Each year the TGA provides information on our regulatory performance through the Annual Performance Statistics Report and the Half Yearly Performance Snapshot. We also report annually on our performance under the Regulator Performance Framework through the TGA Self-Assessment (Key Performance Indicators) Report.
The following statistics cover the period 1 July 2016 to 30 June 2017 and contribute to our suite of performance reports.
Key observations for 2016-17 are summarised below, including trends and notable changes from previous reporting periods.
Since the 2015-16 report, the number of submissions received across some Category 1 application types varied significantly. While the number of New Chemical Entity submissions remained constant, the number of Extension of Indication submissions increased noticeably and the number of generic medicine submissions greatly decreased. All Category 1 submissions processed in 2016-17 were within the legislated 255 working day timeframe and, on average, were decided in 220 working days or less.
The total number of new medicine applications received in 2016-17 was slightly higher than in 2015 16 with an increase in the number of low risk (N1) and medium risk (N3) applications. In the higher risk (N4 and N5) categories, applications received in 2016-17 were roughly half that received in 2015 16. The total number of applications received to vary existing medicines decreased substantially compared with 2015-16, mostly due to a decrease in the number of low risk (C1) applications. The number of higher risk variation (C2, C3 and C4) applications was consistent with previous periods.
While median approval times for new medicine applications in 2016-17 were longer by approximately 2 weeks compared with 2015-16, the percentage of applications processed within target time continued to be at, or very close to 100%. The longer median approval times can be attributed to the increase in the number of lower risk and medium risk applications as well as varying level of complexity of higher risk applications.
The number of new ingredients approved for use in listed medicines significantly increased to 79 in 2016-17 compared with 18 in 2015-16, primarily due to a number of excipient ingredients with limited availability being added to the Therapeutic Goods (Permissible Ingredients) Determination under section 26BB of the Therapeutic Goods Act 1989.
The number of post market compliance reviews completed has remained similar with 10% more reviews completed in 2016-17 than in 2015-16. Investigations, which arise from complaints from the public, industry referrals and adverse event reporting, increased in 2016-17 compared with 2015-16. Investigations are assessed using a risk prioritisation system and where required, will result in a compliance review being initiated.
The rate of verified compliance breaches has remained similar; 79% in 2016-17 compared with 80% in 2015-16. This suggests that the significant increase in the number of compliance reviews in recent years has not driven any improvement in compliance rates. The proportion of medicines found to be non-compliant for which breaches included 'insufficient evidence being held by the sponsor to support the medicine indication' was similar; 54% in 2016-17 compared with 64% in 2015-16.
Labelling, advertising and evidence continued to be major compliance breaches for listed medicines. In 2016-17, 22 products were found to have safety related issues, compared with 13 products in 2015-16. This increase was largely a result of continued targeted work undertaken on reviewing the safety of ingredients.
The number of approved new registered complementary medicines increased to 10 in 2016-17 compared with 3 in 2015-16. The total number of variations completed in 2016-17 decreased to 24 compared with 30 in 2015-16.
The number of new and variation applications stabilised following the transition of most biologicals into the new biologicals regulatory framework during 2014-15. The number of Technical Master File variations increased due to work by the public cord blood banks.
Overall, adverse event reporting increased from 17,633 medicine and vaccine adverse event notifications in 2015-16 to 19,736 in 2016-17. In particular, the increased number of vaccine Adverse Event Reports may reflect recent additions to the National Immunisation Program in 2016. Adverse event reporting from members of the public also increased which is likely to be the result of activity to promote consumer adverse event reporting.
An increase in incident reports in 2016-17 resulted from media attention, sponsor training workshops in 2016 to increase awareness, and expansion of the Insite program.
There was a significant increase in the number of Level 2 compulsory audits of applications for inclusion of Class III and Active Implantable Medical Devices on the ARTG, which include the assessment of clinical evidence, completed in 2016-17 (471) compared with 2015-16 (205). We refined our processes for clinical evidence assessment in relation to audits and built the capability of our assessment teams to improve assessment timeframes for new medical devices. Concurrent assessments by staff with differing expertise, triage of applications and better application of the risk based approach to assessment of evidence for different categories of devices resulted in reduced waiting times for commencement of the audits of applications seeking pre-market authorisation from 8-9 months to about one month. By the end of the reporting period this significantly increased the completion rate of assessments and improved patients' access to new medical devices.
The number of new export medicine listing applications and variations remained constant over the last two years. The number of export certificates for medicines dropped in 2016-17 by 25%, however there was an increase in the number of device certificates issued. All medicine certificates were issued within the target timeframe of 15 days. Over 80% of device certificates and new listings and variations were also completed within the target timeframe.
All human blood and tissue permits were released within the 24 hour target timeframe to ensure that emergency demands overseas were met.
The number of notifications and applications for most Special Access Scheme (SAS) categories increased since 2015-16, especially Category A for both medicines and devices. An exception is SAS Category B for biologicals as higher volume products previously accessed through SAS are now on the ARTG.
Demand for Good Manufacturing Practice (GMP) clearances continued to increase with 6,506 applications received during 2016-17 compared with 5,657 in 2015-16. Major contributing factors included sponsors sourcing more products from new and multiple manufacturers, globalisation and company mergers, and overseas regulatory agencies undertaking more inspections in other countries, creating more evidence to be used in support of Australian GMP clearance applications.
There was a significant decrease in the number of medicine recalls from 57 in 2015-16 to 32 in 2016-17, and a slight decrease from 611 in 2015-16 to 598 in 2016-17 in the number of medical device recalls.
