Annual performance statistics report: July 2017 to June 2018

27 September 2018
picture of report cover

About the Therapeutic Goods Administration

The Department of Health, through the Therapeutic Goods Administration (TGA) is responsible for assessing whether therapeutic goods available for supply in Australia are safe and fit for their intended purpose.

Products for which therapeutic claims are made are assessed by the TGA and entered on the Australian Register of Therapeutic Goods (ARTG). At 30 June 2018 there were 89,553 therapeutic goods on the ARTG. 11,032 new products were added to the ARTG during the reporting period. All therapeutic goods registered on the ARTG can be lawfully manufactured and supplied in Australia and include prescription medicines, over-the-counter medicines, complementary medicines, biologicals, and medical devices.

The TGA regulates the supply of:

  • medicines prescribed by a doctor or dentist
  • medicines available from behind the pharmacy counter
  • medicines available in the general pharmacy
  • medicines available from retail outlets
  • complementary medicines, such as vitamins, herbal and traditional medicines
  • medical devices, from simple devices like bandages to complex technologies like heart pacemakers
  • products used to test for various diseases or conditions (in vitro diagnostic devices (IVDs), such as blood tests
  • vaccines, blood products, and other biologics.

We play a regulatory role in overseeing the manufacturing process and advertising of therapeutic goods. We support compliance with the regulatory framework, working with state, territory and federal counterparts to remove unsafe/non-compliant therapeutic goods from the Australian market.

More information about how therapeutic goods are regulated in Australia can be found on our website.

Executive summary

Each year we provide information about our regulatory performance through the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. We also report annually on our performance against the Regulator Performance Framework through the TGA Self-Assessment (Key Performance Indicators) Report.

The statistics contained within this report cover the period 1 July 2017 to 30 June 2018, and contribute to annual publications that track our progress against the priorities we have established for the financial year.

Performance highlights: July 2017 to June 2018

Key observations for 2017-18 are summarised below, including trends and notable changes from previous reporting periods.

As part of our 2017-18 activity, we have continued to implement the Australian Government's Response to the Review of Medicines and Medical Devices Regulation (MMDR). Following the passage of amendments to the Therapeutic Goods Regulations 1990 that follow on from commencement of the Therapeutic Goods Amendment (2016 Measures No.1) Act 2017 and the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018, this reporting period now includes new data sets in relation to:

  • Orphan Drugs
  • Special Access Scheme
  • Authorised Prescriber Scheme
  • Priority pathways for medicines and medical devices
  • Pharmacovigilance Inspection Program
  • Provisional approval pathway for prescription medicines
  • An automated notification process for very low risk changes to biologicals and registered medicines
  • A pathway for use of un-redacted assessment reports from Comparable Overseas Regulators.

Reforms

Orphan drug program reform

Our reformed orphan drug program came into effect on 1 July 2017 and created a fairer program that aligns more closely with international criteria without impeding the availability of drugs for rare diseases. The reforms have also expanded the program to include new dosage form medicines.

The objective of the orphan drug program is to provide an incentive to sponsors to bring medicines for a small population to market and make medicines available to patients who would not otherwise be able to access them. The incentive is in the form of a waiver of application and evaluation fees.

Special Access Scheme

A new Special Access Scheme (SAS) pathway – Category C – was established in July 2017. Category C is a notification pathway allowing certain unapproved therapeutic goods that are deemed to have an established history of use to be supplied to an individual patient or class of patients without TGA approval. Under this pathway, health practitioners may be authorised to supply certain unapproved therapeutic goods for a particular indication as specified in legislative instruments. The introduction of Category C has enabled more streamlined access under the SAS.

Authorised Prescriber Scheme

A change to the application process of the Authorised Prescriber Scheme was implemented on 1 July 2017 to streamline access to unapproved therapeutic goods. This change removed the requirement for a medical practitioner to resubmit their clinical justification to the TGA, as this is required to be submitted to, and evaluated by, a Human Research Ethics Committee or specialist college. The duration of approval can now also be extended for therapeutic goods which are deemed to have an established history of use.

Priority review of prescription medicines

A new priority review pathway was also implemented on 1 July 2017. Priority review involves faster assessment of vital and life-saving prescription medicines for which a complete data dossier is available. The target timeframe of 150 working days is up to three months shorter than the standard prescription medicines registration process. The Priority review pathway operates with new and flexible business processes in order to facilitate faster assessment for registration, while maintaining our high standard for efficacy, safety and quality.

Pharmacovigilance Inspection Program

The inspection program involves TGA representatives interviewing sponsors and reviewing documents in order to assess sponsors' compliance with pharmacovigilance requirements. The program is largely based on the UK Medicines and Healthcare products Regulation Agency's successful pharmacovigilance inspection program, but also takes into consideration unique Australian factors. The launch of the program in September 2017 was preceded by substantial stakeholder engagement and consultation, particularly with medicine sponsors. The rollout was supported by a series of information sessions held around the country.

Provisional approval of prescription medicines

In March 2018, a new provisional approval pathway for prescription medicines was implemented. This pathway allows sponsors to apply for time-limited provisional registration on the ARTG on the basis of preliminary clinical data, providing access to certain promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.

Provisional registration is limited to a maximum of six years and will automatically lapse at the end of a specified period unless sponsors are able to demonstrate that they have met the conditions imposed on the provisional registration. Sponsors may apply for full registration when sufficient clinical data to confirm the safety and efficacy of the medicine are available.

Automated notifications for very low risk changes to registered medicines

A 'notifications' process was introduced in 2017 for very low risk changes to biologicals and to registered medicines. This process was implemented in two stages:

  • notifications to registered non-prescription medicines, launched in July 2017
  • notifications to biologicals and prescription medicines, launched in December 2017.

The new notifications processes are part of our improved risk-based approach to the management of variations.

Under the notifications process, an applicant uses an electronic form to request that certain types of changes be made to their medicines. For registered medicines, the request is automatically processed once it has passed electronic validation and the relevant fee has been paid. Manual processing is still required for notifications to biologicals.

Comparable Overseas Regulator report-based process

In January 2018, we implemented the Comparable Overseas Regulator report-based process for prescription medicines, replacing the Category 2 application process.

Report-based applications can relate to all types of new prescription medicines, including new chemical entities, new fixed dose combinations, generic medicines, biological medicines and biosimilars. This process can additionally be used for variations to existing medicines, including extension of indications or new dosage forms and changes to Product Information documents that would normally require evaluation of clinical data.

Prescription medicines

Fourteen priority review determinations and two provisional determinations were approved under the new priority review pathway and the new provisional approval pathway respectively. Of the 14 medicines receiving priority review determination, five were also approved for registration in 2017-18. The median timeframe for these registrations via the priority review pathway was 98 working days, against a target timeframe of 150 working days.

Eleven orphan drug designations were approved in 2017-18 under the reformed orphan drug program, with five additional designations approved under the previous orphan drug program (where the designation application was received prior to 1 July 2017). Twenty-one orphan drugs were approved in 2017-18, including one that received its designation under the reformed program.

A new prescription medicines minor variations form was also introduced, providing a single electronic form allowing sponsors to apply for minor variations.

Over-the-counter medicines

The total number of new medicine applications received was substantially higher than in 2016-17, with increases in the numbers of lower risk (N1, N2 and N3) and higher risk (N5) applications. The total number of applications received to vary existing medicines also increased substantially. The number of negligible risk (C1) applications decreased but was largely offset by the number of negligible-risk (CN) applications received (new notification application type implemented on 1 July 2017). The number of low risk variation (C2) applications increased substantially, in part due to receipt of applications for changes to labelling for compliance with the new labelling Order (Therapeutic Goods Order No. 92). The numbers of higher risk variation (C3 and C4) applications were consistent with previous years.

