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Performance statistics report: July 2015 to June 2016

28 September 2016

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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 the TGA for quality, safety and efficacy prior to being accepted on the ARTG.

Table 13 Registered complementary medicine applications by outcome
2014-15
Jul-Jun
2015-16
Jul-Jun
New medicines
Approved 4 2
Rejected 1 0
Withdrawn 0 1
Returned/failed screening 0 0
Total new applications completed 5 3
Variations
Approved 28 27
Rejected 1 0
Withdrawn 1 3
Returned/failed screening 0 0
Total variations completed 30 30
Application for consent to import, supply or export goods under section 14/14A of the Act[a]
Approved 0[b] 1
Rejected 0[b] 0
Total applications completed 0[b] 1
  • [a] Applications can be made for consent to import, supply or export goods under section 14/14A of the Therapeutic Goods Act 1989.
  • [b] Data collection commenced January 2015.

3.2. New ingredients permitted for use in listed medicines

Table 14 New listed medicine ingredient applications by outcome
2014-15
Jul-Jun
2015-16
Jul-Jun
Approved 5 18[a]
Rejected 1 0
Withdrawn 0 0
Returned/failed screening 0 2
Total completed 6 20

[a] This includes 10 ingredients that were permitted as per the Therapeutic Goods (Listing) Notice 2015 (No. 4) following TGA initiated assessments.

3.3. Listed medicines

Table 15 New listed medicines
2014-15
Jul-Jun
2015-16
Jul-Jun
New listed medicines 1,879 1,644
Table 16 Listed medicine variations under section 9D of the Therapeutic Goods Act 1989
2014-15
Jul-Jun
2015-16
Jul-Jun
Approved 56[a] 102
Rejected 3[a] 16
Total 59[a] 118

[a] Data collection commenced January 2015.

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 17 Listed medicine applications under section 14/14A of the Therapeutic Goods Act 1989
2014-15
Jul–Jun
2015-16
Jul–Jun
Exemption granted 2[a] 7
Rejected 1[a] 4
Total 3[a] 11

[a] Data collection commenced January 2015.

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.

3.4. Listed medicine reviews

3.4.1. 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 18 Listed medicine investigations undertaken and outcomes
2014-15
Jul–Jun
2015-16
Jul–Jun
Initiated investigations 86 114
Completed investigations
Medicines prioritised for targeted review 24[a] 69
Referred to another TGA area or government organisation 5[a] 14
No further action taken 24[a] 32
Total completed investigations 99[a] 115

[a] Data collection against categories commenced January 2015. There were a total of 46 completed investigations for the period Jul-Dec 2014.

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.

3.4.2. 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, 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 19 Listed medicine reviews by type
2014-15
Jul-Jun
2015-16
Jul-Jun
Initiated reviews
Targeted reviews 41 173
Random reviews 89 340
Total 130 513
Reviews on hand 188 151
Completed reviews
Targeted reviews 156 158
Random reviews 56 315
Total 212 473
Table 20 Completed listed medicine reviews by outcome
2014-15
Jul–Jun
2015-16
Jul-Jun
Compliance status determined
Medicines with no compliance breaches 43 81
Medicines with verified compliance breaches 118 327
Sub-total 161 408
Compliance status unable to be determined
Medicines cancelled by sponsors after request for information 31 43
Medicines not yet manufactured 18 19
Other 2 1
Sub-total 51 63
Product not a therapeutic good 0 2
Total completed 212 473

Figure 4 Outcomes of compliance reviews by reason for initiation

Outcomes of compliance reviews by reason for initiation

In this period, we have more than doubled the number of compliance reviews completed compared to the previous period. We have also performed a higher proportion of random reviews to better inform our targeted compliance program. Of the reviews where we were able to determine a compliance status, 80% had verified compliance breaches, which is a higher rate of non-compliance than the previous period (73%).

Table 21 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 21 Types of listed medicine compliance issues identified
2014-15
Jul-Jun
2015-16
Jul-Jun
Information provided in ARTG entry 9 53
Manufacturing, quality and/or formulation 15 63
Labelling and/or advertising 60 215
Evidence 42 210
Safety 0 13
Other 44 8

Figure 5 Types of compliance issues identified by reason for initiation

Types of compliance issues identified by reason for initiation

Figure 2 shows the types of compliance issues that are identified through reviews which are either randomly selected or targeted for a particular issue.

'Other' compliance issues may include the sponsor failing to comply with a condition that the medicine is subject to or not responding to a formal request for information.

For both random and targeted reviews, the most common compliance issues have consistently been labelling/ advertising and evidence issues. In this period, evidence and labelling/advertising issues were comparable for targeted reviews, whereas last period there were a significantly higher proportion of labelling/advertising issues. This is likely the result of a number of targeted compliance projects that we have undertaken during this period that focussed on evidence issues identified during our random review program.

Table 22 Actions taken following listed medicine reviews
Actions following a Request for Information
Medicines found to be compliant and review concluded 81
Medicines cancelled by the TGA without a proposal to cancel notice 0
Proposal to cancel notice sent by the TGA 327
Total 408
Actions following Proposal to Cancel notice
Medicines cancelled by the TGA 44
Medicines cancelled by sponsors after being notified of compliance breaches 76
Reviews concluded after compliance breaches were addressed 207
Sub-total 327

The figures provided under 'Actions following Proposal to Cancel notice' are a sub-set of the figure provided under 'Actions following a Request for Information'.

Figure 6 Outcomes of completed compliance reviews

Outcomes of completed compliance reviews

Figure 3 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. This high proportion also 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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