Over the past four years there has been a continued increase in the failure rate of products tested by the TGA Laboratories on a contract basis for external agencies such as the World Health Organization (WHO) and other governments within the region. This increase was again observed in 2016-17. These results highlight the important role we play in supporting other governments to identify sub-standard, degraded or adulterated medicines supplied for use in other countries, and helping to ensure continued health security for the region, including Australia.
Investigations increased by 64% in 2016-17, with 2,887 completed compared with 1,760 in 2015-16. The largest contributor to investigations continues to be referrals from Australian Border Force in relation to the importation of unapproved prescription medicines.
Applications to register new or vary existing prescription medicines are accompanied by supportive scientific data and evaluated, with timeframes underpinned by legislation and/or associated business rules.
The framework for prescription medicines includes the following categories which are subject to legislated timeframes:
The legislated timeframes for the two stages of a Category 1 application are: 40 working days for notification of acceptance or rejection of the application and 255 working days for the completion of the evaluation and notification of the decision.
The legislated timeframes for the two stages of a Category 2 application are: 20 working days for notification of acceptance or rejection of an application and 175 working days to notify the applicant of the decision.
The legislated timeframe for a Category 3 application is 45 working days for notification of acceptance or rejection of an application, completion of evaluation and notification of the decision.
Once an application has been accepted by the TGA, the approval time is defined as the number of TGA working days until a decision is made. As detailed above, this timeframe is underpinned by legislation and excludes public holidays, weekends, the time allocated to the applicant to provide responses to requests for information and 'mutual clock stop' periods agreed with the applicant.
In accordance with the Therapeutic Goods Regulations 1990, a 'submission' may include a number of applications submitted at the one time. The data presented below relates to submissions as this best reflects the evaluation and decision-making processes.
Approval time (TGA working days) | |||||
---|---|---|---|---|---|
Application type | Submissions approved | Legislated timeframe | Mean | Median | Range |
A: New chemical entity | |||||
Category 1 | 38 | 255 | 220 | 208 | 161-238 |
B: New fixed-dose combination | |||||
Category 1 | 4 | 255 | 201 | 203 | 179-218 |
C: Extension of indication | |||||
Category 1 | 45 | 255 | 198 | 202 | 106-238 |
D: New generic medicine | |||||
Category 1 | 111 | 255 | 182 | 172 | 109-254 |
E: Additional trade name (ATN) | |||||
Category 1 | 2 | 255 | 140 | 140 | 44-237 |
ATN | 47 | 45 | 34 | 36 | 10-62 |
F: Major variation | |||||
Category 1 | 46 | 255 | 185 | 185 | 134-226 |
G: Minor variation | |||||
Category 1 | 0 | 255 | N/A | N/A | N/A |
Category 3 | 104 | 45 | 27 | 26 | 8-43 |
H: Minor variation | |||||
Category 1 | 4 | 255 | 142 | 143 | 111-172 |
Category 3 | 1,253 | 45 | 24 | 23 | 1-51 |
J: Changes to Product Information requiring the evaluation of data | |||||
Category 1 | 63 | 255 | 142 | 140 | 46-228 |
Median approval time (TGA working days) | |||
---|---|---|---|
Application type | Legislated timeframe | 2015-16 | 2016-17 |
A: New chemical entity | |||
Category 1 | 255 | 199 | 208 |
B: New fixed-dose combination | |||
Category 1 | 255 | 167 | 203 |
C: Extension of indication | |||
Category 1 | 255 | 195 | 202 |
D: New generic medicine | |||
Category 1 | 255 | 158 | 172 |
E: Additional trade name (ATN)a | |||
Category 1 | 255 | 219 | 140 |
ATN | 45 | 35 | 36 |
F: Major variation | |||
Category 1 | 255 | 183 | 185 |
G: Minor variationb | |||
Category 1 | 255 | 163 | 0 b |
Category 3 | 45 | 19 | 26 |
H: Minor variationc | |||
Category 1 | 255 | 146 | 143 |
Category 3 | 45 | 20 | 23 |
J: Changes to Product Information requiring the evaluation of data | |||
Category 1 | 255 | 134 | 140 |
Figure 1 Submissions received 2015-16 to 2016-17
Figure 2 Mean approval times 2015-16 to 2016-17
Figure 3 Median approval times 2015-16 to 2016-17
Submission Type | Approved | Withdrawn | Rejected | Total |
---|---|---|---|---|
A: New chemical entity | 38 | 4 | 0 | 42 |
B: New fixed-dose combination | 4 | 2 | 0 | 6 |
C: Extension of indication | 45 | 2 | 2 | 49 |
D: New generic medicine | 111 | 2 | 2 | 115 |
E: Additional trade name (ATN) (Category 1) | 2 | 0 | 0 | 2 |
E: ATN | 47 | 1 | 0 | 48 |
F: Major variation | 46 | 2 | 1 | 49 |
G: Minor variation | 104 | 2 | 0 | 106 |
H: Minor variation (Category 1) | 4 | 0 | 0 | 4 |
H: Minor variation (Category 3) | 1,253 | 16 | 0 | 1,269 |
J: Changes to Product Information | 63 | 3 | 0 | 66 |
Total | 1,717 | 34 | 5 | 1,756 |
In addition to the application types discussed above, we also process numerous other application types. These applications are assessed in accordance with a risk-based approach, for example, some requests are categorised as 'self-assessable' and do not usually involve the evaluation of scientific data. Some applications are received because the sponsors are obliged to inform the TGA of new information related to the safety of their products. Other applications involve editorial corrections to the register entry or the associated product information document. The number of these applications is presented below.
