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Half-yearly performance reports - July to December 2014

31 March 2015

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2. Postmarket activities

2.1 Licencing and manufacturing

2.1.1 Manufacturing licences

Table 47 Manufacturing licence applications
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
New licences granted 23 13 19 22 4
Withdrawn application 9 2 7 39 21
Revoked licences - Voluntary 0 0 19 23 6
Revoked licences - TGA 0 0 1 0 0
Ceased 16 29 0 0 0
Suspended 1 4 3 1 0
Suspended - Voluntary N/A N/A 3 1 0
Suspended - TGA N/A N/A 0 0 0

As at 31 December 2014, there were 414 Australian companies holding manufacturing licences covering 457 sites.

N/A=Not applicable. The separate recording of voluntary and TGA suspension of licences commenced in 2012–13.

Figure 12 Licence application outcomes for July to December 2014

Figure 12 - Pie graph displaying licence application outcomes for July to December 2014. 97% had Satisfactory compliance, 3% had Marginal compliance and 0% were Unacceptable

Table 48 Licence application outcomes
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
Inspections conducted 244 272 247 201 102
Satisfactory compliance 76% 81% 85% 89% 97%
Marginal compliance 23% 16% 12% 10% 3%
Unacceptable 1% 3% 3% 1% 0%
Initial inspections conducted within 3 months of application 81% 79% 60% 87% 56%
Re-inspections conducted within 6 months of due date 86% 68% 70% 64% 31%

Applicants often submit applications for Good Manufacturing Practice (GMP) licences before completing all of their systems and processes. It is therefore common for initial applications to be conducted later than the target of 3 months.

2.1.2 Manufacturing certifications

Table 49 Certification application status
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
New applications received 189 141 117 153 38
Re-inspection applications 235 172 229 172 83
Certified 119 130 156 133 67
Rejected 0 0 111 82 39

As at 31 December 2014, there were 410 overseas manufacturers covering 422 manufacturing sites.

Figure 13 Certification outcomes for July to December 2014

Figure 13 - Pie graph displaing certification outcomes for July to December 2014: 86%% had satisfactory compliance, 11%% marginal compliance and 3%% were unacceptable.

Table 50 Certification outcomes
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
Inspections conducted 157 143 109 113 47
Satisfactory compliance 84% 87% 86% 93% 86%
Marginal compliance 14% 13% 13% 7% 11%
Unacceptable 2% 0% 1% 0% 3%
Initial certifications inspections conducted within 6 months of application 90% 80% 74% 68%* 80%
Certification re-inspections conducted within 6 months of due date 75% 82% 68% 51% 44%

*Applicants often submit applications for GMP certification before completing all of their systems and processes. It is therefore common for initial applications to be conducted later than the target of 6 months.

2.1.3 GMP clearances

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

Table 51 Clearance application status
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
Applications received 2418 3900 3941 4222 1675
Renewal applications 1067 1172 1033 1218 730
Approved 3362 4103 3644 3539 1897
Rejected 18 232 92 73 224
Table 52 Clearance application outcomes
2010-11 2011-12 2012-13 2013-14 Jul-Dec 14
Evidence from a country with an MRA1 with Australia 1478 1444 1575 1500 621
Compliance Verification evidence2 520 283 316 299 130
TGA Certification 677 698 405 256 150
  1. MRA=Mutual Recognition Agreement between Australia and other countries, whereby the parties recognise and accept the certification issued by the relevant regulatory agency in each country in relation to manufacturers located within that country.
  2. Assessment of a recent GMP inspection report of the relevant overseas manufacturing site prepared by a competent overseas regulatory agency acceptable to the TGA, together with supporting manufacturing documentation supplied by the sponsor or manufacturer.

