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Half Yearly Performance Report Snapshot - July to December 2015

1 July - 31 December 2015

26 May 2016

Introduction

The TGA provides information on our regulatory performance to our stakeholders through the reports against the TGA key performance indicators and measures: Regulator Performance Framework. In addition to reporting against the Regulator Performance Framework, we will also publish our Key Performance Statistics, which provide detailed statistical information relating to the TGA’s performance. As the Regulator Performance Framework came into effect on 1 July 2015, the first report will be published after the close of the 2015-16 financial year.

The statistics provided in this half yearly performance snapshot cover the period 1 July to 31 December 2015. They provide an update on our progress for the past six months and will feed into the annual Key Performance Statistics report.

Performance highlights

Prescription medicines

  • The number of Category 11 and Category 32 submissions received remained relatively consistent with previous periods.
  • Mean processing times for Category 1 and 3 applications were well below the statutory timeframes of 255 days and 45 days respectively.

Over-the-Counter medicines

  • The number of new applications (N3 to N5) approved during July-December 2015 increased compared to January-June 2015, but was within the variability of previous periods over 2013-2015.
  • There was a large increase in the number of applications to make quality and non-quality related changes to existing medicines at the C1 application level. This is reflective of mandatory warning/cautionary labelling statements that were introduced during this period.
  • There was also an increase in the number of applications to make quality and non-quality related changes to existing medicines at the C2 application level. The number of applications to make changes at the C3 and C4 levels remained consistent with previous periods.
  • Mean processing times for all types of applications were below the agreed target timeframes. The percentage of applications completed within target timeframes was consistently higher than the 80% target.

Complementary medicines

  • The number of newly listed and registered complementary medicines entered on the ARTG is similar to the number of new entries reported in previous reporting periods.
  • There was a large increase in the number of new ingredients permitted for use in listed medicines. However, this was the result of TGA initiated assessments of 10 new ingredients.
  • The number of compliance reviews initiated increased significantly in the July-December 2015 period. This is largely the result of numerous business process improvement strategies that have been implemented to streamline the overall review process and improve review timeframes.
  • Medicines with verified compliance breaches were 72% for the July-December 2015 period, compared with 78% for July-December 2014 and 65.5% for January-June 2015. This is for a combination of both targeted and random reviews. This suggests that the overall rate of non-compliance has remained unchanged despite the significant increase in the number of compliance reviews.
  • A significant proportion of listed medicines reviews are concluded after the sponsor has adequately addressed the identified compliance breaches. This demonstrates that industry is willing to work with the TGA to ensure the supply of compliant medicines on the ARTG.

Medical devices

  • The transition periods for the up-classification of joint replacement implants and the new IVD regulatory framework both finished on 30 June 2015.  The end of these transition periods resulted in increased numbers of applications received in June 2015. Assessment of these additional applications has continued throughout the July to December 2015 period. Once these applications have been assessed it is expected that ongoing applications for these kinds of devices (joint replacements and IVDs) will settle to a more sustainable ongoing trend.

Medicine and vaccine adverse event reports

  • Several workshops have been provided to the pharmaceutical industry this year - in conjunction with ARCS Australia - on effective risk minimisation activities to improve the quality of the Risk Management Plans (RMPs).
  • We have obtained access to datasets from the Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) to assist with post-market monitoring. The first data linkage exercise with MBS and PBS data has been completed and is currently being analysed.

Regulatory compliance

  • There was a significant increase in the number of goods released to importers under the Personal Importation Scheme in the July-December 2015 period compared to previous periods. On the release of these goods, information was provided regarding obligations of importers utilising the Personal Importation Scheme to assist in future compliance.
  • Challenges that impacted on performance for this period included an increase in the number of alleged offences reported and significant staff turnover.

Scientific evaluation

  • The biologicals regulatory framework commenced in 2011 to regulate human cell and tissue-based products.  For products that were supplied prior to commencement, a three year transition period was available to allow lodgement of applications to move to the new framework.  In November the transition of all the biologicals supplied by the domestic ‘not for profit’ tissue banks was completed.

