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Annual performance statistics report: July 2016 to June 2017

12 September 2017

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3. Complementary medicines

3.1. Registered complementary medicines

Registered complementary medicines are considered to be of relatively higher risk than listed medicines based on their ingredients or the indications for the medicine. These medicines are fully evaluated by us for quality, safety and efficacy prior to being accepted on the ARTG.

Table 14 Registered complementary medicine applications by outcome
  2015-16 2016-17
July to June
New medicines
Approved 2 6
Rejected 0 1
Withdrawn 1 3
Returned/failed screening 0 0
Total new applications completed 3 10
Variations
Approved 27 20
Rejected 0 1
Withdrawn 3 3
Returned/failed screening 0 0
Total variations completed 30 24
Application for consent to import, supply or export goods under section 14/14A of the Acta
Approved 1 1
Rejected 0 0
Total applications completed 1 1
  1. Applications can be made for consent to import, supply or export goods under section 14/14A of the Therapeutic Goods Act 1989.

3.2. New ingredients permitted for use in listed medicines

Table 15 New listed medicine ingredient applications by outcome
  2015-16 2016-17
July to June
Application outcome
Approved 18a 79b
Rejected 0 0
Withdrawn 0 1
Returned/failed screening 2 0
Total completed 20 80
  1. This includes 10 ingredients that were permitted as per the Therapeutic Goods (Listing) Notice 2015 (No. 4) following TGA initiated assessments.
  2. This includes a large number of ingredients that were made available for excipient use in specific circumstances in listed medicines following TGA initiated assessments.

3.3. Listed medicines

Table 16 New listed medicines
  2015-16 2016-17
July to June
New listed medicines 1,644 1,581
Table 17 Listed medicine variations under section 9D of the Therapeutic Goods Act 1989
  2015-16 2016-17
July to June
Medicine variation
Approved 102 85
Rejected 16 4
Total 118 89

Section 9D of the Therapeutic Goods Act 1989 provides for variations to be made to an entry on the ARTG in a set of limited and prescribed circumstances. These circumstances include where information included on the ARTG is incomplete or incorrect.

Table 18 Listed medicine applications under section 14/14A of the Therapeutic Goods Act 1989
  2015-16 2016-17
July to June
Application
Exemptiona granted 7 7
Rejected 4 2
Total 11 9
  1. Sponsors can apply for certain exemptions under Section 14 of the Therapeutic Goods Act 1989. Applications seek consent to import, export or supply a complementary medicine that does not comply with the applicable standards.Listed medicine reviews

3.3.1 Investigations

Investigations include 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 assessed and triaged based on a risk management approach to provide the greatest overall benefit for the Australian public. Investigations may be completed through a number of mechanisms, such as initiating a targeted review or referral to another area of the TGA.

Table 19 Listed medicine investigations undertaken and outcomes
  2015-16 2016-17
July to June
Initiated investigations 114 201
Completed investigations
Medicines prioritised for targeted review 69 134
Referred to another TGA area or government organisation 14 18
No further action takena 32 54
Total completed investigations 115 206
  1. The outcome 'no further action taken' includes examples where the investigation was resolved by other means such as the product has been or is currently under review; the complaint was not justified and did not warrant further action; or advice was provided to the complainant.

3.3.2 Compliance reviews

Listed medicines are not evaluated by the TGA before they are included on the ARTG. However, a proportion is reviewed 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.
Table 20 Listed medicine reviews by type
  2015-16 2016-17
July to June
Initiated reviews
Targeted reviews 173 504
Random reviews 340 87
Total 513 591
Reviews on hand 151 189
Completed reviews
Targeted reviews 158 421
Random reviews 315 130
Total 473 551
Table 21 Completed listed medicine reviews by outcome
  2015-16 2016-17
July to June
Compliance status determined
Medicines with no compliance breaches 81 87
Medicines with verified compliance breaches 327 330
Sub-total 408 417
Compliance status unable to be determined
Medicines cancelled by sponsors after request for information 43 74
Medicines not yet manufactured 19 58
Other 1 1
Sub-total 63 133
Product not a therapeutic good 2 1
Total completed 473 551

Figure 4 Outcomes of compliance reviews by reason for initiation

circle chart

In this period, we have performed a higher proportion of targeted reviews than in 2015-16. We initiated a number of targeted compliance projects based on the compliance data obtained from the previous reporting period. These projects have covered oral probiotics indicated for vaginal conditions and listed medicines with blood glucose and cholesterol indications. Of the reviews where we were able to determine a compliance status, 79% had verified compliance breaches, which is consistent with the non-compliance rate from the previous period, despite the different proportion of random to targeted reviews.