Median approval times for all new medicine application types were shorter than in 2016-17, but were consistent with previous years. Median approval times for higher risk variation (C2, C3, and C4) applications were longer than in 2016-17. For C2 applications this can be attributed to the large increase in the number of C2 applications received. Four out of five approved C3 applications were within target time and for all other application types the percentage of applications processed within target time continued to be at or close to 100%.

Listed medicines

The number of new listed medicines on the ARTG increased by 211 in 2017-18. This may be partly attributed to the introduction of permitted indications in March 2018.

The number of post-market compliance reviews completed decreased in 2017-18 due to a large and complex targeted review project of listed sunscreens having been undertaken over the course of the year. Investigations, which arise from complaints from the public, industry referrals and adverse event reporting, decreased. Investigations are assessed using a risk prioritisation system, and where required, will give rise to a compliance review being initiated.

Labelling, advertising and evidence continue to be major categories of compliance issues. No products were found to have issues posing a potential risk to consumer safety, compared with 22 products in 2016-17.

Biologicals

The number of new and variation applications has stabilised. The number of Technical Master File variations has decreased significantly over 2017-18, back to expected levels. The spike in numbers during 2016-17 was the result of major process alignment activity completed by the public cord blood banks during that year. The first Class 4 biological applications, representing a new class of therapeutic goods were received.

Medicine and vaccine adverse event reports

The total number of medicine and vaccine adverse event reports rose by 1,882 from 2016-17. The mean number of reports received weekly rose from 380 to 416 and the proportion of reports received from each category of reporter broadly matched 2016-17. The transition to a new Adverse Event Management System was initiated on 22 June 2018.

Medical device conformity assessment

The number of Conformity Assessment applications received during 2017-18 significantly increased compared with numbers submitted in 2016-17. We completed 273 applications compared with 204 in 2016-17, and have continued to refine and develop new guidance for industry which is resulting in better submissions and improved application processing.

Medical device incident reports

Medical device adverse event reports received increased by 452 in 2017-18. Media attention and the Senate Inquiry into transvaginal mesh accounts for an increase in reports by patients and carers, while continued education of health professionals on the value of reporting adverse events has led to an increase by them and sponsors.

Exports

The number of new export medicine listing applications and variations remained constant over the last two reporting periods. The number of export certificates for medicines increased by 14%, having dropped by 25% in 2016-17. There was again an increase in the number of device certificates issued (22%).

All human blood and tissue permits were released within the 24 hour target timeframe to ensure that emergency demands overseas were met.

Access to unapproved therapeutic goods

A notable change for this reporting period was the introduction of the aforementioned Special Access Scheme (SAS) pathway – Category C. There were 14,560 Category C notifications for medicines which resulted in sizeable falls in the other two SAS pathways. Overall there was a net decrease of 564 SAS notifications/ applications in 2017-18 with decreases observed for medicines and biologicals, and a small increase for devices compared to 2016-17.

Medicines and biologicals manufacturing

The number of inspections of Australian manufacturers increased by 25 in 2017-18 due to the number of new licence and variation applications received, as well as the number of re-inspections performed. The number of initial inspections conducted within 3 months of application for Australian manufacturers increased from 85% to 96%, which is due to manufacturers being ready for the inspection and the prioritisation of these inspections within the target timeframe. Similarly, re-inspections of Australian manufacturers conducted within 6 months increased from 61% to 72%, due to the prioritisation of these inspections to occur within the target timeframe. The number of inspections conducted for overseas manufacturers increased from 58 to 84, due to the number of re-inspections conducted.

Demand for Good Manufacturing Practice (GMP) clearances remained high with 5,327 applications received during 2017-18 compared with 5,471 in 2016-17. The decrease of 144 applications correlates to the decrease in rejected applications indicating an improvement in the quality of applications received. This is attributed to increased educational activities conducted by the TGA.

Recalls

Overall, the total number of recalls remained steady. There was a slight decrease in the number of medical device recalls, but a notable increase from two to 25 recalls for biological products. This may be attributed to increased stakeholder awareness of the overall regulatory framework for this product category.

Laboratory testing

A revised risk based process for targeting products for testing was implemented in 2017-18. The revised process resulted in improved accountability and transparency for the testing performed by the Laboratories Branch which is evidenced by the significant increase in the number of individual products tested this year. An increase was also seen in the number of complementary medicines tested as a result of improved targeting of products with a higher risk of non-compliance.

The first testing campaign under the Pacific Medicines Testing Program commenced in the second half of the year. The campaign included five Pacific Island Countries and focussed on antibiotics, paracetamol, and medications for diabetes and cardiovascular disease.

Regulatory compliance

Compliance and investigation and matters increased by 3.2% in 2017-18, with 2,982 matters completed. The largest contributor to the number of matters handled and investigated continues to be referrals from Australian Border Force in relation to the importation of unapproved prescription medicines.

1. Processing and approval times

27 September 2018

Processing and approval times are defined as the number of working days from the acceptance of an application until formal notification of decision, unless otherwise specified. These exclude times where we were unable to progress the application due to waiting for:

  • the sponsor to provide additional information;
  • payment of fees was received; or
  • 'mutual clock stop' periods agreed with the applicant or unless otherwise specified.

Under the Therapeutic Goods Act 1989 (the Act), TGA working days exclude public holidays and weekends. The timeframes applicable to many of our activities are mandated by legislation. For other activities we conduct we self-impose target timeframes, to ensure that we perform our functions efficiently and in a timely manner. Target timeframes are subject to ongoing review.

2. Prescription medicines

27 September 2018

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 and target timeframes:

Application category Description Timeframe in working days
Category 1 An application to register a new prescription medicine (other than an additional trade name) or to make a variation to an existing medicine that involves the evaluation of clinical, pre?clinical or bio-equivalence data. For example, new chemical entities, extensions of indication and new routes of administration. Legislated timeframe: 40 working days for notification of whether the application has passed preliminary assessment and 255 working days for the completion of the evaluation and notification of the decision.
Note: the timeframes quoted above are statutory timeframes. The new priority review pathway (applicable to Category 1 applications only) has the same statutory timeframe as other Category 1 applications, but the target timeframe is 150 working days.

Category 2

(until 31 December 2017)

An application accompanied by two independent evaluation reports from comparable overseas regulators in whose jurisdiction the product is approved for the same indication. Legislated timeframe: 20 working days for notification of whether the application has passed preliminary assessment and 175 working days to notify the applicant of the decision.

Comparable Overseas Regulator (COR) report-based process

(from 1 January 2018)

An application accompanied by an un-redacted assessment report package from a comparable overseas regulator.

Legislated timeframe: 40 working days for notification of whether the application has passed preliminary assessment. The timeframe to notify the applicant of the decision depends on the COR pathway:

  • COR-A: 120 working days
  • COR-B: 175 working days
Category 3

An application to register or to vary the registration of a prescription medicine where the application does not require the support of clinical, pre?clinical or bio-equivalence data.

For example, broader changes to the product specifications, manufacturing and labelling or a change in trade name.

Legislated timeframe: 45 working days to notify the applicant of the decision.
Correction to, or completion of, a Register entry

An application to vary the registration of a prescription medicine to correct or complete information that was inadvertently recorded incorrectly or omitted from the Register entry.

For example, errors to product information, or quality-related documentation.