In accordance with the legislation, registered medicines must comply with numerous standards at the time they are registered and throughout their lifecycle. Following an appropriate application and review of the scientific data and safety considerations, we may grant an 'exemption' from a particular standard for a product. The number of applications approved and rejected is also presented below.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Prescription medicine applications | ||
Safety related request | 781 | 738 |
Self-assessable request | 1,404 | 1,244 |
Minor editorial change to product information | 481 | 459 |
Correction of error | 123 | 124 |
Total | 2,789 | 2,565 |
Exemptions to comply with a standard | ||
Approved | 88 | 89 |
Rejected | 0 | 1 |
Total | 88 | 90 |
'Orphan drugs' are often developed to treat small and very specific patient populations who suffer from rare diseases and conditions. The application and evaluation fees for orphan drugs can be waived to help reduce their development costs and facilitate their access to the Australian marketplace. A medicine needs to be designated by the TGA as an orphan drug before an application can be accepted to register it on the ARTG. The designation process involves a review of whether the drug meets the established criteria which are underpinned by legislation.
The quality, efficacy and safety of orphan drugs are assessed at the same standard as for other registered prescription medicines.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Number of designations | 22 | 29 |
Over-the-Counter (OTC) medicine applications are categorised as new medicine (N) or change (C) applications and are further categorised by risk (N1 and C1 are low risk, N5 and C4 are highest risk). The OTC application categorisation framework outlined below defines the different OTC medicine application levels and the key application criteria.
Application category | Definition |
---|---|
N1 | An application submitted as a 'Clone'. |
N2 | An application which complies with an OTC medicine monograph. |
N3 | New application for a 'generic' medicine other than those 'generic' applications in levels N1, N2 or N4. |
N4 |
An application for a 'generic' medicine where the medicine:
|
N5 | An application for a new product that is an extension to a 'generic category' product or an application for a product containing a new chemical entity as an active ingredient. |
C1 | Quality and non-quality changes classified as 'negligible risk'. |
C2 | Quality and non-quality changes classified as 'low risk' ' no safety and/or efficacy data required; quality data may be required. |
C3 |
Quality and non-quality changes classified as 'low risk' ' safety and/or efficacy data required unless justified; quality data may be required. Umbrella branding segment of new name requires a higher level of assessment. |
C4 | Non-quality changes classified as 'moderate risk' ' safety and/or efficacy data required unless justified. |
B1 | Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that does not contain clinical data. |
B3 | Request for advice in relation to a registered OTC medicine for the purpose of listing the medicine as a pharmaceutical benefit that contains clinical data or a justification as to why such data is not needed. |
Requests for consent under section 14/14A of the Act | Request for consent by the Secretary under sections 14 and 14A of the Act to the import, export or supply of therapeutic goods that do not comply with an applicable standard. |
Approval time is defined as the number of working days from the acceptance of the application until formal notification of decision. Approval time excludes time where we were unable to progress the application until the sponsor provided additional information unless otherwise specified.
We aim to have 80% of applications completed within target timeframes. Target timeframes for processing of applications are a result of new OTC pre-market business processes and are subject to ongoing review.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
New medicine applications (days) | ||
N1 | 14 | 27 |
N2 | 26 | 43 |
N3 | 90 | 94 |
N4 | 89 | 106 |
N5 | 151 | 192 |
Change applications (days) | ||
C1 | 5 | 7 |
C2 | 8 | 14 |
C3 | 31 | 14 |
C4 | 110 | 86 |
Application type | Number completed | Range | Mean | Median | Target time (days) | % within target |
---|---|---|---|---|---|---|
New medicines | ||||||
N1 | 93 | 0-41 | 25 | 27 | 45 | 100 |
N2 | 7 | 37-47 | 42 | 43 | 55 | 100 |
N3 | 29 | 16-143 | 88 | 94 | 150 | 100 |
N4 | 29 | 4-162 | 101 | 106 | 170 | 100 |
N5 | 8 | 45-196 | 167 | 192 | 210 | 100 |
Change applications | ||||||
C1 | 396 | 0-75 | 8 | 7 | 20 | 97 |
C2 | 226 | 0-78 | 21 | 14 | 64 | 99.6 |
C3 | 7 | 10-107 | 30 | 14 | 120 | 100 |
C4 | 1 | 86 | 86 | 86 | 170 | 100 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
New medicine applications (%) | ||
N1 | 100 | 100 |
N2 | 100 | 100 |
N3 | 100 | 100 |
N4 | 100 | 100 |
N5 | 83a | 100 |
Change applications (%) | ||
C1 | 97 | 97 |
C2 | 99 | 99.6 |
C3 | 100 | 100 |
C4 | 100 | 100 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
New medicine applications | ||
N1 | 75 | 108 |
N2 | 13 | 5 |
N3 | 30 | 44 |
N4 | 45 | 23 |
N5 | 14 | 6 |
Total | 177 | 186 |
Change applications | ||
C1 | 632 | 387 |
C2 | 312 | 276 |
C3 | 8 | 7 |
C4 | 1 | 2 |
Total | 953 | 672 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
N1 | ||
Approved | 79 | 93 |
Rejected | 0 | 0 |
Withdrawn by sponsor | 0 | 1 |
Returned/failed screening | 1 | 0 |
Total | 80 | 94 |
N2 | ||
Approved | 3 | 7 |
Rejected | 0 | 0 |
Withdrawn by sponsor | 0 | 1 |
Returned/failed screening | 5 | 0 |
Total | 8 | 8 |
N3 | ||
Approved | 25 | 29 |
Rejected | 0 | 0 |
Withdrawn by sponsor | 7 | 2 |
Returned/failed screening | 7 | 3 |
Total | 39 | 34 |
N4 | ||
Approved | 50 | 29 |
Rejected | 0 | 0 |
Withdrawn by sponsor | 0 | 0 |
Returned/failed screening | 5 | 6 |
Total | 55 | 35 |
N5 | ||
Approved | 6 | 8 |
Rejected | 0 | 0 |
Withdrawn by sponsor | 1 | 0 |
Returned/failed screening | 5 | 0 |
Total | 12 | 8 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
C1 | ||
Approved | 618 | 396 |
Rejected | 0 | 0 |
Withdrawn by sponsor | 15 | 10 |
Returned/failed screening | 0 | 0 |
Total | 633 | 406 |
C2 | ||
Approved | 309 | 226 |
Rejected | 0 | 0 |
Withdrawn by sponsor | 3 | 7 |
Returned/failed screening | 0 | 1 |
Total | 312 | 234 |
C3 | ||
Approved | 4 | 7 |
Rejected | 0 | 0 |
Withdrawn by sponsor | 0 | 1 |
Returned/failed screening | 0 | 2 |
Total | 4 | 10 |
C4 | ||
Approved | 12 | 1 |
Rejected | 0 | 0 |
Withdrawn by sponsor | 0 | 0 |
Returned/failed screening | 0 | 0 |
Total | 12 | 1 |
In addition to the application types discussed above, we also process other application types. This includes requests for advice for the purpose of listing a medicine as a pharmaceutical benefit. The number of requests is presented below.