Table 22 Types of listed medicine compliance issues identified

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.

Table 22 Types of listed medicine compliance issues identified
  2015-16 2016-17
July to June
Type of compliance issue
Information provided in ARTG entry 53 119
Manufacturing, quality and/or formulation 63 62
Labellinga 110 94
Advertisinga 71 86
Unacceptable presentationa 119 140
Evidenceb 210 180
Safetyc 13 22
Non-response to a request for informationd 6 8
Otherd 2 4
  1. In previous reports 'Labelling', 'Advertising' and 'Unacceptable presentation' were reported collectively as 'Labelling and/or advertising'. The 2015-16 data has been updated to incorporate the additional breakdown of categories. 'Unacceptable presentation' includes the presentation (labelling, packaging and any advertising material) being misleading to consumers and text and graphics being unacceptable.
  2. 'Evidence' means the evidence held by the sponsor does not support the claims relating to the medicine.
  3. 'Safety' means that the medicine is not safe for the purposes for which it is to be used.
  4. In previous reports 'other' included non-response to a request for information. However this is now being reported separately.

Figure 5 Types of compliance issues identified by reason for initiation

pie charts showing types of compliance issues for random reviews and targeted reviews
Compliance issue Random reviews Targeted reviews
Evidence 23% 23%
Unacceptable presentation 22% 15%
Advertising code 10% 12%
Labelling 27% 17%
Quality 6% 9%
ARTG entryc 9% 19%
Safety 1% 4%
Non-response to RFIa 1% 1%
Otherb 1% 0%

Figure 5 shows the types of compliance issues that are identified through reviews which are either randomly selected or targeted for a particular issue. Multiple breaches may be identified for each medicine that is found to be non-compliant; for example, 54% of non-compliant medicines were found to have insufficient evidence to support the medicine indication, yet this breach accounted for 23% of the total breaches identified across all non-compliant medicines.

  1. 'RFI' refers to 'Requests For Information'.
  2. 'Other' compliance issues may include the sponsor failing to comply with a condition that the medicine is subject to.
  3. 'ARTG entry' broadly refers to situations where the information on the ARTG is incorrect, including indications that are not eligible for listing and ingredients that do not comply with listing requirements.

For both random and targeted reviews, the most common compliance issues have consistently been labelling/ advertising and evidence issues. For targeted reviews in 2016-17, there was a slightly higher proportion of compliance issues related to the ARTG, quality or safety, whereas in 2015-16 there was a significantly higher proportion of evidence and labelling/advertising issues. This is likely to be the result of a number of targeted compliance projects undertaken during this period that focussed on these issues.

Table 23 Actions taken following listed medicine reviews
  2015-16 2016-17
July to June
Actions following a Request for Information
Medicines found to be compliant and review concluded 81 87
Medicines cancelled by the TGA without a proposal to cancel notice 0 0
Proposal to cancel notice or warninga sent by the TGA 327 330
Total 408 417
Actions following Proposal to Cancel noticeb
Medicines cancelled by the TGA 44 17
Medicines cancelled by sponsors after being notified of compliance breaches 76 84
Reviews concluded after compliance breaches were addressed 207 229
  1. In some targeted review projects, sponsors are sent a 'warning' letter instead of a 'proposal to cancel' letter. A proposal to cancel or warning letter are considered the same for reporting purposes.
  2. The figures provided under 'Actions following a Proposal to Cancel notice' are a breakdown of the figures provided under 'Actions following a Request for Information'.

Figure 6 Outcomes of completed compliance reviews

Compliant 21%; Compliant after Proposal to Cancel or warning 55%; Cancelled by sponsor request after Proposal to Cancel or warning 20%; Cancelled by TGA after Proposal to Cancel or warning 4%
Outcome Percent
Compliant 21%
Compliant after Proposal to Cancel or warning 55%
Cancelled by sponsor request after Proposal to Cancel or warning 20%
Cancelled by TGA after Proposal to Cancel or warning 4%

Figure 6 shows that a significant proportion of listed medicine reviews are concluded after the sponsor has adequately addressed the compliance breaches identified by us. Under the Therapeutic Goods Act 1989 sponsors are given an opportunity to respond to issues raised during a compliance review. There was a slight decrease in the number of listed medicines cancelled by the TGA following a Proposal to cancel or warning letter (4%) compared with the previous period (11%). The high proportion of listed medicines that are brought back into compliance after a Proposal to cancel, combined with the decrease in listed medicines cancelled by the TGA, shows that industry is willing to work with us to ensure the supply of listed medicines on the ARTG is compliant.

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