No legislated timeframe: TGA processes as soon as possible.
Safety-related request (SRR)

An application to vary the registration of a prescription medicine to either:

  • reduce the patient population that can receive the medicine or
  • add a warning or precaution.
No legislated timeframe: TGA processes as soon as possible.
Notification request to vary an ARTG entry

An application to vary the registration of a prescription medicine, where the application has been determined to pose a very low risk under certain conditions.

For example, the removal of a redundant manufacture site.

No legislated timeframe: automatic approval on submission of e-form and full payment of fee.
Self-assessable request (SAR)

An application to register or to vary the registration of a prescription medicine where the application

  • does not require the support of clinical, pre-clinical or bio-equivalence data and
  • where no data are necessary or where the data can be self-assessed by the applicant.

For example, certain changes to the pack size or approved product label.

Legislated timeframe: 45 working days for notification of acceptance or rejection of an application, completion of evaluation and notification of the decision.
Additional Trade Name An application for an additional trade name for a registered prescription medicine. Legislated timeframe: 45 working days.

2.1. Approval times

Table 1 Prescription medicine application approval time for July 2017 to June 2018
  Approval time
(TGA working days)
Application type Submissions approved Legislated timeframe Mean Median Range
Category 1
A: New chemical entity/New biological entity/Biosimilar[a] 41 255 205 209 104-245
B: New fixed-dose combination 5 255 202 192 169-236
C: Extension of indicationa 53 255 185 193 85-242
D: New generic medicine 104 255 182 174 115-254
F: Major variation 42 255 192 196 130-254
G: Minor variation 1 255 250 250 250
H: Minor variation 6 255 162 164 145-171
J: Changes to Product Information requiring the evaluation of data 84 255 143 148 5-242
Additional trade name
E: Additional trade name (ATN) 69 45 26 27 4-43

Footnotes


Table 2 Prescription medicine median approval time comparisons
  Median approval time
(TGA working days)
Application type Legislated timeframe 2016-17 2017-18
Category 1
A: New chemical entity/New biological entity/Biosimilar 255 208 209
B: New fixed-dose combination 255 203 192
C: Extension of indication 255 202 193
D: New generic medicine 255 172 174
F: Major variation 255 185 196
G: Minor variation 255 0 250
H: Minor variation 255 143 164
J: Changes to Product Information requiring the evaluation of data 255 140 148
Additional trade name (ATN)
E: Additional trade name (ATN) 45 36 27
Minor Variations
Category 3
G: Minor variation[a] 45 26 39
H: Minor variation[b] 45 23 32
Safety-related request [(SRR)] n/a 21 32
Self-assessable request [(SAR)] 45 14 33
Minor editorial change [(MEC)] 45 20 26
Correction [9D(1)] n/a 62 56

Footnotes


Figure 1 Submissions received 2016-17 and 2017-18
bar chart - see tabular format below
Figure 1 Submissions received 2016-17 and 2017-18
Application type Jul 16 - Jun 17 Jul 17 - Jun 18
New chemical entity/New biological entity/Biosimilar 43 39
Extension of indication 56 58
New generic medicine 100 91
Figure 2 Mean approval times 2016-17 and 2017-18
bar chart - see tabular format below
Figure 2 Mean approval times 2016-17 and 2017-18
Application type Jul 16 - Jun 17 Jul 17 - Jun 18
New chemical entity/New biological entity/Biosimilar 220 205
Extension of indication 198 185
New generic medicine 182 184
Figure 3 Median approval times 2016-17 and 2017-18
bar chart - see tabular format below
Figure 3 Median approval times 2016-17 and 2017-18
Application type Jul 16 - Jun 17 Jul 17 - Jun 18
New chemical entity/New biological entity/Biosimilar 208 209
Extension of indication 202 192
New generic medicine 172 175

2.2. Submission outcomes

Table 3 Number of completed prescription medicine submissions by type and outcome for July 2017 to June 2018
Submission Type Approved Withdrawn Rejected Total
A: New chemical entity/New biological entity/Biosimilar 41 5 0 46
B: New fixed-dose combination 5 0 0 5
C: Extension of indication 53 2 1 56
D: New generic medicine 104 10 2 116
E: Additional Trade Name 69 2 0 71
F: Major variation 42 0 0 42
G: Minor variation (Category 1) 1 0 0 1
G: Minor variation (Category 3) 115 2 1 118
H: Minor variation (Category 1) 6 0 0 6
H: Minor variation (Category 3) 1,311 21 0 1,332
J: Changes to Product Information 84 1 0 85
Safety-related request [K(SRR)] 658 9 0 667
Self-assessable request [H(SAR)] 967 18 0 985
Minor editorial change [K(MEC)] 171 6 0 177
Correction [H9D(1)] 71 8 0 79
Notification [Y] 732 2 0 734
Total 4,430 86 4 4,520

2.3. Other applications

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 seek approval to supply a product when it doesn't meet a particular standard.

Table 4 Number of other prescription medicine applications
  2016-17 2017-18
July to June
Exemptions to comply with a standard [N(S14)]
Approved 89 67
Rejected 1 0
Total (excluding withdrawals) 90[a] 67

Footnotes


2.4. Orphan drug designations

Reporting on orphan drugs for 2017-18 reflects those submitted through the new program which applies to orphan drug designation applications lodged from 1 July 2017, as well as those submitted under the previous program but approved after the new program came into effect. The eligibility criteria for the previous orphan drug program applied to all applications submitted prior to 1 July 2017, regardless of the designation approval date.

A prescription medicine must have a valid orphan drug designation to be eligible for a waiver of application and evaluation fees.

Table 5 Number of orphan drug designations
  2016-17[a] 2017-18
July to June
Number of designations approved under the previous orphan drug program (designation application received prior to 1 July 2017) 29 5
Number of designations approved under current orphan drug program (designation application received from 1 July 2017) 0 11
Total 29 16

Footnotes


Table 6 Number of orphan drug registrations
  2016-17 2017-18[a]
July to June
Application Type Number Approved Median approval time (TGA working days) Number Approved Median approval time (TGA working days)
A: New chemical entity/New biological entity/Biosimilar 9 210 9 213
C: Extension of Indications 5 185 10 198
F: Major Variation 1 134 2 185
Total 15 196 21[b] 197

Footnotes


Orphan drug registrations and approval times quoted in Table 6 are also included in the total number of applications reported in each respective application category in the tables and figures above.

2.5 Priority review pathway

A prescription medicine must have a valid priority review determination before it can be evaluated for registration under the priority review pathway. The determination process is used to assess whether a medicine is eligible for the priority pathway but does not necessarily mean that the medicine will be approved after evaluation and registered on the ARTG.

Table 7 Priority review determinations granted from July 2017 to June 2018
Priority review determinations approved
Application type (proposed) Approved
A: New chemical entity/New biological entity/Fixed dose combination 4
C: Extension of Indications 10
Total 14
Table 8 Medicines approved through the priority review pathway[a] between July 2017 and June 2018
Priority Review Registration Approvals
Application Type Number approved Median approval time
(TGA working days)
A: New chemical entity/New biological entity/Fixed dose combination 1 104
C: Extension of Indications 4 97
Total 5 98

Footnotes


Priority review registrations and approval times quoted in Table 8 are also included in the total number of applications reported in each respective application category in the tables and figures above.

2.6 Provisional approval pathway

A prescription medicine must have a valid provisional determination before it can be evaluated for registration under the provisional approval pathway. The determination process is used to assess whether a medicine is eligible for the provisional pathway but does not necessarily mean that the medicine will be approved after evaluation and provisionally registered on the ARTG.