In accordance with the legislation, registered goods must comply with numerous standards at the time they are registered and throughout their lifecycle. Following an appropriate application and review of the scientific data and safety considerations, we may grant an 'exemption from a particular standard for a product. The number of applications approved and rejected is also presented below.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Requests for advice for the purpose of listing a medicine as a pharmaceutical benefita | ||
B1 | N/A | 1 |
B3 | N/A | 1 |
Total | N/A | 2 |
Requests for consent under section 14/14A of the Act to import, export or supply therapeutic goods not complying with an applicable standardb | ||
Approved | N/A | 25 |
Rejected | N/A | 1 |
Total | N/A | 26 |
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.
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 |
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 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
New listed medicines | 1,644 | 1,581 |
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.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Application | ||
Exemptiona granted | 7 | 7 |
Rejected | 4 | 2 |
Total | 11 | 9 |
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.
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 |
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:
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 |
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
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.
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 |
Figure 5 Types of compliance issues identified by reason for initiation
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.
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.
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 |
Figure 6 Outcomes of completed compliance reviews
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.
The Australian Regulatory Guidelines for Biologicals define the different biological classes.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Applications received | ||
Technical Master File (TMF)a new | 2 | 0 |
TMF annual updates | 6 | 5 |
TMF variations | 9 | 20 |
TMF notifications | 7 | 27 |
Plasma Master Fileb annual updates | 15 | 11 |
Biological Class 2 - new applications | 2 | 4 |
Biological Class 3 - new applications | 2 | 0 |
Biological Class 2 - variations | 26 | 14 |
Biological Class 3 - variations | 2 | 1 |
Total received | 71 | 82 |
Applications on hand | ||
TMF new | 2 | 1 |
TMF annual updates | 4 | 4 |
TMF variations | 2 | 7 |
TMF notifications | 0 | 0 |
Plasma Master File annual updates | 3 | 4 |
Biological Class 2 - new applications | 3 | 6 |
Biological Class 3 - new applications | 4 | 3 |
Biological Class 2 - variations | 7 | 2 |
Biological Class 3 - variations | 1 | 0 |
Total on hand | 26 | 27 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Biologicals applications | ||
Technical Master File (TMF) new | 2 | 1 |
TMF annual updates | 5 | 5 |
TMF variations | 7 | 19 |
TMF notifications | 7 | 27 |
Plasma Master File annual updates | 14 | 7 |
Biological Class 2 - new applications | 4 | 1 |
Biological Class 3 - new applications | 0 | 1 |
Biological Class 2 - variations | 21 | 18 |
Biological Class 3 - variations | 5 | 2 |
Total completed | 65 | 81 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Reports with clear causality by reporter | ||
Hospitals | 2,194 | 1,850 |
Companies | 8,776 | 9,194 |
General practitioners | 644 | 573 |
Specialists | 221 | 245 |
Pharmacists | 883 | 1,063 |
Members of the public | 813 | 1,104 |
Nurses, dentists, complementary healthcare practitioners | 214 | 157 |
State/Territory Health departments | 2,619 | 3,274 |
Reports withdrawn, or rejected, or without clear causality | ||
1,269 | 2,276 | |
Total received | 17,633 | 19,736 |
Mean number of reports received weekly | 339 | 380 |
Vaccine reports included in this table | 3,361 | 4,020 |
The Medical Devices Regulatory Framework spans the life cycle for these products, including:
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Conformity assessment applications | ||
Applications received | 257 | 242 |
Applications on hand | 178 | 213 |
Applications completed | 187a | 204 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
New | ||
Approved | 49 | 37 |
Rejected | 3 | 1 |
Withdrawn / Lapsed | 23 | 20 |
Variation (changes and re-certifications) | ||
Approved | 91 | 124 |
Rejected | 3 | 2 |
Withdrawn / Lapsed | 18 | 20 |
Total | 187 | 204 |
Table 30 has been broken down into 'New' and 'Variation' assessment application to provide additional transparency and understanding. In reviewing the changes in reporting the final total was increased by one, as per updates to operational data.
We are required to complete conformity assessment applications within 255 working days.