Clinical trials

  • On 1 July 2015, a new online form was made available under the Clinical Trial Notifications (CTN) Scheme.  This is the first in a series of developments to improve and streamline the administrative processes for the scheme, and has been well received by stakeholders. Workshops have also been undertaken to educate and inform stakeholders, and work continues to improve system functionality for the new system.

Laboratories

  • During the period between July and December 2015, a total of 4.7 million doses of 43 different vaccine products were released in 260 shipments.

Licencing and Manufacturing

  • As at 31 December 2015, there were 255 companies holding 400 Australian manufacturing licences covering 445 sites; and 354 overseas companies holding 414 manufacturer certificates covering 440 manufacturing sites.

Recalls

  • Initial review of the 97.5% of the safety related recalls (i.e. Class I and II) actions for medical devices, medicines and biologicals managed during the reporting period was undertaken within the target timeframe of 2 working days from the date of notification. This is in comparison with 95.1% during January to June 2015 and 97.2% during July to December 2014.

Processing and approval times

Processing and approval times are defined as the number of working days from the acceptance of the application until formal notification of decision, unless otherwise specified. Under the Therapeutic Goods Regulations 1990, TGA working days exclude public holidays and weekends. These exclude time where the TGA was unable to progress the application until the sponsor provided additional information or payment of fees, unless otherwise specified.

1Category 1: submissions to register new prescription medicines, or to make significant variations to an existing prescription medicine

2Category 3: variations to existing medicines that do not need to be supported by clinical, non-clinical or bioequivalence data

1. Prescription medicines

Table 1: Prescription medicine application approval times for July to December 2015
      Approval time
Application type Submissions approved Legislated timeframe Mean Median Range
A: New chemical entity
Category 1 19 255 195 200 143-253
B: New fixed-dose combination
Category 1 3 255 150 144 138-168
C: Extension of indication
Category 1 24 255 184 187 127-226
D: New generic medicine
Category 1 46 255 164 158 108-251
E: Additional trade name
Category 1 35 255a 209 218 129-252
F: Major variation
Category 1 21 255 170 162 110-245
G: Minor variationb
Category 1 1 255 147 147 N/A
Category 3 57 45 21 19 11-40
H: Minor variationc
Category 1 2 255 179 179 146-212
Category 3 628 45 22 19 4-236
J: Changes to product information requiring the evaluation of data
Category 1 42 255 126 134 14-204

a. In July 2015, a new process with a new legislative timeframe was introduced for additional trade name submissions. During the reporting period relevant to this report, these applications were under the Category 1 framework and a legislated timeframe of 255 working days applied.

b. The type G minor variations differ from type H minor variations in that they result in a new ARTG entry.

c. The minor variations (type H) included in the table above refer to applications to change the formulation, composition or design specification or the container for the goods or any other attribute that results in the goods being separate and distinct. These applications are typically 'Category 3' changes, unless the supporting scientific package contains non-clinical or clinical data in which case the application is a 'Category 1' application.

Further information about how prescription medicines are regulated in Australia can be found on the TGA website.

Figure 1: Number of approved Category 1 submissions by type for July to December 2015

Prescription medicine submissions may include a number of applications submitted at the one time. The data presented below relates to submission as this best reflects the evaluation and decision-making processes.

Pie chart displaying number of approved Category 1 submissions by application type

2. Over-the-Counter medicines

Table 2: Over-the-Counter medicine application processing times for approved applications for July to December 2015

New medicine applications
  Total approved Target approval time Mean Median Range Percentage within target
N1 Lower risk 49 45 11 9 2-27 100
N2 downward pointing arrow 1 75 26 26 N/Aa 100
N3 16 150 86 93 31-123 100
N4 28 170 109 96 27-159 100
N5 Higher risk 8 210 112 54 43-279 88
Change applications
  Total approved Target approval time Mean Median Range Percentage within target
C1 Lower risk 367 20 10 9 0-47 95
C2 downward pointing arrow 149 64 15 9 0-64 100
C3 4 120 40 33 20-76 100
C4 Higher risk 10 170 106 117 89-117 100

a. N/A: Not applicable – There was only one application of this type approved in this period.