2.2 Laboratory testing

Table 53 Number of samples and products tested by TGA
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Prescription medicines Total 404 558 419 540 377
% fail 1% 2% 2% 1% 1%
OTC medicines Total 31 31 62 15 20
% fail 10% 13% 3% 0% 40%
Complementary medicines Total 54 71 42 200 77
% fail 24% 24% 24% 27% 30%
Medical devices Total 284 100 75 69 75
% fail 21% 23% 17% 30% 19%
Contract1 Total 12 3 2 47 23
% fail 25% 0% 0% 0% 22%
Unregistered2 Total 109 91 105 186 166
% fail 62% 67% 64% 82% 54%
Total samples per half year3 1000 938 816 1289 1013
Total samples per half year (excluding AHQ samples) 895 855 705 1057 738
Percentage fail per half year 17% 13% 14% 22% 19.6%
Total number of products tested per half year4 488 394 385 507 403
  1. Performed on request for overseas regulators or aid agencies and encompasses medicines and medical devices.
  2. Unregistered refers to products that meet the definition of therapeutic goods but are not on the ARTG or otherwise specifically exempted from this requirement in the legislation.  This often includes adulterated complementary medicines or counterfeit products.
  3. Includes accreditation, harmonisation and quality control (AHQ) samples.
  4. The TGA may test a number of samples of each product per reporting period.
Table 54 Laboratory testing: reason for failed samples, July to December 2014
Medical devices OTC medicines Prescription medicines Unregistered products Comp medicines Total
Contamination 5 0 1 3 1 10
Formulation 4 8 0 75 6 93
Label and packaging deficiencies 3 0 0 0 10 13
Performance 0 0 0 4 0 4
Physical or mechanical properties 2 0 4 8 6 20
Total 14 8 5 90 23 140
Table 55 Target timeframes for testing (working days)
Priority of testing Biochemical/chemical testing Microbiological testing Medical device testing
Urgent 20 (95% of target times to be met) 40 (95% of target times to be met) 20 (95% of target times to be met)
Priority 40 (80% of target times to be met) 50 (80% of target times to be met) 40 (80% of target times to be met)
Routine 50 50 50

Samples requiring biological testing are excluded from the target turnaround timeframes.

Table 56 Compliance with testing timeframes: July to December 2014
Priority Total Percentage
Medical devices Routine 122 78%
Priority 18 94%
Urgent 5 100%
OTC medicines Routine 26 65%
Priority 0 0%
Urgent 0 0%
Prescription medicines Routine 110 80%
Priority 21 100%
Urgent 0 0%
Complementary medicines Routine 91 69%
Priority 14 100%
Urgent 2 50%
Unregistered products Routine 67 69%
Priority 98 96%
Urgent 5 100%

Low numbers of samples in categories may affect compliance percentages.

Table 57 Batch release and export certification
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Batch release1 176 248 136 225 152
Export certification 26 75 23 36 5
  1. Vaccines, biotechnology and blood products: evaluation of batch release documentation.

2.3 Recalls

2.3.1 Medicine recalls

Table 58 Numbers of medicine recalls
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Recalls to consumer level 4 4 4 2 1
Recalls to hospital level 8 8 14 8 8
Recalls to retail level 9 5 5 7 10
Recalls to wholesale level 2 2 2 3 3
Total 23 19 25 20 22
Table 59 Medicine recalls: reason for recalls
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Adverse reactions 1 0 1 1 0
Foreign matter 0 1 1 0 3
Illegal supply 1 2 2 0 0
Impurity and degradation 0 1 0 3 3
Labelling and packaging 8 3 7 5 8
Micro-organisms 1 5 0 0 0
pH 0 0 0 0 0
Potency 0 1 1 1 1
Sterility 0 0 0 1 1
Other1 12 6 13 9 6
Total 23 19 25 20 22
  1. 'Other' includes dissolution, physical defects, observed differences, variable content, diagnostic inaccuracy and wrong product.

2.3.2  Medical device and biological recalls

Table 60 Medical devices (including IVDs): numbers of recalls
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Recalls to consumer level 8 11 11 11 4
Recalls to hospital level 246 265 280 262 270
Recalls to retail level 32 21 11 12 17
Recalls to wholesale level 2 3 3 2 0
Total medical device recalls 288 300 305 287 291
Table 61 Medical devices (including IVDs): reason for recalls
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Adverse incidents 2 1 1 0 1
Diagnostic inaccuracy 46 46 37 29 38
Electrical defect 22 20 10 17 25
Illegal supply 5 0 0 0 0
Labelling and packaging 53 49 56 61 43
Mechanical and physical defects 97 119 125 100 96
Software defects 47 55 65 69 59
Sterility 2 0 1 2 5
Other1 14 10 10 9 24
Total 288 300 305 287 291
  1. 'Other' includes bioavailability, disintegration/dissolution, microbial contamination, variable content, foreign matter, impurity, wrong product, therapeutic inefficiency and observed differences.
Table 62 Numbers of biologicals recalls
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Recalls to hospital level 0 7 0 2 0