Processing time is defined as the number of working days from the acceptance of the application until formal notification of decision. Under the Therapeutic Goods Regulations 1990, working days exclude public holidays and weekends. Processing time excludes time where we were unable to progress the application until the sponsor provided additional information unless otherwise specified.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
New devices | ||
Mean TGA processing time (days) | 133 | 129 |
Median TGA processing time (days) | 178 | 167 |
Variations (changes and recertifications) | ||
Mean TGA processing time (days) | 93 | 114 |
Median TGA processing time (days) | 71 | 101 |
During 2016-17, 100% of conformity assessment applications were completed within 200 working days.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Class I medical devicesa | ||
Applications received | 2,685 | 2,514 |
Applications completed | 2,690 | 2,431 |
Class I measuring medical devices | ||
Applications received | 48 | 51 |
Applications completed | 48 | 50 |
Applications on handb | 2 | 4 |
Class I sterile medical devices | ||
Applications received | 257 | 246 |
Applications completed | 253 | 255 |
Applications on handb | 11 | 3 |
Class IIa medical devices | ||
Applications received | 1,178 | 1,160 |
Applications completed | 1,206 | 1,178 |
Applications on handb | 58 | 51 |
Class IIb medical devices | ||
Applications received | 654 | 666 |
Applications completed | 716 | 682 |
Applications on handb | 40 | 34 |
Class III medical devices | ||
Applications received | 344 | 343 |
Applications completed | 249 | 471 |
Applications on handb | 313 | 180 |
Class III Joint Reclassification medical devicesc | ||
Applications received | 0 | 0 |
Applications completed | 355 | 203 |
Applications on handb | 294 | 94 |
Active Implantable Medical Devices (AIMD) | ||
Applications received | 49 | 48 |
Applications completed | 19 | 87 |
Applications on handb | 62 | 23 |
Class 1 IVDsd | ||
Applications received | 92 | 94 |
Applications completed | 112 | 91 |
Applications on handb | 1 | 4 |
Class 2 IVDs | ||
Applications received | 104 | 96 |
Applications completed | 148 | 94 |
Applications on handb | 10 | 12 |
Class 3 IVDs | ||
Applications received | 65 | 49 |
Applications completed | 131 | 45 |
Applications on handb | 11 | 15 |
Class 4 IVDs | ||
Applications received | 25 | 15 |
Applications completed | 29 | 15 |
Applications on handb | 0 | 0 |
Class I automatically included medical devices are not counted in the outcomes for inclusion applications as these applications cannot be rejected.
Number of applications | ||||||
---|---|---|---|---|---|---|
2015-16 | 2016-17 | |||||
Device Classification | Approved/ Accepted | Rejected/ Lapsed | Withdrawn | Approved/ Accepted | Rejected/ Lapsed | Withdrawn |
Class I | 2,690 | 0 | 0 | 2,431 | 0 | 0 |
Class I Measurement | 47 | 0 | 1 | 44 | 2 | 4 |
Class I Sterile | 234 | 0 | 19 | 248 | 0 | 7 |
Class IIa | 1,132 | 2 | 72 | 1,128 | 6 | 44 |
Class IIb | 679 | 1 | 36 | 659 | 3 | 20 |
Class III | 207 | 12 | 30 | 398 | 18 | 55 |
Class III Reclassification | 278 | 7 | 70 | 152 | 3 | 48 |
AIMD | 17 | 0 | 2 | 87 | 0 | 0 |
Class 1 IVDa | 112 | 0 | 0 | 84 | 0 | 7 |
Class 2 IVDa | 136 | 3 | 9 | 71 | 2 | 21 |
Class 3 IVDa | 123 | 1 | 7 | 37 | 0 | 8 |
Class 4 IVDa | 28 | 0 | 1 | 14 | 0 | 1 |
The agreed target time for Level 1 application audits is 30 TGA work days and for Level 2 application audits is 60 TGA work days (reflected in 'TGA days'). This does not include the period we are waiting for information or payment of fees (reflected in 'sponsor days').
2015-16 | 2016-17 | |||||
---|---|---|---|---|---|---|
Number of applications | Sponsor days | TGA daysa | Number of applications | Sponsor days | TGA daysa | |
Mean Processing Time | ||||||
Medical devices | ||||||
Applications completed without audit | 2,112b | 2,105 | ||||
Non-compulsory auditc | 497 | 30 | 43 | 310 | 42 | 55 |
Level 1 compulsory audit | 32 | 27 | 26 | 40 | 25 | 18 |
Level 2 compulsory audit | 205 | 55 | 161 | 471 | 74 | 159 |
IVDs | ||||||
Applications completed without audit | 148b | 77 | ||||
IVD non-compulsory audit | 17 | 41 | 65 | 10 | 35 | 46 |
IVD compulsory audit | 159 | 26 | 45 | 82 | 29 | 39 |
Median Processing Time | ||||||
Medical devices | ||||||
Applications completed without audit | 2,112b | 2,105 | ||||
Non-compulsory auditc | 497 | 21 | 21 | 310 | 27 | 24 |
Level 1 compulsory audit | 32 | 23 | 9 | 40 | 23 | 13 |
Level 2 compulsory audit | 205 | 49 | 158 | 471 | 60 | 155 |
IVDs | ||||||
Applications completed without audit | 148b | 77 | ||||
IVD non-compulsory audit | 17 | 33 | 58 | 10 | 22 | 36 |
IVD compulsory audit | 159 | 21 | 41 | 82 | 18 | 29 |
As Class I medical devices are automatically included on the ARTG, we undertake post-market compliance reviews for these devices. This includes restricted word reviews, where applications for Class I devices are identified by the use of specific words indicative of risk, or listing issues relating to the inclusion of the device.