Further information about how OTC medicines are regulated in Australia can be found on the TGA website.

3. Complementary medicines

3.1. Registered complementary medicines

Table 3: Number of approved registered complementary medicine applications
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
New registered medicines 3 1 2
Variation to registered medicines 15 13 14

Further information about how registered complementary medicines are regulated in Australia can be found on the TGA website.

3.2. Listed complementary medicines

Table 4: Number of new ingredients permitted for use in listed medicines
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
New permitted ingredients 4 1 14
Table 5: Number of new listed medicines
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
New listed medicines 1022 857 919
Table 6: Number of listed medicine reviews by type
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Reviews initiated
Targeted reviews 21 20 89
Random reviews 13 76 197
Total 34 96 286
Reviews completed
Targeted reviews 113 43 67
Random reviews 20 36 153
Total 133 79 220
Table 7: Number of completed listed medicine reviews by outcome
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Compliance status determined
Medicines with no compliance breaches 23 20 53
Medicines with verified compliance breaches 80 38 136
Sub-total 103 58 189
Compliance status unable to be determined
Medicines cancelled by sponsors after request for information 18 13 20
Medicines not yet manufactured 12 6 9
Other 0 2 1
Sub-total 30 21 30
Product not a therapeutic good 0 0 1
Total completed 133 79 220

Further information about how complementary medicines are regulated in Australia can be found on the TGA website.

4. Biologicals

Blood, blood components, plasma derivatives, tissue and cellular products, tissue and cell based derivatives, and other emerging biological therapies are regulated under the Therapeutic Goods Act 1989.

Table 8: Number of completed biological applications
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Technical Master File (TMF) new 0 1 0
TMF annual updates 2 2 2
TMF variations 6 0 4
TMF notifications 5 0 2
Plasma Master File annual updates 9 8 8
Biological Class 2 - new applications 9 3 4
Biological Class 3 - new applications 4 2 0
Biological Class 2 - variations 1 0 9
Biological Class 3 - variations 0 4 1
Total completed 36 20 30

Further information about how biological products are regulated in Australia can be found on the TGA website.

5. Medical Devices

Table 9: Number of completed applications and processing times for conformity assessments of medical devices (including in vitro diagnostic medical devices (IVDs)
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
New devices
Total completed 61 37 42
Percentage processed within target processing timeframes 100% 100% 100%
Mean TGA processing times 137 122 137
Median TGA processing times 195 151 178
Changes or recertification
Total completed 56 48 53
Percentage processed within target processing timeframes 100% 100% 100%
Mean TGA processing times 93 77 83
Median TGA processing time 79 48 57

The TGA is required to complete conformity assessment applications within 255 working days.

Table 10: Number of completed applications for inclusion of medical devices and IVDs in the ARTG
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Class I medical devices 1303 1194 1317
Class I measuring medical devices 30 44 19
Class I sterile medical devices 135 130 124
Class IIa medical devices 742 640 619
Class IIb medical devices 375 385 386
Class III medical devices 184 188 130
Class III Joint Reclassification medical devices 231 133 209
Active Implantable Medical Devices (AIMD) 42 4 7
Class 1 IVDs 72 86 71
Class 2 IVDs 104 123 94
Class 3 IVDs 74 109 107
Class 4 IVDs 15 40 20
Table 11: Number of application audits completed and processing times for medical devices and IVDs for July to December 2015
  Total completed Mean processing time Median processing time
Medical devices
Auto-included applicationsa 1317    
Applications completed without audit 1131b 8 6
Non-compulsory auditsc 246 47 28
Level 1 compulsory audits 10 7 0
Level 2 compulsory audits 107 154 140
IVDs
>Auto-included applicationsa 59    
Applications completed without audit 98b 6 4
IVD non-compulsory audit 10 57 56
IVD compulsory audit 125 41 40

a. Class I and Class 1 IVDs are automatically included medical devices and are not subject to audits before inclusion. Separate post-market monitoring is undertaken for these goods.

b. These figures do not include applications for Class I and Class 1 IVD auto-included devices. These applications are completed within 20 working days.

c. Non-compulsory audit – estimate for the audit processing time does not include applications for reclassification of join replacement medical devices received during transitional period (Class III Joint Reclassification medical devices), and applications supported by EC certificates issued by certain notified bodies (for details see increased application audit requirements for some medical device applications).

