You are here

Half yearly performance report - January to June 2015

16 December 2015

Book pagination

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 Australian Register of Therapeutic Goods (ARTG).

Table 12: Registered complementary medicine applications by outcome
2014 2015
Jan-Jun Jul-Dec Jan-Jun
New medicines
Approved 0 3 1
Rejected 0 1 0
Withdrawn 0 0 0
Returned/failed screening 0 0 0
Total new applications completed 0 4 1
Variations
Approved 5 15 13
Rejected 0 1 0
Withdrawn 0 0 1
Returned/failed screening 0 0 0
Total variations completed 5 16 14
Application for consent to import, supply or export goods under section 14/14A of the Acta
Approved N/Ab N/Ab 0
Rejected N/Ab N/Ab 0
Total applications a completed N/Ab N/Ab 0
  1. Applications can be made for consent to import, supply or export goods under section 14/14A of the Therapeutic Goods Act 1989.
  2. N/A - This data is not available as it was not being collected for these periods.

3.2 New ingredients permitted for use in listed medicines

Table 13: New listed medicine ingredient applications by outcome
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Approved 2 4 1
Rejected 4 0 1
Withdrawn 0 0 0
Returned/failed screening 0 0 0
Total completed 6 4 2

3.3 Listed medicines

Table 14: New listed medicines
2014 2015
Jan-Jun Jul-Dec Jan-Jun
New listed medicines 970 1 022 857
Table 15: Listed medicine variations under section 9D of the Therapeutic Goods Act 1989
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Approved N/Aa N/Aa 56
Rejected N/Aa N/Aa 3
Total N/Aa N/Aa 59
  1. N/A - This data is not available as it was not being collected for these periods.

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 in the ARTG is incomplete or incorrect.

Table 16: Listed medicine applications under section 14/14A of the Therapeutic Goods Act 1989
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Exemption Granted N/Aa N/Aa 2
Rejected N/Aa N/Aa 1
Total N/Aa N/Aa 3
  1. N/A - This data is not available as it was not being collected for these periods.

Sponsors can apply for certain exemptions under Section 14 of the Therapeutic Goods Act 1989. Applications seeking 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 17: Listed medicines investigations undertaken and outcomes
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Initiated investigations 49 38 48
Completed investigations
Medicines prioritised for targeted review N/Aa N/Aa 24
Referred to another TGA area or government organisation N/Aa N/Aa 5
No further action taken N/Aa N/Aa 24
Total completed investigations 32 46 53
  1. N/A - This data is not available as it was not being collected for these periods.

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; 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 cancelled the medicine or information was not available to conduct the review and the review was closed and the compliance status was unable to be determined.
Table 18: Listed medicine reviews
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Initiated reviews
Targeted reviews 47 21 20
Random reviews 22 13 76
Total 69 34 96
Reviews on hand 178 86 102
Completed reviews
Targeted reviews 68 113 43
Random reviews 21 20 36
Total 89 133 79
Table 19: Outcomes of completed listed medicine reviews
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Compliance status determined
Medicines with no compliance breaches 18 23 20
Medicines with verified compliance breaches 43 80 38
Sub-total 61 103 58
Compliance status unable to be determined
Medicines cancelled by sponsors after request for information 18 18 13
Medicines not yet manufactured 10 12 6
Other 0 0 2
Sub-total 28 30 21
Product not a therapeutic good 0 0 0
Total completed 89 133 79

Figure 1: Outcomes of compliance reviews by reason for initiation

Figure 1 is a pie chart broken down into the percentage of outcomes for compliance reviews by reason for initiation for January to June 2015.

We are currently focussing on performing a higher number of random reviews than in previous periods to better inform our targeted compliance program. In this period, we were able to determine the compliance status of approximately three quarters of reviews we performed, and of these, around 34% were compliant. This is a higher rate of compliance compared to the previous period.

Text version of Figure 1
  • Compliance status determined - 73%
    • No compliance breaches - 34%
      • Target - 50%
      • Random - 50%
  • Compliance status unable to be determined - 27%
    • Medicines cancelled by sponsor after request for information - 62%
      • Target - 77%
      • Random - 23%
    • Medicines not yet manufactured - 29%
      • Random - 67%
      • Target - 33%
    • Other - 9%
      • Random - 100%
    • Verified compliance breaches - 66%
      • Target 55%
      • Random - 45%

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 20: Types of listed medicine compliance issues identified
2014 2015
Jan-Jun Jul-Dec Jan-Jun
Information provided in ARTG entry 4 3 6
Manufacturing, quality and/or formulation 8 6 9
Labelling and/or advertising 49 34 26
Evidence 14 25 17
Safety 0 0 0
Other 6 40 4

Figure 2: Types of compliance issues identified by reason for initiation

Figure 2 are pie charts broken down into random and targetted reviews for January to June 2015.
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. It is apparent that compliance issues relating to evidence requirements dominate the types of issues identified during random reviews, while labelling/advertising issues are the most common issues identified during targeted reviews. A possible explanation for the higher proportion of labelling/advertising issues for targeted reviews may be that targeted reviews are often informed by complaints or referrals of potential non-compliance issues. As labelling and advertising requirements are easily accessible public information about listed medicines, these issues are often raised with the TGA more frequently and may explain the higher rate.

Text version of Figure 2
  • Random reviews
    • Evidence - 45%
    • Lab elling/advertising - 35%
    • Quality - 17%
    • ARTG information - 3%
  • Targeted reviews
    • Labelling/advertising - 49%
    • ARTG information - 15%
    • Quality - 12%
    • Other - 12%
    • Evidence - 12%
Table 21: Actions taken following listed medicine reviews
Actions following a Request for Information
Medicines found to be compliant and review concluded 20
Medicines cancelled by the TGA without a proposal to cancel notice 1
Proposal to cancel notice sent by the TGA 37
Total 58
Actions following Proposal to Cancel notice
Medicines cancelled by the TGA 6
Medicines cancelled by sponsors after being notified of compliance breaches 10
Reviews concluded after compliance breaches were addressed 21
Sub-total 37
  • 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 3: Actions taken following listed medicine reviews categorised by compliance status

Figure 3 is a pie chart broken down into the outcomes of listed medicines reviews for January to June 2015.

Figure 3 shows that a significant proportion of listed medicines 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 the TGA to ensure the supply of compliant medicines on the ARTG.

Text version of figure 3
  • Non-compliant - 66%
    • Review concluded after compliance breaches addressed - 37%
    • Medicine cancelled by Sponsor after being notified of compliance breaches - 17%
    • Medicine cancelled by TGA after a proposal to cancel notice - 10%
    • Medicine cancelled by TGA without a proposal to cancel notice - 2%
  • Compliant - 34%
    • Medicine found to be compliant and review concluded - 34%

Book pagination