We also conduct targeted compliance reviews that are initiated on a case by case basis. These may be conducted in relation to devices of any Class.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Restricted word reviews | ||
Reviews completed | 0 | 54 |
Reviews commenced | 1 | 55 |
Reviews on hand | 1 | 1 |
Targeted compliance reviewsa | ||
Reviews completed | 104 | 35 |
Reviews commenced | 83 | 45 |
Reviews on hand | 164 | 175 |
We also undertake a range of post market reviews.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Post market reviews | ||
Reviews commenced - number of ARTG entries | 80 | 396 |
Reviews completed - number of ARTG entries | 83 | 239 |
Reviews on hand - number of ARTG entries | 163 | 263 |
Processing time is defined as the number of working days from the receipt of the notification until the incident has been investigated and resolved. Under the Therapeutic Goods Regulations 1990, working days exclude public holidays and weekends.
The target timeframe for processing of medical device incident reports is 90 working days.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Device incident reports | ||
Reports received | 3,841 | 4,896 |
Reports completed | 3,608 | 4,918 |
Reports still in progress | 207 | 380 |
Processing time | ||
Mean TGA processing time (days) | 1 | 1 |
Median TGA processing time (days) | 14 | 10 |
Percentage processed within target timeframe | 100% | 95% |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Incident report outcome | ||
Reviewed and used for trend analysis purposes | 2,988 | 4,125 |
Reviewed, no further action required | 330 | 279 |
Product recall | 40 | 70 |
Recall for product correction | 19 | 4 |
Hazard alert | 25 | 22 |
Product notification | 1 | 0 |
Safety alert | 9 | 20 |
Product enhancement/improvement notice | 0 | 1 |
Instructions for use amended | 3 | 5 |
Referral for post-market review | 23 | 82 |
Refer to another TGA Branch | 51 | 39 |
Company warned | 0 | 13 |
Product suspended from ARTG | 0 | 0 |
Product cancelled from ARTG | 4 | 1 |
Manufacturing process improvements | 10 | 12 |
Quality system process improvements | 1 | 0 |
Maintenance carried out by the hospital | 0 | 0 |
Change to design | 13 | 3 |
Not device related | 9 | 16 |
Other | 39 | 81 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
QMS audits (Australia) | ||
Number of audits conducted | 38 | 38 |
Satisfactory compliance (of completed audits) | 79% | 71% |
Marginal compliance (of completed audits) | 21% | 24% |
Unacceptable (of completed audits) | 0% | 0% |
Close-out in Progress | 0% | 5% |
Processing time | ||
Initial audits conducted within 3 months of applicationa | 17% | 57% |
Re-audits conducted within 6 months of due date | 41% | 16% |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
QMS audits (overseas) | ||
Number of audits conducted | 20 | 26 |
Satisfactory compliance (of completed audits) | 75% | 92% |
Marginal compliance (of completed audits) | 15% | 0% |
Unacceptable (of completed audits) | 10% | 0% |
Close-out in Progress | 0% | 8% |
Processing time | ||
Initial certification audits conducted within 6 months of applicationa | 50% | 80% |
Certification re-audits conducted within 6 months of due date | 17% | 9% |
Processing time is defined as the number of working days from the acceptance of the application, including payment, until formal notification of decision. Under the Therapeutic Goods Regulations 1990, working days exclude public holidays and weekends. Processing time excludes time where we were unable to progress the application until the sponsor provided additional information unless otherwise specified.
The target timeframe for processing of export only medicine applications and variations is 31 working days.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
New applications | ||
Mean TGA processing time (days) | 21 | 25 |
Median TGA processing time (days) | 20 | 26 |
Percentage processed within target processing time | 98% | 75% |
Variations | ||
Mean TGA processing time (days) | 18 | 22 |
Median TGA processing time (days) | 16 | 22 |
Percentage processed within target processing time | 100% | 89% |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Export only applications | ||
Applications received | 241 | 242 |
Applications awaiting response from sponsor | 20 | 9 |
Applications completed | ||
Approved | 221 | 207 |
Withdrawn | 10 | 17 |
Total completed | 231 | 224 |
The target processing time for applications for an export certificate for a medicine is 15 working days.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Applications received | 2,124 | 1,582 |
Applications completed | ||
Approved | 2,127 | 1,413 |
Withdrawn | 18 | 3 |
Total completed | 2,145 | 1,416 |
Processing times | ||
Mean TGA processing time (days) | 12 | 12 |
Median TGA processing time (days) | 12 | 13 |
Percentage processed within target timea | 98% | 99% |
The target processing time for applications for an export certificate for a medical device is 5 working days.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Applications received | 496 | 553 |
Applications completed | ||
Export certificates issued | 483 | 504 |
Applications withdrawn | 3 | 10 |
Total completed | 486 | 514 |
Processing time | ||
Mean TGA processing time (days) | 4 | 4.5 |
Median TGA processing time (days) | 5 | 4 |
Percentage processed within target timea | 96% | 83% |
We issue permits to export human blood and its fractions (products derived from human blood) on receiving written applications from medical professionals, hospitals and bone banks. Most often these professionals or health organisations approach the Australian Red Cross Blood Service which then applies for the permit on their behalf. Very rarely an individual citizen may also apply with reference to his/her requirement, for example, a patient travelling overseas with Biostate® injections, which is a blood fraction and requires a permit to take it out of Australia.
In addition to issuing individual permits, the TGA also issues annual permits. Applications for these permits are submitted by commercial (pharmaceutical companies) or government organisations (such as the Australian Defence Force). The permits cover one year's worth of anticipated export supplies for these organisations.
Figure 7 Number of blood permits processed
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:
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.
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 |
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 |
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 |
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.
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 |
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 |
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 |
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.
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 |
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.