6. Exports

Table 12: Number of completed applications for export-only medicines and export certifications and relevant processing times for July to December 2015
  Total completed Target processing time Mean Median
Export-only medicines
New application 67 31 16 17
Variation 42 31 16 17
Export certificates
Medicine applications 1063 15 11.6 12
Medical device assessments 277 5 3.6 4

Completed applications include applications that were approved and withdrawn.

7. Access to unapproved therapeutic goods

7.1. Special Access Scheme

Table 13: Number of completed applications and notifications for the Special Access Scheme
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Medicines
Category A 18,698 19,162 20,688
Category B 10,557 11,211 9583
Medical devices
Category A 1968 1488 1960
Category B 1213 1060 993
Biologicals
Category A 38 77 22
Category B 1226 1217 1500

Further information about the Special Access Scheme can be found on the TGA website.

7.2 Authorised prescribers

Table 14     Number of authorised prescriber approvals for medicines and medical devices
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Medicines 324 356 297
Medical devices 129 144 121

Further information about authorised prescribers can be found on the TGA website.

7.3 Clinical trials

On 1 July 2015, a new online form was made available under the Clinical Trial Notifications (CTN) Scheme.  Table 15 and 16 provides data for new notifications received by the TGA regarding new clinical trials.

Table 15: Number of notifications for new clinical trials received by therapeutic good type for July to December 2015
Therapeutic good type Number
Medicine only 244
Medical devices only 65
Biologicals only 9
Medicine and medical device 132
Medical device and biological 5
Medicine and biological 9
Medicine, medical device and biological 5
Total 469

Due to changes in data collection and reporting, comparison to previous trend data is not available. This table does not include notifications of new sites for existing trials.

Table 16: Number of notifications for new clinical trials received by phases for July to December 2015
Clinical trial type Number
Phase 1 98
Phase 2 110
Phase 3 155
Phase 4 71
Bioavailability/equivalence 16
None specified 72

Due to changes in data collection and reporting, comparison to previous trend data is not available. It should be noted that a trial may be notified with more than one phase type.

Further information about clinical trials can be found on the TGA website.

8. Licencing and manufacturing

Number of manufacturing inspections by outcomea

Table 17A - Medicines and Blood, Tissue and Cellular Therapy
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 20152
Manufacturing licence applications (domestic manufacturers)
Number of inspections conducted 102 96 114
Satisfactory compliance 97% 89% 63%
Marginal compliance 3% 11% 18%
Unacceptable 0% 0% 1%
Close-out in progress - - 18%
Processing time
Initial inspections conducted within 3 months of application 88% 100% 59%
Re-inspections conducted within 6 months of due date 67% 64% 54%
Manufacturing certification applications (overseas manufacturers)
Number of inspections conducted 47 86 35
Satisfactory compliance 86% 94% 60%
Marginal compliance 11% 4% 3%
Unacceptable 3% 2% 3%
Close-out in progress - - 34%
Processing time
Initial certification inspections conducted within 6 months of application 90% 84% 25%
Certification re-inspections conducted within 6 months of due date 81% 80% 70%

a. Previous reports had excluded inspections that had been conducted during the reporting period but had not yet been closed out. To ensure we report on all activities conducted by the TGA the report for the current reporting period has been adjusted, but not previous reporting periods.

As at 31 December 2015, there were 255 companies holding 400 Australian manufacturing licences covering 445 sites; and 354 overseas companies holding 414 manufacturer certificates covering 440 manufacturing sites.