Table 9 Provisional determinations granted from March 2018 to June 2018
Provisional determinations approved[a]
Application type (proposed) Approved
A: New chemical entity/New biological entity/Fixed dose combination 1
C: Extension of Indications 1
Total 2

Footnotes


3. Over-the-counter medicines

27 September 2018

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. The following target timeframes apply to OTC medicine applications:

Table 10 Categorisation of OTC medicine applications
Application category Definition Timeframe in days
N1 An application submitted as a 'Clone'. 45 working days
N2 An application which complies with an OTC medicine monograph. 55 working days
N3 New application for a 'generic' medicine other than those 'generic' applications in levels N1, N2 or N4. 150 working days
N4

An application for a 'generic' medicine where the medicine:

  • requires supporting safety and/or efficacy (clinical/toxicological) data or a justification for not providing such data; and/or
  • requires a higher level of assessment due to the umbrella branding segment of the product name; and/or
  • has not been previously registered as an OTC medicine following down-scheduling.
170 working days
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. 210 working days
CN

'Notification' changes, where their implementation would not impact the quality, safety or efficacy of a medicine. Includes quality and non-quality changes classified as 'negligible risk'.

- Implemented 1 July 2017

N/A

(Automated validation and approval)

C1 Quality and non-quality changes classified as 'negligible risk'. 20 working days
C2 Quality and non-quality changes classified as 'low risk' - no safety and/or efficacy data required; quality data may be required. 64 working days
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.

120 working days
C4 Non-quality changes classified as 'moderate risk' - safety and/or efficacy data required unless justified. 170 working days
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. 20 working days
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. 120 working days
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. N/A

3.1 Approval times

We aim to have 80% of applications completed within target timeframes.

Table 11 Median approval time for OTC medicine applications
  2016-17 2017-18
July to June
New medicine applications (days)
N1 27 25
N2 43 35
N3 94 74
N4 106 55
N5 192 162
Change applications (days)
C1 7 4
C2 14 31
C3 14 72
C4 86 95
Table 12 OTC medicine approval time against target time by application category for July 2017 to June 2018
Application type Number completed Range Mean Median % within target
New medicines
N1 144 1-54 25 25 96
N2 5 34-39 36 35 100
N3 37 31-184 82 74 97
N4 19 49-204 85 55 95
N5 8 152-185 167 162 100
Change applications
C1 202 0-26 6 4 99
C2 386 0-70 29 31 99
C3 5 12-124 60 72 80
C4 4 46-159 99 95 100
Table 13 Percentage of OTC medicine applications processed within target time
  2016-17 2017-18
July to June
New medicine applications (%)
N1 100 96
N2 100 100
N3 100 97
N4 100 95
N5 100 100
Change applications (%)
C1 97 99
C2 99.6 99
C3 100 80
C4 100 100

3.2 Applications

3.2.1 New OTC medicine applications

Table 14 Applications received for new OTC medicines and changes to existing medicines
  2016-17 2017-18
July to June
New medicine applications
N1 108 169
N2 5 16
N3 44 64
N4 23 23
N5 6 8
Total 186 280
Change applications
CN - 171
C1 387 190
C2 276 438
C3 7 7
C4 2 3
Total 672 809

3.2.2 Completed applications

Table 15 New OTC medicine applications completed and outcomes
  2016-17 2017-18
July to June
N1
Approved 93 144
Rejected 0 0
Withdrawn by sponsor 1 7
Returned/failed screening 0 0
Total 94 151
N2
Approved 7 5
Rejected 0 0
Withdrawn by sponsor 1 6
Returned/failed screening 0 0
Total 8 11
N3
Approved 29 37
Rejected 0 0
Withdrawn by sponsor 2 1
Returned/failed screening 3 8
Total 34 46
N4
Approved 29 19
Rejected 0 1
Withdrawn by sponsor 0 3
Returned/failed screening 6 2
Total 35 25
N5
Approved 8 8
Rejected 0 0
Withdrawn by sponsor 0 2
Returned/failed screening 0 1
Total 8 11
Table 16 OTC change applications completed and outcomes
  2016-17 2017-18
July to June
C1
Approved 396 202
Rejected 0 0
Withdrawn by sponsor 10 2
Returned/failed screening 0 0
Total 406 204
C2
Approved 226 386
Rejected 0 0
Withdrawn by sponsor 7 11
Returned/failed screening 1 2
Total 234 399
C3
Approved 7 5
Rejected 0 0
Withdrawn by sponsor 1 0
Returned/failed screening 2 1
Total 10 6
C4
Approved 1 4
Rejected 0 0
Withdrawn by sponsor 0 0
Returned/failed screening 0 0
Total 1 4

3.2.3 Other applications

Other application types that we process include requests for advice for the purpose of listing a medicine as a pharmaceutical benefit. 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.

Table 17 Number of other OTC medicine applications
  2016-17 2017-18
July to June
Requests for advice for the purpose of listing a medicine as a pharmaceutical benefit
B1 1 0
B3 1 0
Total 2 0
Requests for consent under section 14/14A of the Act to import, export or supply therapeutic goods not complying with an applicable standard
Approved 25 10
Rejected 1 0
Total 26 10

4. Registered complementary medicines

27 September 2018

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 safety, efficacy, performance and quality prior to being registered on the ARTG.

Table 18 Registered complementary medicine applications by outcome
  2016-17 2017-18
July to June
New medicines
Approved 6 5
Rejected 1 1
Withdrawn 3 0
Returned/failed screening 0 0
Total new applications completed 10 6
Variations
Approved 20 19
Rejected 1 4
Withdrawn 3 0
Returned/failed screening 0 0
Total variations completed 24 23
Application for consent to import, supply or export goods under section 14/14A of the Act[a]
Approved 1 12
Rejected 0 0
Total applications completed 1 12

Footnotes


5. Listed medicines

27 September 2018

5.1. New ingredients permitted for use in listed medicines

Table 19 New listed medicine ingredient applications by outcome
  2016-17 2017-18
July to June
Application outcome
Approved 79 24[a]
Rejected 0 0
Withdrawn 1 3
Returned/failed screening 0 1
Total completed 80 28

Footnotes


5.2. New listed medicines

Table 20 New listed medicines
  2016-17 2017-18
July to June
New listed medicines 1,581 1,792

Table 21 Listed medicine variations under section 9D of the Therapeutic Goods Act 1989

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 21 Listed medicine variations under section 9D of the Therapeutic Goods Act 1989
  2016-17 2017-18
July to June
Medicine variation
Approved 85 91
Rejected 4 5
Total 89 96
Table 22 Listed medicine applications under section 14/14A of the Therapeutic Goods Act 1989
  2016-17 2017-18
July to June
Application
Exemption granted[a] 7 5
Rejected 2 0
Total 9 5

Footnotes


5.2.1 Investigations

Investigations include 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 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 23 Listed medicine investigations undertaken and outcomes
  2016-17[a] 2017-18
July to June
Initiated investigations 80 56
Completed investigations
Medicines prioritised for targeted review 60 50
Referred to another TGA area or government organisation 3 4
No further action taken[b] 21 10
Total completed investigations 84 64

Footnotes


5.2.2 Compliance reviews

Listed medicines are not 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 24 Listed medicine reviews by type
  2016-17 2017-18
July to June
Initiated reviews
Targeted reviews 504 82
Random reviews 87 143
Total 591 225
Reviews on hand 189 173
Completed reviews
Targeted reviews 421 162
Random reviews 130 81
Total 551 243
Table 25 Completed listed medicine reviews by outcome
  2016-17 2017-18
July to June
Compliance status determined
Medicines with no compliance breaches 87 42
Medicines with verified compliance breaches 330 129
Sub-total 417 171
Compliance status unable to be determined
Medicines cancelled by sponsors after request for information 74 51
Medicines not yet manufactured 58 13
Other 1 5
Sub-total 133 69
Product not a therapeutic good 1 3
Total completed 551 243
Figure 4 Outcomes of compliance reviews by reason for initiation[a]
Doughnut chart - see text version below

Footnotes


Doughnut chart

Inner circle
  • Compliance status determined: 71%
  • Compliance status unable to be determined: 29%
Middle circle
  • No compliance breaches: 25%
  • Verified compliance breaches: 75%
  • Cancelled by sponsor after request for information: 74%
  • Not manufactured: 19%
  • Other: 7%
Outer circle
  • No compliance breaches
    • Random review: 17%
    • Targeted review: 83%
  • Verified compliances breaches
    • Random review: 38%
    • Targeted review: 62%
  • Cancelled by sponsor after request for information
    • Random review: 33%
    • Targeted review: 67%
  • Not manufactured
    • Random review: 54%
    • Targeted review: 46%
  • Other
    • Random review: 20%
    • Targeted review: 80%

Table 26 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 identified.