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 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Licence status (Australia) | ||
New licences granted | 15 | 9 |
Withdrawn application | 11 | 10 |
Revoked licences - at request of licence holder | 42 | 19 |
Revoked licences - TGA | 0 | 1 |
Suspended - at request of licence holder | 3 | 1 |
Suspended - TGA | 0 | 0 |
As at 30 June 2017, there were 247 Australian companies holding manufacturing licences covering 387 sites.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Inspection status (Australia) | ||
Number of inspections conducted | 220 | 185 |
Satisfactory compliance (of completed inspections) | 81% | 88% |
Marginal compliance (of completed inspections) | 18% | 10% |
Unacceptable (of completed inspections) | 1% | 2% |
Close-out in progress | 15% | 18% |
Processing time | ||
Initial inspections conducted within 3 months of application | 68% | 85% |
Re-inspections conducted within 6 months of due date | 54% | 61% |
The 2016-17 data excludes inspections conducted for Australian medical devices manufacturers. This information is now reported under medical devices as Quality Management System (QMS) audits of Australian manufacturers.
The number of initial inspections conducted within 3 months of application improved in 2016-17 due to improved internal processes and focused efforts on ensuring initial inspections were conducted in a timely manner.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Applications (overseas) | ||
New applications received | 38 | 46 |
Re-inspection applications | 52 | 38 |
Applications completed | ||
Certified | 44 | 33 |
Rejected | 28 | 59 |
Total completed | 72 | 92 |
As at 30 June 2017, there were 206 overseas manufacturers covering 207 manufacturing sites that were subject to TGA inspection and approximately 2,700 overseas manufacturing sites that relied on evidence from recognised regulators.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Inspection status (overseas) | ||
Number of inspections conducted | 76 | 58 |
Satisfactory compliance (of completed inspections) | 95% | 94% |
Marginal compliance (of completed inspections) | 4% | 6% |
Unacceptable (of completed inspections) | 1% | 0% |
Close-out in progress | 18% | 10% |
Processing time | ||
Initial certification inspections conducted within 6 months of application | 40% | 64% |
Certification re-inspections conducted within 6 months of due date | 75% | 66% |
The 2016-17 data excludes inspections conducted for overseas medical devices manufacturers. This information is now reported under medical devices as QMS audits of overseas manufacturers.
The number of initial overseas inspections conducted within six months of application improved in 2016-17 due to improved internal processes and focused efforts on ensuring initial inspections were conducted in a timely manner.
GMP clearance is required for all medicines (unless exempt) supplied in Australia. This includes products supplied to sponsors by overseas manufacturers.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Applications received | 5,657 | 6,506 |
Applications completed | ||
Approved | 5,132 | 5,067 |
Rejected | 263 | 642 |
Total completed | 5,395 | 5,709 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Reason for recall | ||
Adverse reactions | 0 | 1 |
Foreign matter | 5 | 3 |
Illegal supply | 1 | 0 |
Impurity and degradation | 6 | 3 |
Labelling and packaging | 18 | |
Micro-organisms | 4 | 2 |
pH | 0 | 0 |
Potency | 5 | 3 |
Sterility | 1 | 0 |
Othera | 17 | 13 |
Total | 57 | 32 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Reason for recall | ||
Adverse incidents | 6 | 7 |
Diagnostic inaccuracy | 82 | 105 |
Electrical defect | 49 | 28 |
Illegal supply | 0 | 2 |
Labelling and packaging | 119 | 89 |
Mechanical and physical defects | 173 | 169 |
Software defects | 135 | 109 |
Sterility | 3 | 14 |
Othera | 44 | 75 |
Total | 611 | 598 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Recalls to hospital level | 0 | 2 |
The Laboratories Branch conducts post-market monitoring and compliance testing, investigations and reviews, as well as market authorisation assessment of therapeutic goods.
The Laboratories Branch identifies and prioritises therapeutic goods for testing to fulfil the regulatory compliance and monitoring requirements of the TGA, and the transparency and accountability requirements of government. The testing program also provides flexibility and capacity to provide testing for investigations into problem reports, complaints and urgent public health concerns.
A risk management approach is used, which is consistent with ISO 31000: Risk Management principals and guidelines, to identify products with a higher risk of not complying with the required quality standards. This risk based, targeted approach to testing is reflected in the failure rates reported in the table below.
The Database of TGA Laboratory Testing Results was launched in the first half of 2017 to provide information to the public about the 2000-plus samples we test each year, and to increase understanding of how our testing program contributes to the regulation of therapeutic goods. Consumers and health professionals can now clearly see which products have been tested by the TGA, whether they passed or failed, and for those that did fail what regulatory action was taken. Providing this information has been an important enhancement to the transparency of the Government's regulatory processes and the vital role of the TGA in ensuring the quality, safety and efficacy of medicines and medical devices for Australian consumers.