Table 17B - Devicesb
  Jul-Dec 2015
Manufacturing licence applications (domestic manufacturers)
Number of inspections conducted 21
Satisfactory compliance 47%
Marginal compliance 5%
Unacceptable 0%
Close-out in progress 48%
Processing time
Initial inspections conducted within 3 months of application 33%
Re-inspections conducted within 6 months of due date 22%
Manufacturing certification applications (overseas manufacturers)
Number of inspections conducted 9
Satisfactory compliance 11%
Marginal compliance 0%
Unacceptable 0%
Close-out in progress 89%
Processing time
Initial certification inspections conducted within 6 months of application 43%
Certification re-inspections conducted within 6 months of due date 0%

b. As medical devices and medicines are covered by different parts of the legislation, we have also begun reporting on the inspections conducted separately. Table 17A reports on inspections of Medicines and Blood, Tissue and Cellular Therapy product manufacturers while Table 17B reports on inspections of Medical Device manufacturers.

Applicants often submit applications for GMP licences and certifications and conformity assessment certificates before completing all of their systems and processes. The TGA works with the applicant to ensure an inspection is not conducted before the manufacturing facility is ready, as this may result in an adverse outcome. It is therefore not uncommon for initial inspections to be conducted later than the target of 3 and 6 months for licences and certifications respectively.

Table 18: Number of GMP clearance applications
Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Applications received 1,998 2,050 2,100
Renewal applications 684 1,141 887
Applications completed
Approved 1,897 2,550 2,819
Rejected 224 91 156
Total completed 2,121 2,641 2,975

GMP clearance is required for all medicines (unless exempt) supplied in Australia. This includes products supplied to sponsors by overseas manufacturers.

9. Recalls

Table 19: Number of therapeutic goods recalls
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Medicines 22 23 31
Medical devices (including IVDs) 291 286 291
Biologicals 0 0 0
Total recalls 313 309 322

10. Laboratories

Table 20: Number of samples tested by type of therapeutic good and percentage which failed for the period July to December 2015
Product type Total % fail
Prescription medicines 408 0.5%
OTC medicines 30 10%
Complementary medicines 54 16.7%
Medical devices 63 30.2%
Contracta 7 71.4%
Unregisteredb 165 84.2%

a. Performed on request for overseas regulators or aid agencies and encompasses medicines and medical devices.

b. Unregistered refers to products that meet the definition of therapeutic goods but are not included on the ARTG or otherwise specifically exempted from this requirement in the legislation.  This often includes adulterated complementary medicines or counterfeit products.

11. Medicine and Vaccine Adverse Event Reporting

Table 21: Source of notifications of medicine and vaccine adverse reaction
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Reports with clear causality, by reporter
Hospitals 1205 1197 1178
Companies 4202 4744 4566
General practitioners 340 405 272
Specialists 122 106 101
Pharmacists 594 638 469
Members of the public (consumers) 231 319 333
Nurses, dentists, complementary healthcare practitioners 113 111 91
State/Territory Health departments 1048 1512 1044
Reports withdrawn, or rejected, or without clear causality
797 973 443
Total received 8652 10,005 8497
Mean number of reports received weekly 332 385 326
Vaccine reports included in above table 1276 1983 1302

12. Medical device incident reports

Processing time is defined as the number of working days from the receipt of the notification until the incident has been investigated and resolved.

Table 22: Number of completed medical device incident reports and processing times
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Reports completed 2641 1499 1969
Mean TGA processing time 19 14 6
Percentage processed within target timeframe 86% 85% 93%
The target timeframe for processing of medical device incident reports is 90 working days.

13. Regulatory compliance

Table 23: Number of products investigated for compliance issues by product type
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Complementary medicines 260 226 216
Prescription medicines 383 477 648
Medical devices 81 75 46
Homoeopathic medicines 2 2 2
OTC medicines 32 54 17
Biological products 5 25 30
Other 14 17 31
Total 777 876 990
Table 24: Number of completed regulatory compliance investigations by final action taken
  Jul-Dec 2014 Jan-Jun 2015 Jul-Dec 2015
Warned 291 398 353
No offence detected 82 59 42
Goods released under Personal Import Scheme 29 45 119
Referred to another agency or department outside Health 5 4 6
Referred to another branch within the TGA 1 3 4
Import treated as abandoned goods by Customs 0 0 0
Recall of goods 0 0 0
Matters referred to the Commonwealth Director of Public Prosecutions 0 1 1
Total completed 408 510 525