Table 26 Types of listed medicine compliance issues identified
  2016-17 2017-18
July to June
Type of compliance issue
Information provided in ARTG entry 119 69
Manufacturing, quality and/or formulation 62 27
Labelling 94 58
Advertising 86 59
Unacceptable presentation 140 63
Evidence[a] 180 50
Safety[b] 22 0
Non-response to a request for informationc 8 5
Other[c] 4 2

Footnotes


Figure 5[a] Types of compliance issues identified by reason for initiation
Two pie charts: Random reviews and Targeted reviews - see tabular version below

Footnotes


Figure 5 Types of compliance issues identified by reason for initiation
Compliance issue Random reviews Targeted reviews
Evidence 21% 7%
Unacceptable presentation 19% 16%
Advertising code 16% 17%
Labelling 23% 23%
Quality 7% 7%
ARTG information[d] 10% 10%
Safety 0% 0%
Non-response to RFI[b] 1% 2%
Other[c] 1% 1%
Table 27 Actions taken following listed medicine reviews
  2016-17 2017-18
July to June
Actions following a Request for Information
Medicines found to be compliant and review concluded 87 42
Medicines cancelled by the TGA without a proposal to cancel notice 0 0
Proposal to cancel notice or warning[a] sent by the TGA 330 129
Total 417 171
Actions following Proposal to Cancel notice[b]
Medicines cancelled by the TGA 17 10
Medicines cancelled by sponsors after being notified of compliance breaches 84 45
Reviews concluded after compliance breaches were addressed 229 74
Total 330 129

Footnotes


Figure 6[a] Outcomes of completed compliance reviews
pie chart - see tabular version below

Footnotes


Figure 6 Outcomes of completed compliance reviews
Outcome Percent
Compliant after Proposal to Cancel or warning 63%
Cancelled by the sponsor after Proposal to Cancel or warning 20%
Compliant 12%
Cancelled by TGA after Proposal to Cancel or warning 5%

6. Biologicals and blood components

27 September 2018

6.1. Inclusion of biologicals

Table 28 Applications for biologicals[a] received and on hand
  2016-17 2017-18
July to June
Applications received
Technical Master File (TMF)[b] new 0 0
TMF annual updates 5 3
TMF variations 20 14
TMF notifications 27 8
Plasma Master File[c] annual updates 11 10
Biological Class 2 - new applications 4 1
Biological Class 3 - new applications 0 0
Biological Class 4 - new applications 0 2
Biological Class 2 - variations 14 22
Biological Class 3 - variations 1 5
Total received 82 65
Applications on hand
TMF new 1 0
TMF annual updates 4 2
TMF variations 7 4
TMF notifications 0 0
Plasma Master File annual updates 4 7
Biological Class 2 - new applications 6 2
Biological Class 3 - new applications 3 1
Biological Class 4 - new applications 0 2
Biological Class 2 - variations 2 3
Biological Class 3 - variations 0 0
Total on hand 27 21

Footnotes


Table 29 Completed applications for biologicals
  2016-17 2017-18
July to June
Biologicals applications
Technical Master File (TMF) new 1 1
TMF annual updates 5 2
TMF variations 19 8
TMF notifications 27 8
Plasma Master File annual updates 7 8
Biological Class 2 - new applications 1 3
Biological Class 3 - new applications 1 0
Biological Class 4 - new applications 0 0
Biological Class 2 - variations 18 22
Biological Class 3 - variations 2 5
Total completed 81 57

7. Medicine and vaccine adverse event reports

27 September 2018

7.1. Adverse medicine and vaccine reaction notifications

Table 30 Source of notifications of medicine and vaccine adverse reactions[a]
  2016-17 2017-18
July to June
Reports with clear causality by reporter
Hospitals 1,850 1,952
Companies 9,194 11,333
General practitioners 573 875
Specialists 245 224
Pharmacists 1,063 975
Members of the public 1,104 1,170
Nurses, dentists, complementary healthcare practitioners 157 260
State/Territory Health departments 3,274 3,459
Reports withdrawn, or rejected, or without clear causality
2,276 1,370
Total received 19,736 21,618
Mean number of reports received weekly 380 416
Vaccine reports included in this table 4,020 4,327

Footnotes


8. Medical devices

27 September 2018

The Medical Devices Regulatory Framework spans the life cycle for these products, including:

  • Conformity assessment: Is the systematic examination by the manufacturer to determine that a medical device is safe and performs as intended and, therefore, conforms to the Essential Principles. Certification of the manufacturer's conformity assessment procedure may (and in some cases must) be undertaken by the TGA, or we may recognise conformity assessment certification from European notified bodies.
  • Inclusion on the ARTG: Medical devices cannot be imported, supplied in, or exported from Australia unless they are included on the ARTG or a valid exemption applies, for example custom made medical devices, importation of samples, etc. A sponsor can apply to include a medical device on the ARTG if the device complies with the Essential Principles and appropriate conformity assessment procedures have been applied to the device (typically demonstrated through conformity assessment certification).
  • Post-market monitoring: Once a medical device has been included on the ARTG the device must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval.
  • Priority review of medical devices: A new pathway has been developed to allow faster processing of applications for devices that meet certain criteria for novelty and health benefits. The TGA is yet to receive an application for priority review.
  • Medical device manufacturing: The TGA assesses the quality management systems of medical device manufacturers seeking TGA conformity assessment certification. This may be through onsite inspections or desktop assessment of third party inspection reports, or a combination of these methods. Surveillance inspections are also undertaken to assess continuing compliance. In addition, the TGA is a Regulatory Authority of the Medical Devices Single Audit Program (MDSAP) that assesses and recognises third party Auditing Organisations for the purposes of certifying medical device manufacturers.

8.1. Conformity assessment

8.1.1 Applications

Table 31 Number of conformity assessment applications (medical devices including IVDs)
  2016-17 2017-18
July to June
Conformity assessment applications
Applications received 242 309
Applications on hand 213 251
Applications completed 204 273

8.1.2 Outcomes

Table 32[a] Outcomes of conformity assessment applications
  2016-17 2017-18
July to June
New
Approved 37 58
Rejected 1 1
Withdrawn/ Lapsed 20 35
Variation (changes and re-certifications)
Approved 124 166
Rejected 2 1
Withdrawn/ Lapsed 20 12
Total 204 273

Footnotes


8.1.3 Processing timeframes

We are required to complete conformity assessment applications within 255 working days.

