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Annual performance statistics report: July 2018 to June 2019

21 October 2019

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4. Listed medicines

Listed medicines are considered to be of relatively lower risk than other medicines on the basis that they can only contain pre-approved ingredients and indications. Unlike registered medicines, we do not assess each listed medicine before it goes onto the market. However, we do require sponsors to certify that the medicine complies with all relevant legislation, and that they hold evidence at the time of listing (and at all times) that their medicine does what it says it will.

We may select a listed medicine for a post-market review where we require the sponsor to provide evidence of compliance with regulation. This includes assessment of evidence of efficacy and labelling. If we find the medicine does not comply with all applicable regulatory requirements, the medicine's listing may be suspended or cancelled.

4.1. New ingredients permitted for use in listed medicines

Table 19 New listed medicine ingredient applications by outcome
2017-18 2018-19
July to June
Application outcome
Approved 24 (86%) 15 (88%)
Rejected 0 1 (6%)
Withdrawn 3 (11%) 1 (6%)
Returned/failed screening 1 (4%) 0
Total completed 28 (100%) 17 (100%)

4.2. Indications permitted for use in listed medicines

Table 20 Permitted indication applications by outcome
2017-18 2018-19
July to June
Application outcome
Approved 0[a] 2 (18%)
Rejected 0[a] 5 (46%)
Withdrawn 0[a] 4 (36%)
Total completed 0[a] 11 (100%)

Footnotes


4.3. Listed medicines

Table 21 New listed medicines
2017-18 2018-19
July to June
New listed medicines 1792 1893

Subsection 9D(1) of the Act provides for variations to be made to an entry on the ARTG where information included on the ARTG is incomplete or incorrect. These variations are considered by a delegate. Other types of variations to listed medicines are applied for and processed automatically by the online application system.

Table 22 Listed medicine variations under section 9D(1) of the Act
2017-18 2018-19
July to June
Number (% of Total)
Medicine variation
Approved 91 (95%) 131 (78%)
Rejected 5 (5%) 13 (8%)
Withdrawn N/A[a] 24 (14%)
Total 96 (100%) 168 (100%)

Footnotes


Table 23 Listed medicine applications under section 14/14A of the Therapeutic Goods Act 1989
2017-18 2018-19
July to June
Number (% of Total)
Application
Exemption granted[a] 9[b] (100%) 11 (85%)
Rejected 0 0
Withdrawn N/A[c] 2 (15%)
Total 9[b] (100%) 13 (100%)

Footnotes


4.3.1 Investigations

Investigations arise from notifications, complaints and referrals from internal and external stakeholders and screening of recently listed medicines on the ARTG, but can also include products not listed on the ARTG. All investigations are prioritised based on a risk management approach to provide the perceived greatest overall benefit for the Australian public. Investigations may be completed with a number of actions, such as initiating a targeted review or referral to another area of the TGA.

Table 24 Listed medicine investigations and actions undertaken
2017-18 2018-19
July to June
Number (% of Total)
Initiated investigations 56 81
Completed investigations[a] 55 36
Initiated compliance review(s) 22 (40%) 20 (55%)
Issued warning or educational letter 0 (0%) 1 (3%)
Advice provided to complainant 0 (0%) 0 (0%)
Referred to another TGA area or government organisation 4 (7%) 1 (3%)
No further action taken[b] 29 (53%) 14 (39%)
Total actions undertaken[c] 55 (100%) 36 (100%)

Footnotes


4.3.2  Compliance reviews

Listed medicines are not individually evaluated by the TGA before they are included on the ARTG. However, a proportion is reviewed post-market to check their compliance against relevant regulatory requirements. Compliance reviews may only review selected listing requirements.

Medicines may be randomly selected or targeted for a review. Medicines are randomly selected for review by a computer, based on a mathematical model. Targeted reviews can originate from a number of signals and are initiated following an investigation.

A compliance review will result in one of the following outcomes:

  • no compliance breaches are identified against selected listing requirements, the review is concluded and the medicine remains on the ARTG
  • compliance breaches are identified for the selected listing requirements
  • the review is not completed as the sponsor has cancelled the medicine
  • the review is closed due to the unavailability of information in determining its compliance status as the medicine is yet to be manufactured.
Table 25 Listed medicine reviews by type
2017-18 2018-19
July to June
Number (% of Total)
Initiated reviews
Targeted reviews 82 (36%) 127 (91%)
Random reviews 143 (64%) 12 (9%)
Total 225 (100%) 139 (100%)
Reviews on hand 173 131
Completed reviews
Targeted reviews 162 (67%) 99 (55%)
Random reviews 81 (33%) 82 (45%)
Total 243 (100%) 181 (100%)
Table 26 Completed listed medicine reviews by outcome
2017-18 2018-19
July to June
Number (% of Total)
Compliance status determined
Medicines with no compliance breaches 42 (25%) 38 (27%)
Medicines with verified compliance breaches 129 (75%) 102 (73%)
Sub-total 171 (100%)
-70%
140 (100%)
-77%
Compliance status unable to be determined
Medicines cancelled by sponsors after request for information 51 (74%) 30 (73%)
Medicines not yet manufactured 13 (19%) 11 (27%)
Other 5 (7%) 0 (0%)
Sub-total 69 (100%)
-28%
41 (100%)
-23%
Product not a therapeutic good 3 (1%) 0 (0%)
Total completed 243 (100%) 181 (100%)
Figure 4 Outcomes of compliance reviews by reason for initiation[a]
[Targeted: 70% Determined, 30% Unable to be determined; Random: 87% Determined, 13% Unable to be determined]; [Status: Determined - Targeted: 43% No breaches, 57% Verified breaches; Random: 11% No breaches, 89% Verified breaches]; [Status: Unable to be determined - Targeted 77% Cancelled by sponsor after request for information, 23% Not yet manufactured; Random 64% Cancelled by sponsor after request for information, 36% Not yet manufactured]

Footnotes


Compliance status determination
Compliance status determination Determined Unable to be determined
Targeted 70% 30%
Random 87% 13%
Status: Determined
Status: Determined No breaches Verified breaches
Targeted 43% 57%
Random 11% 89%
Status: Unable to be determined
Status: Unable to be determined Cancelled by sponsor after request for information Not yet manufactured
Targeted 77% 23%
Random 64% 36%

Of the completed compliance reviews, the following are the types of issues identified in those medicines where a compliance breach was verified. Individual medicines may have multiple issues identified.

Table 27 Types of listed medicine compliance issues identified
2017-18 2018-19
July to June
Number (% of Total)
Type of compliance issue
Information provided in ARTG entry[a] 69 (21%) 30 (12%)
Manufacturing, quality and/or formulation 27 (8%) 15 (6%)
Labelling 58 (17%) 49 (20%)
Advertising 59 (18%) 40 (16%)
Unacceptable presentation[b] 63 (19%) 52 (21%)
Evidence[c] 50 (15%) 51 (21%)
Safety[d] 0 1 (0.4%)
Non-response to a request for information[e] 5 (2%) 2 (1%)
Other[f] 2 (1%) 4 (2%)
Total 333 (100%) 244 (100%)

Footnotes


Figure 5[a] Types of compliance issues identified by reason for initiation
Advertising: 13% Targeted, 18% Random; Evidence: 18% Targeted, 22% Random; Information provided in ARTG entry: 13% Targeted, 12% Random; Labelling: 19% Targeted, 20% Random; Manufacturing, quality and/or formulation: 6% Targeted, 6% Random; Non-response: 4% Targeted, 1% Random; Other: 1% Targeted, 1% Random; Unacceptable presentation: 25% Targeted, 19% Random.

Footnotes


Figure 5[a] Types of compliance issues identified by reason for initiation
Compliance issue Targeted Random
Advertising 13% 18%
Evidence 18% 22%
Information provided in ARTG entry 13% 12%
Labelling 19% 20%
Manufacturing, quality and/or formulation 6% 6%
Non-response 4% 1%
Other 1% 1%
Unacceptable presentation 25% 19%
Table 28 Actions taken following listed medicine reviews
2017-18 2018-19
July to June
Number (% of Total)
Actions following a Request for Information
Medicines found to be compliant and review concluded 42 (25%) 38 (27%)
Medicines cancelled by the TGA without a proposal to cancel notice 0 0
Proposal to cancel notice or warning[a] sent by the TGA 129 (75%) 102 (73%)
Total 171 (100%) 140 (100%)
Actions following Proposal to Cancel notice[a] by outcome
Medicines no longer on the ARTG 55 (100%)
-43%
32 (100%)
-31%
Cancelled by the TGA 10 (18%) 3 (9%)
Cancelled by sponsors after being notified of compliance breaches 45 (82%) 29 (91%)
Medicines remaining on the ARTG 74 (100%)
-57%
70 (100%)
-69%
Reviews concluded after compliance breaches were addressed 74 (100%) 70 (100%)
Total 129 (100%) 102 (100%)

Footnotes


Figure 6[a] Outcomes of completed compliance reviews
50% Compliant after Proposal to Cancel or Warning; 21% Cancelled by sponsors after Proposal to Cancel or Warning; 27% Compliant; 2% Cancelled by the TGA after Proposal to Cancel or Warning

Footnotes


Figure 6[a] Outcomes of completed compliance reviews
Outcome Percent
Compliant after Proposal to Cancel or Warning 50%
Cancelled by sponsors after Proposal to Cancel or Warning 21%
Compliant 27%
Cancelled by the TGA after Proposal to Cancel or Warning 2%

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