You are here

Annual performance statistics report: July 2018 to June 2019

21 October 2019

Book pagination

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.

Table 50 SAS medicine notifications and applications
2017-18 2018-19
July to June
Number (% of Total)
Category A notifications
Total Category A notifications 36,881
(58%)
39,911[a]
(47%)
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Withdrawn N/A 802 (4%)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%)
Category C notifications
Total Category C notifications 14560
(23%)
24505[a]
(29%)
Total SAS notifications/applications received (all categories) 63520
(100%)
85239[a]
(100%)

Footnotes


Table 51 SAS device notifications and applications
2017-18 2018-19
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%)
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


Table 52 SAS biological notifications and applications
2017-18 2018-19
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


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.

Table 53 Number of notifications for new clinical trials involving unapproved therapeutic goods received by therapeutic good type
2017-18 2018-19
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


Table 54 Number of new clinical trial notifications involving unapproved therapeutic goods received by phase
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%)
Table 55 Number of notifications for new clinical trials and variations to previously notified clinical trials, including non-fee attracting variations, involving unapproved therapeutic goods received by therapeutic good type
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


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.

Table 56 Number of new clinical trials and variations[a] to previously notified clinical trials involving unapproved therapeutic goods received by phase
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


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.

Table 57 Authorised Prescriber approvals for medicines, medical devices and biologicals
2017-18 2018-19
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%)

Book pagination