Table 33 TGA processing times for new devices and variations
  2016-17 2017-18
July to June
New devices
Mean TGA processing time (days) 129 131
Median TGA processing time (days) 167 189
Variations (changes and recertifications)
Mean TGA processing time (days) 114 110
Median TGA processing time (days) 101 95

8.2 Inclusion of medical devices (including IVDs)

8.2.1 Applications

Table 34 Applications for inclusion - medical devices (including IVDs)
  2016-17 2017-18
July to June
Class I medical devices[a]
Applications received 2,514 4,805
Applications completed 2,431 4,804
Class I measuring medical devices
Applications received 51 62
Applications completed 50 64
Applications on hand[b] 4 5
Class I sterile medical devices
Applications received 246 255
Applications completed 255 240
Applications on hand[b] 3 7
Class IIa medical devices
Applications received 1,160 1,219
Applications completed 1,178 1,191
Applications on hand[b] 51 92
Class IIb medical devices
Applications received 666 650
Applications completed 682 568
Applications on hand[b] 34 132
Class III medical devices
Applications received 343 406
Applications completed 471 378
Applications on hand[b] 180 208
Class III Joint Reclassification medical devices
Applications received 0 0
Applications completed 203 88
Applications on hand[b] 94 5
Active Implantable Medical Devices (AIMD)
Applications received 48 24
Applications completed 87 34
Applications on hand[b] 23 10
Class 1 IVDs[c]
Applications received 94 74
Applications completed 91 76
Applications on hand[b] 4 2
Class 2 IVDs
Applications received 96 81
Applications completed 94 80
Applications on hand[b] 12 13
Class 3 IVDs
Applications received 49 58
Applications completed 45 60
Applications on hand[b] 15 14
Class 4 IVDs
Applications received 15 27
Applications completed 15 27
Applications on hand[b] 0 1

Footnotes


8.2.2 Outcomes

Class I automatically included medical devices are not counted in the outcomes for inclusion applications as these applications cannot be rejected.

Table 35 Outcomes of medical device applications by classification
  Number of applications
2016-17 2017-18
Device Classification Approved/ Accepted Rejected/ Lapsed Withdrawn Approved/ Accepted Rejected/ Lapsed Withdrawn
Class I 2,431 0 0 4,804 0 0
Class I Measurement 44 2 4 60 0 4
Class I Sterile 248 0 7 222 0 18
Class IIa 1,128 6 44 1,138 7 46
Class IIb 659 3 20 513 9 46
Class III 398 18 55 306 17 55
Class III Reclassification 152 3 48 59 15 14
AIMD 87 0 0 33 0 1
Class 1 IVD 84 0 7 73 0 3
Class 2 IVD 71 2 21 75 0 5
Class 3 IVD 37 0 8 58 0 2
Class 4 IVD 14 0 1 27 0 0

8.2.3 Processing times

The target timeframe 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').

Table 36 Processing times for medical device application audits (including IVDs)
  2016-17 2017-18
Number of applications Sponsor days TGA days[a] Number of applications Sponsor days[b][d] TGA days[a][d]
Mean Processing Time
Medical devices
Applications completed without audit 2,105     2,021    
Non-compulsory audit[c] 310 42 55 197 58 58
Level 1 compulsory audit 40 25 18 27 23 33
Level 2 compulsory audit 471 74 159 318 79 83
IVDs
Applications completed without audit 77     115    
IVD non-compulsory audit 10 35 46 5 34 57
IVD compulsory audit 82 29 39 56 29 81
Median Processing Time
Medical devices
Applications completed without audit 2,105     2,021    
Non-compulsory audit[c] 310 27 24 197 33 24
Level 1 compulsory audit 40 23 13 27 22 23
Level 2 compulsory audit 471 60 155 318 54 47
IVDs
Applications completed without audit 77     115    
IVD non-compulsory audit 10 22 36 5 21 23
IVD compulsory audit 82 18 29 56 24 64

Footnotes


8.3. Post-market monitoring

8.3.1 Compliance reviews

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.

Table 37 Restricted word Class 1 medical device and targeted compliance reviews
  2016-17 2017-18[b]
July to June
Restricted word reviews
Reviews completed 54 122
Reviews commenced 55 122
Reviews on hand 1 9
Targeted compliance reviews[a]
Reviews completed 35 166
Reviews commenced 45 211
Reviews on hand 175 229

Footnotes


8.3.2 Post-market reviews

Table 38 Medical device targeted reviews
  2016-17 2017-18
July to June
Post market reviews
Reviews commenced - number of ARTG entries 396 620
Reviews completed - number of ARTG entries 239 568
Reviews on hand - number of ARTG entries 263 315

8.3.3 Medical device incident reports

A medical device incident is an event associated with the use or misuse of a medical device that resulted in, or could have resulted in (near-incident), serious injury, illness or death to patient, healthcare worker or other person. Australian sponsors of medical devices must actively monitor their devices' post market performance and report incidents to the TGA. Reporting of incidents, or near-incidents, by users is voluntary. The TGA promotes and encourages users to report but cannot enforce reporting by users.

The target timeframe for processing medical device incident reports is 90 working days.

Table 39 Number of medical device incident reports and processing times
  2016-17 2017-18
July to June
Device incident reports
Reports received 4,896 5,348
Reports completed 4,918 4,653
Reports still in progress 380 283
Processing time
Mean TGA processing time (days) 1 1
Median TGA processing time (days) 10 6
Percentage processed within target timeframe 95% 98%
Table 40 Medical device incident report outcomes[a]
  2016-17 2017-18
July to June
Incident report outcome
Reviewed and used for trend analysis purposes 4,125 4,713
Reviewed, no further action required 279 252
Product recall 70 27
Recall for product correction 4 57
Hazard alert 22 41
Product notification 0 0
Safety alert 20 2
Product enhancement/improvement notice 1 0
Instructions for use amended 5 6
Referral for post-market review 82 139
Refer to another TGA Branch 39 51
Company warned 13 9
Product suspended from ARTG 0 0
Product cancelled from ARTG 1 2
Manufacturing process improvements 12 10
Quality system process improvements 0 2
Maintenance carried out by the hospital 0 0
Change to design 3 4
Not device related 16 3
Other 81 403

Footnotes


8.3.4 Devices manufacturing

Table 41 Outcomes of Quality Management System (QMS) audits of Australian manufacturers
  2016-17 2017-18
July to June
QMS audits (Australia)
Number of audits conducted 38 41
Satisfactory compliance (of completed audits) 71% 92%
Marginal compliance (of completed audits) 24% 8%
Unacceptable (of completed audits) 0% 0%
Close-out in Progress 5% 37%
Processing time
Initial audits conducted within 3 months of application 57% 83%
Re-audits conducted within 6 months of due date 16% 46%
Table 42 Outcomes of QMS audits of overseas manufacturers
  2016-17 2017-18
July to June
QMS audits (overseas)
Number of audits conducted 26 30
Satisfactory compliance (of completed audits) 92% 100%
Marginal compliance (of completed audits) 0% 0%
Unacceptable (of completed audits) 0% 0%
Close-out in Progress 8% 60%
Processing time
Initial certification audits conducted within 6 months of application 80% 72%
Certification re-audits conducted within 6 months of due date 9% 42%
Table 43 Outcomes of MDSAP Program
  2016-17 2017-18
July to June
MDSAP Assessments (overseas)
Number of auditing organisation assessments 5 8
Number of witnessed manufacturing audits 4 5

9. Exports

27 September 2018

9.1. Export only medicines

The target timeframe for processing of export only medicine applications and variations is 31 working days.

