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Annual performance statistics report: July 2016 to June 2017

12 September 2017

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8. Access to unapproved therapeutic goods

8.1. Special Access Scheme

The 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, two 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 that do not fit the Category A definition. An approval letter from TGA is required before the goods may be accessed.

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 43 SAS medicine notifications and applications
  2015-16 2016-17
July to June
Category A notifications
Total Category A notifications 38,806 46,678
Category B applications
Approved 19,307 21,609
Cancelled 312 355
Rejected 51 21
Pending at end of reporting period 443 418
Total Category B applications 20,113 22,403
Table 44 SAS device notifications and applications
  2015-16 2016-17
July to June
Category A notifications
Total 3,922 4,914
Category B applications
Approved 2,081 2,113
Cancelled 116 96
Rejected 20 1
Pending at end of reporting period 16 135
Total 2,233 2,345
Table 45 SAS biological notifications and applications
  2015-16 2016-17
July to June
Category A notifications
Total 44 47
Category B applications
Approved 3,171 2,024
Cancelled 25 89
Rejected 0 0
Pending at end of reporting period 35 44
Total 3,231 2,157

8.2. Clinical trials

The Clinical Trial Notifications (CTN) scheme provides an avenue through which unapproved therapeutic goods may be lawfully supplied for use solely for experimental purposes in humans. Unapproved therapeutic goods can include biologicals, devices or medicines or a combination of any of the three types of goods.

Table 46 Number of notifications for new clinical trials involving unapproved therapeutic goods received by therapeutic good type
  2015-16 2016-17
July to June
Therapeutic good type
Medicine 458 409
Devicea 155 152
Biological 21 10
Medicine and device 288 290
Device and biological 6 1
Medicine and biological 14 6
Medicine, device and biological 7 0
Total 949 868
  1. 'Device' includes both medical device and therapeutic device categories.
Table 47 Number of new clinical trial notifications involving unapproved therapeutic goods received by phase
  2015-16 2016-17
July to June
Clinical trial type
Phase 1 205 191
Phase 2 217 189
Phase 3 301 257
Phase 4 146 89
Devicea N/A 118
Bioavailability/equivalence 39 24
None specifiedb 134 N/A
  1. In previous reports 'Device' was not available as a phase category under the previous CTN system.
  2. It is now always possible to specify phase and the 'None specified' category will no longer be used.
Table 48 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
  2015-16 2016-17
July to June
Therapeutic good type
Medicine 1,090 1,230
Devicea 249 266
Biological 31 12
Medicine and device 1,072 1,417
Device and biological 20 2
Medicine and biological 37 10
Medicine, device and biological 27 1
Total 2,526 2,938
  1. Device includes both medical device and therapeutic device categories.

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 49 Number of new clinical trials and variationsa to previously notified clinical trials involving unapproved therapeutic goods received by phase
  2015-16 2016-17
July to June
Phases
Phase 1 415 459
Phase 2 598 648
Phase 3 1,177 1,358
Phase 4 274 246
Deviceb N/A 194
Bioavailability/equivalence 46 33
None specifiedc 217 N/A
  1. 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.
  2. In previous reports 'Device' was not available as a phase category under the previous CTN system.
  3. It is now always possible to specify phase and the 'None specified' category will no longer be used.

8.3. 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 50 Authorised Prescriber approvals for medicines, medical devices and biologicals
  2015-16 2016-17
July to June
Approvals by therapeutic good type
Number of approvals for medicines 661 764
Number of approvals for medical devices 238 304
Number of approvals for biologicals 0 1

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