196 (37%) |
Phase 4 | 165 (5%) | 123 (4%) |
Device | 195 (7%) | 227 (7%) |
Bioavailability/equivalence | 24 (1%) | 31 (1%) |
Total | 2983 (100%) | 3185 (100%) |
Footnotes
[a] | A variation may include any change to a previously notified clinical trial such as an additional site, change to a therapeutic good, or change in principal investigator. |
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9.3. Authorised Prescribers
The Authorised Prescriber Scheme allows approved medical practitioners authority to prescribe a specified unapproved therapeutic good(s) to patients who are identified by their medical condition. If a medical practitioner becomes an Authorised Prescriber they may prescribe the product to patients in their immediate care, within the indication specified, without seeking further approval from the TGA.
2017-18 | 2018-19 | |
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July to June | ||
Number (% of Total) | ||
Approvals by therapeutic good type | ||
Number of approvals for medicines | 605 (60%) | 694 (57%) |
Number of approvals for medical devices | 407 (40%) | 527 (43%) |
Number of approvals for biologicals | 0 | 1 (0.1%) |
Total | 1012 (100%) | 1222 (100%) |