Table 44 Approval times for export only medicines
  2016-17 2017-18
July to June
New applications
Mean TGA processing time (days) 25 25
Median TGA processing time (days) 26 26
Percentage processed within target processing time 75% 70%
Variations
Mean TGA processing time (days) 22 19
Median TGA processing time (days) 22 23
Percentage processed within target processing time 89% 91%
Table 45 Applications for new and variations to export only medicines
  2016-17 2017-18
July to June
Export only applications
Applications received 242 254
Applications awaiting response from sponsor 9 14
Applications completed
Approved 207 237
Withdrawn 17 19
Total completed 224 256

9.2. Export certifications for medicines

The target processing time for applications for an export certificate for a medicine is 15 working days.

Table 46 Export certification applications and processing times
  2016-17 2017-18
July to June
Applications received 1,582 1,799
Applications completed
Approved 1,413 1,849
Withdrawn 3 30
Total completed 1,416 1,819
Processing times
Mean TGA processing time (days) 12 14
Median TGA processing time (days) 13 13
Percentage processed within target time 99% 69%

9.3. Export certification assessment for medical devices

The target processing time for applications for an export certificate for a medical device is 10 working days.

Table 47 Medical device applications and processing times for export certification assessments
  2016-17 2017-18
July to June
Applications received 553 625
Applications completed
Export certificates issued 504 617
Applications withdrawn 10 4
Total completed 514 621
Processing time
Mean TGA processing time (days) 4.5 8
Median TGA processing time (days) 4 6
Percentage processed within target time 83% 80%

9.4. Blood permits for export

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
Bar chart - see tabular version below
Figure 7 Number of blood permits processed
Permit type Jul 16 - Jun 17 Jul 17 - Jun 18
Bone and tissues 46 79
Blood and fractions 104 128
Annual blood permits 46 25

10. Access to unapproved therapeutic goods

27 September 2018

10.1. Special Access Scheme

The Special Access Scheme (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, three pathways existed under the scheme (two pre-existing and one newly added pathway) and they are categorised as follows:

  • Category A is a notification pathway which can only be accessed by medical practitioners for patients who are seriously ill with a condition from which death is reasonably likely to occur within a matter of months, or from which premature death is reasonably likely to occur in the absence of early treatment.
  • Category B is an application pathway which can be accessed by health practitioners for patients that do not fit the Category A definition. An approval letter from TGA is required before the goods may be accessed.
  • Category C is a notification pathway which allows health practitioners to supply goods that are deemed to have an established history of use without first seeking prior approval. The goods deemed to have an established history of use are specified in a list along with their indications and the type of health practitioner authorised to supply these products.

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.

Table 48 SAS medicine notifications and applications
  2016-17 2017-18
July to June
Category A notifications
Total Category A notifications 46,678 36,881
Category B applications
Approved 21,609 11,641
Cancelled 355 40
Rejected 21 28
Pending at end of reporting period 418 370
Total Category B applications 22,403 12,079
Category C notifications
Total Category C notifications N/A 14,560
Total SAS notifications/applications received (all categories) 69,081 63,250
Table 49 SAS device notifications and applications
  2016-17 2017-18
July to June
Category A notifications
Total Category A notifications 4,914 4,511
Category B applications
Approved 2,113 2,466
Cancelled 96 15
Rejected 1 9
Pending at end of reporting period 135 143
Total Category B applications 2,345 2,633
Category C notifications
Total Category C notifications N/A 177
Total SAS notifications/applications received (all categories) 7,259 7,321
Table 50 SAS biological notifications and applications
  2016-17 2017-18
July to June
Category A notifications
Total Category A notifications 47 110
Category B applications
Approved 2,024 711[a]
Cancelled 89 8
Rejected 0 0
Pending at end of reporting period 44 9
Total Category B applications 2,157 728
Category C notifications
Total Category C notifications N/A 802
Total SAS notifications/applications received (all categories) 2,204 1,640

Footnotes


10.2. Clinical trials

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.

Table 51 Number of notifications for new clinical trials involving unapproved therapeutic goods received by therapeutic good type
  2016-17 2017-18
July to June
Therapeutic good type
Medicine 409 436
Device[a] 152 143
Biological 10 7
Medicine and device 290 325
Device and biological 1 1
Medicine and biological 6 5
Medicine, device and biological 0 3
Total 868 920

Footnotes


Table 52 Number of new clinical trial notifications involving unapproved therapeutic goods received by phase
  2016-17 2017-18
July to June
Clinical trial type
Phase 1 191 262
Phase 2 189 209
Phase 3 257 246
Phase 4 89 65
Device 118 125
Bioavailability/equivalence 24 13
Total 868 920
Table 53 Number of notifications for new clinical trials and variations to previously notified clinical trials, including non-fee attracting variations, involving unapproved therapeutic goods received by therapeutic good type
  2016-17 2017-18
July to June
Therapeutic good type
Medicine 1,230 1,154
Device[a] 266 240
Biological 12 12
Medicine and device 1,417 1,557
Device and biological 2 5
Medicine and biological 10 11
Medicine, device and biological 1 4
Total 2,938 2,983

Footnotes


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.

Table 54 Number of new clinical trials and variations[a] to previously notified clinical trials involving unapproved therapeutic goods received by phase
  2016-17 2017-18
July to June
Phases
Phase 1 459 612
Phase 2 648 707
Phase 3 1,358 1,280
Phase 4 246 165
Device 194 195
Bioavailability/equivalence 33 24
Total 2,938 2,983

Footnotes


10.3. Authorised Prescribers

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.

Table 55 Authorised Prescriber approvals for medicines, medical devices and biologicals
  2016-17 2017-18
July to June
Approvals by therapeutic good type
Number of approvals for medicines 764 605
Number of approvals for medical devices 304 407
Number of approvals for biologicals 1 0
Total 1,069 1,012

11. Medicines and biologicals manufacturing

27 September 2018

11.1. Manufacturing licences issued to Australian manufacturers

Table 56 Status of manufacturing licence applications
  2016-17 2017-18
July to June
Licence status (Australia)
New licences granted 9 23
Withdrawn application 10 5
Revoked licences - at request of licence holder 19 19
Revoked licences - TGA 1 2
Suspended - at request of licence holder 1 2
Suspended - TGA 0 0

As at 30 June 2018, there were 248 Australian companies holding manufacturing licences covering 393 sites.

Table 57 Outcomes of inspections of Australian manufacturers[a]
  2016-17 2017-18
July to June
Inspection status (Australia)
Number of inspections conducted 185 210
Satisfactory compliance (of completed inspections)[b] 88% 85%
Marginal compliance (of completed inspections)[c] 10% 10%
Unacceptable (of completed inspections) 2% 5%
Close-out in progress 18% 9%
Processing time
Initial inspections conducted within 3 months of application 85% 96%
Re-inspections conducted within 6 months of due date 61% 72%

Footnotes


11.2. Approval (certification) of overseas manufacturers

Table 58[a] Manufacturing certification application by status (overseas)
  2016-17 2017-18
July to June
Applications (overseas)
New applications received 46 33
Re-inspection applications 38 55[a]
Applications completed
Certified 33 85[a]
Rejected[b] 59 51
Total completed 92 136

Footnotes

As at 30 June 2018, there were 208 overseas manufacturers covering 211 manufacturing sites that were subject to TGA inspection and approximately 2,700 overseas manufacturing sites that relied on evidence from recognised regulators.


Table 59 Outcomes of inspections of overseas manufacturers[a]
  2016-17 2017-18
July to June
Inspection status (overseas)
Number of inspections conducted 58 84
Satisfactory compliance (of completed inspections)[b] 94% 86%
Marginal compliance (of completed inspections)[c] 6% 11%
Unacceptable (of completed inspections) 0% 3%
Close-out in progress 10% 12%
Processing time
Initial certification inspections conducted within 6 months of application 64% 68%
Certification re-inspections conducted within 6 months of due date 66% 66%

Footnotes


11.3. Good Manufacturing Practice clearances

GMP clearance is required by an Australian Sponsor when a step in manufacture of a medicine or Active Pharmaceutical Ingredient (API) is manufactured overseas and the manufacturing step is recorded on the ARTG.