2015-16 | 2016-17 | ||
---|---|---|---|
July to June | |||
Therapeutic good type | |||
Prescription medicines | Total | 941 | 1,168 |
% fail | 0.5 | 0.9 | |
OTC medicines | Total | 47 | 51 |
% fail | 19.1 | 13.7 | |
Complementary medicines | Total | 108 | 87 |
% fail | 20.4 | 13.8 | |
Medical devices | Total | 114 | 168 |
% fail | 29.8 | 31 | |
Contracta | Total | 19 | 32 |
% fail | 36.8 | 62.5 | |
Unregisteredb | Total | 467 | 220 |
% fail | 76.2 | 63.6 | |
Total samples (excluding AHQ samples) | 1,696 | 1,726 | |
Total samplesc | 2,202 | 2,328 | |
Percentage fail | 25.50% | 14% | |
Total number of products testedd | 761 | 590 |
Medical devices | OTC medicines | Prescription medicines | Unregistered products | Complementary medicines | Total | |
---|---|---|---|---|---|---|
Reasons | ||||||
Contamination | 4 | 4 | 2 | 0 | 2 | 12 |
Formulation | 0 | 0 | 4 | 136 | 6 | 146 |
Label and packaging deficiencies | 8 | 2 | 0 | 0 | 0 | 10 |
Performance | 23 | 1 | 4 | 0 | 3 | 31 |
Physical or mechanical properties | 17 | 0 | 0 | 3 | 0 | 20 |
Unregistered | 0 | 0 | 0 | 1 | 1 | 2 |
Total | 52 | 7 | 10 | 140 | 12 | 221 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Batch releases and certifications | ||
Batch releasea | 401 | 453 |
Export certificationb | 59 | 75 |
The Laboratories Branch provides WHO-approved certificates for batches of biological products to be exported by Australian manufacturers to overseas markets. The number of certificates provided by the Laboratories Branch therefore depends on the number of requests received.
Priority of testing | Biochemical/chemical testing | Microbiological testing | Medical device testing |
---|---|---|---|
Urgent | 20 (95% of target times to be met) | 40 (95% of target times to be met) | 20 (95% of target times to be met) |
Priority | 40 (80% of target times to be met) | 50 (80% of target times to be met) | 40 (80% of target times to be met) |
Routine | 50 | 50 | 50 |
Testing on products linked to potential public safety concerns are assigned to the 'Urgent' testing category. Urgent testing may impact on the timeframes for priority and routing testing.
Priority is given to testing of products with the highest risk of a quality deficiency.
Compliance against these timeframes is outlined in the table below.
Priority | Total | Percentage | |
---|---|---|---|
Therapeutic good type | |||
Medical devices | Routine | 128 | 90% |
Priority | 33 | 94% | |
Urgent | 7 | 43% | |
OTC medicines | Routine | 34 | 56% |
Priority | 8 | 100% | |
Urgent | 9 | 100% | |
Prescription medicines | Routine | 141 | 63% |
Priority | 9 | 78% | |
Urgent | 6 | 83% | |
Complementary medicines | Routine | 56 | 66% |
Priority | 31 | 68% | |
Urgent | 0 | N/A | |
Unregistered products | Routine | 3 | 100% |
Priority | 213 | 95% | |
Urgent | 4 | 100% |
Low numbers of samples within categories may affect compliance percentages.
Samples involving complex biological assays are excluded from the target turnaround timeframes.
The TGA Regulatory Investigations and Enforcement Unit conducts compliance and enforcement activities against a risk based compliance framework. Using principles of responsive regulation, a range of tools are utilised including encouragement and guidance to comply, restrictions or warnings, suspensions or sanctions and cancellations. At the apex, activities including investigations into illegal import or manufacture of unapproved and counterfeit therapeutic goods can result in criminal or civil court action. All compliance activities have the intended purpose of protecting public health.
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Investigation in progress | 361 | 1,136 |
Completed investigations | ||
Warned (including destruction) | 946 | 1,973 |
No offence detected | 185 | 110 |
Goods released under Personal Import Scheme | 519 | 691 |
Referred to another agency or department outside Health | 28 | 21 |
Referred to another branch within the TGA | 10 | 13 |
Filed for intelligence purposes | 55 | 45 |
Finalised in a linked file | 11 | 25 |
Import treated as abandoned goods by Customs | 3 | 8 |
Recall of goods | 2 | 1 |
Matters referred to the Commonwealth Director of Public Prosecutions | 1 | 0 |
Total completed | 1,760 | 2,887 |
Goods (units) seized and destroyed at the point of importationa | N/A | 884,081 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Therapeutic good type | ||
Complementary medicines | 463 | 599 |
Prescription medicines | 1,802 | 4,367 |
Medical devices | 98 | 166 |
Homoeopathic medicines | 4 | 36 |
OTC medicines | 45 | 54 |
Biological products | 48 | 28 |
Other | 66 | 119 |
Total | 2,526 | 5,369 |
2015-16 | 2016-17 | |
---|---|---|
July to June | ||
Compliance investigation category | ||
Unapproved product | 2,110 | 4,855 |
Counterfeit product | 320 | 326 |
Parallel import/export | 9 | 28 |
Manufacture without licence | 1 | 8 |
Advertising offence | 17 | 19 |
Traditional Chinese medicines | 7 | 15 |
Othera | 7 | 33 |
Total | 2,471 | 5,284 |
Origin | ACT | NSW | NT | QLD | SA | VIC | WA | TAS | Othera | Total |
---|---|---|---|---|---|---|---|---|---|---|
Complaints resolution | 0 | 9 | 0 | 2 | 0 | 4 | 2 | 0 | 2 | 19 |
Customs | 4 | 2,373 | 37 | 136 | 12 | 412 | 190 | 0 | 5 | 3,169 |
External agency | 5 | 7 | 0 | 5 | 2 | 6 | 1 | 0 | 4 | 30 |
General public | 4 | 13 | 0 | 5 | 0 | 17 | 3 | 0 | 136 | 178 |
Patient/ practitioner | 0 | 1 | 0 | 1 | 1 | 2 | 0 | 0 | 2 | 7 |
Sponsor/client | 2 | 9 | 0 | 2 | 1 | 6 | 2 | 0 | 16 | 38 |
TGA internal | 51 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 52 |
Total | 66 | 2413 | 37 | 151 | 16 | 447 | 198 | 0 | 165 | 3,493 |
Version | Description of change | Author | Effective date |
---|---|---|---|
V1.0 | Original publication | Reporting and Collaboration Services | 12/09/2017 |