Table 60 GMP clearance application status
  2016-17 2017-18
July to June
Applications received 5,471[a] 5,327
Applications completed
Approved 5,067 5,041
Rejected 642 344
Total completed 5,709 5,385

Footnotes


12. Recalls

27 September 2018

12.1. Medicine recalls

Table 61 Medicine recalls by reason for recall
  2016-17 2017-18
July to June
Reason for recall
Adverse reactions 1 1
Foreign matter 3 5
Illegal supply 0 2
Impurity and degradation 3 1
Labelling and packaging 7 8
Micro-organisms 2 1
pH 0 0
Potency 3 3
Sterility 0 1
Other[a] 13 13
Total 32 35

Footnotes


12.2. Medical device recalls

Table 62 Medical device (including IVDs) recalls by reason for recall
  2016-17 2017-18
July to June
Reason for recall
Adverse incidents 7 3
Diagnostic inaccuracy 105 3
Electrical defect 28 41
Illegal supply 2 2
Labelling and packaging 89 14
Mechanical and physical defects 169 202
Software defects 109 97
Sterility 14 5
Other[a] 75 187
Total 598 554

Footnotes


12.3. Biological recalls

Table 63 Biological recalls
  2016-17 2017-18
July to June
Recalls to hospital level 2 25[a]

Footnotes


13. Laboratory testing

27 September 2018

We conduct post-market monitoring and compliance testing, investigations and reviews, as well as market authorisation assessment of therapeutic goods.

Our 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.

We continue to publish laboratory results through the Database of TGA Laboratory Testing Results[1]. Consumers and health professionals can identify 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 safety, efficacy, performance and quality of medicines and medical devices for Australian consumers.

On 8 September 2017 the Pacific Medicines Testing Program was launched. This is a joint program between the Department of Foreign Affairs and Trade and the Therapeutic Goods Administration. Under the Program the TGA Laboratories will test the quality of five medicines per Pacific Island Country per year (2017-2021). The focus of the Program is medicines for non-communicable diseases, such as high blood pressure and diabetes, as well as antibiotics and medicines purchased in high volumes.



Table 64 Samples and products tested by type of therapeutic good and percentage which failed
  2016-17 2017-18
July to June
Therapeutic good type
Prescription medicines Total 1,168 1,106
% fail 0.9 0.5
OTC medicines[a] Total 51 59
% fail 13.7 6.8
Complementary medicines[a] Total 87 266
% fail 13.8 10.2
Medical devices Total 168 99
% fail 31 41.4
External[b] Total 32 70
% fail 62.5 8.6
Pacific Medicines Testing Program Total N/A 21
% Fail N/A 14.3
Unregistered[c] Total 220 155
% fail 63.6 56.1
Total samples (excluding AHQ samples) 1,726 1,776
Total samples[d] 2,328 2,005
Percentage fail 14% 10%
Total number of products tested[e] 590 836

Footnotes


Table 65 Samples that failed laboratory testing by reason for July 2017 to June 2018
  Medical devices OTC medicines Prescription medicines Unregistered products Complementary medicines External Pacific Medicines Testing Program Total
Contamination 2 0 1 0 2 0 0 5
Formulation 0 1 0 86 14 5 3 109
Label and packaging deficiencies 23 0 3 1 8 0 0 35
Performance 13 0 0 0 2 0 0 15
Physical or mechanical properties 3 3 2 0 1 1 0 10
Unregistered 0 0 0 0 0 0 0 0
Total 41 4 6 87 27 6 3 174
Table 66 Batch release and export certification
  2016-17 2017-18
July to June
Batch releases and certifications
Batch release[a] 453 432
Export certification[b] 75 34

Footnotes


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.

Table 67 Target timeframes in working days for laboratory testing by priority and testing type
Priority of testing Biochemical/chemical testing Microbiological testing Medical device testing
Urgent[a] 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

Footnotes


Table 68 Compliance with testing timeframes[b] for July 2017 to June 2018
  Priority Total Percentage
Therapeutic good type[a]
Medical devices Routine 55 87.3
Priority 44 70.5
Urgent 0 N/A
OTC medicines Routine 54 33.3
Priority 5 80
Urgent 0 N/A
Prescription medicines Routine 225 43.6
Priority 24 100
Urgent 2 100
Complementary medicines[c] Routine 219 43.8
Priority 47 70.2
Urgent 0 N/A
Unregistered products Routine 1 100
Priority 149 84.6
Urgent 5 100

Footnotes


14. Regulatory compliance

27 September 2018

Our regulatory compliance and investigations area conducts compliance and enforcement activities against a risk based compliance framework. A range of tools are utilised to encourage compliance and address non-compliance including education and guidance, warnings, the issue of infringements, or product suspensions or cancellations. Investigations may also result in criminal or civil court proceedings. All compliance activities have the intended purpose of protecting public health.

Table 69 Regulatory compliance investigations by final action taken
  2016-17 2017-18
July to June
Investigations in progress 1,136 1,013
Completed investigations
Warned (including destruction) 1,973 2,173
No offence detected 110 226
Goods released under Personal Import Scheme 691 324
Referred to another agency or department outside Health 21 58
Referred to another branch within the TGA 13 28
Filed for intelligence purposes 45 161
Finalised in a linked file 25 5
Import treated as abandoned goods by Customs 8 5
Recall of goods 1 0
Matters referred to the Commonwealth Director of Public Prosecutions 0 2
Total completed 2,887 2,982
Units seized and destroyed at the point of importation[a] 884,081 850,514

Footnotes


Table 70 Types of products investigated[a]
  2016-17 2017-18
July to June
Therapeutic good type
Complementary medicines 599 294
Prescription medicines 4,367 5,214
Medical devices 166 131
Homoeopathic medicines 36 550
OTC medicines 54 71
Biological products 28 31
Other[b] 119 91
Total 5,369 6,382

Footnotes


Table 71 Regulatory compliance investigations by special interest categories
  2016-17 2017-18
July to June
Compliance investigation category
Unapproved product 4,855 6,497
Counterfeit product 326 218
Parallel import/export 28 1
Manufacture without licence 8 3
Traditional Chinese medicines 15 20
Other[a] 33 8
Total 5,265 6,747

Footnotes


Table 72 Location of alleged offence by referral type for July 2017 to June 2018
Origin ACT NSW NT QLD SA VIC WA TAS Total
Complaints resolution Panel 0 2 0 0 0 2 1 0 5
Australia Border Force / Customs 48 819 136 604 326 1,178 289 69 3,469
External Agencies, Other Regulatory Body, State Health Body 2 17 0 16 1 8 4 0 48
General public 1 81 1 46 8 41 19 0 197
Sponsor/client, Patient /Practitioner 2 32 1 9 2 15 6 0 67
TGA internal 1 30 1 18 4 7 4 2 67
Total 54 981 139 693 341 1,251 323 71 3,853

15. Pharmacovigilance Inspection Program

27 September 2018
Table 73 PVIP inspections undertaken and deficiencies identified
  2017-18
July to June[a]
Total completed 5
Total with completed findings 4
Critical deficiencies[b] 0
Major deficiencies[c] 21
Minor deficiencies[d] 10
Average deficiencies per inspection

5 major

3 minor


Footnotes


Version history

27 September 2018
Version history
Version Description of change Author Effective date
V1.0 Original publication Reporting and Collaboration Services 27/09/2018