2.4 Adverse medicine reaction reports

2.4.1 Incoming adverse medicine and vaccine reaction notifications

Figure 14 Total number of incoming adverse medicine reaction notifications received

Figure 14 - Graph displaying the total number of incoming adverse medicine reaction notifications received from July 2012 to December 2014

Table 63 Source of incoming notifications
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Hospitals 852 837 941 978 1205
Companies 4144 4499 5085 4183 4202
General Practitioners 349 372 357 397 340
Specialists 87 106 117 93 122
Pharmacists 552 562 717 630 594
Members of the Public (Consumer) 312 300 273 298 231
Nurses, dentists, complementary 90 99 76 117 113
State/Territory Health departments 757 1835 1276 1636 1048
General list (cause unclear) includes rejected and withdrawn 1121 1348 1256 952 797
Total 8264 9958 10098 9284 8652
Vaccine reports1 903 2125 1432 2008 1276
Average number of reports received weekly 317 383 388 357 332
  1. The data for vaccine reports comprise a subset of the total figure.

2.4.2 Communications and publications

Table 64 Communications and publications
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Requests for database output or other information 3388 4440 5570 6628 N/A1
1800 number calls received 286 312 204 1132 313
Public Contact Team (PCT)- Adverse reactions/events calls received N/A N/A 175 176 172
Medicines Safety Update (MSU) bulletin numbers 4, 5 ,6 7, 8, 9 10, 11, 12 13, 14, 15 16, 17, 18
  1. This figure is not reportable due to a change in email systems in this reporting period.
  2. This figure represents the calls about adverse events received to 1800 044 114 from Health professionals, consumers, manufacturers and sponsors. This service was taken over by AAPT from Telstra in late 2013 and due to the change-over the data for January to March 2014 was not recorded.
2.4.2.1 Medicines Safety Updates (MSU): July to December 2014

Medicines Safety Updates5 are medicines safety bulletins issued six times yearly by the TGA. Three editions were published during the current reporting period.

Early warning system: July to December 2014

The TGA's Early Warning System provides current and historical information on safety concerns for medicines and medical devices (also known as therapeutic products) that the TGA has identified through its therapeutic product vigilance program. Early warnings were issued on the following medicines between July to December 2014:

No Early warnings were issued for the period July to December 2014.

Medicine alerts: July to December 2014

Alerts provided by the TGA contain important information and recommendations about therapeutic products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. The following medicine alerts were published between July and December 2014:

  • Galantamine
  • Meningitec meningococcal serogroup C conjugate vaccine suspension for injection, single dose syringe
  • Children's Panadol 1-5 years Colourfree Suspension
  • Non-steroidal anti-inflammatory drugs and diclofenac reviews
  • Serotonin-blocking medicines used to treat nausea and vomiting
  • Propofol: Provive and Sandoz propofol 1% emulsion for injection - all sizes and all batches

2.5 Medical device incident reports

Table 65 Number of medical device incident reports received by financial year
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Total received 1861 2161 2346 3013 3051
User reports 537 480 492 898 458
Sponsor reports 1324 1681 1854 2115 2593
Table 66 Australian incident notification workflow
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Reports entered 1271 1255 1630 1498 1662
Reports completed 1148 1865 1443 1578 2641
Reports still in progress 970 687 627 498 169
Table 67 Australian incident notification: processing times
2012 2013 2014
Target Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Mean time to investigate and resolve 90 days 34 N/A 30 59 19
Percentage of reports not resolved in target time 0% 25% N/A 16% 18% 14%

N/A = not applicable. Data unavailable due to system recording failure.

Table 68 Device incident notification report outcomes
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Reviewed and used for trend analysis purposes 459 516 736 862 1801
Reviewed, no further action required 284 754 585 583 689
Product Recall 23 29 37 42 23
Recall for Product Correction 6 10 37 18 5
Hazard Alert 1 55 41 36 40
Product Notification 1 0 1 0 1
Safety Alert 5 4 11 46 11
Product Enhancement/Improvement Notice 1 2 1 1 1
Instructions for Use Amended 9 10 28 26 15
Referral for Post-Market Review 1 2 1 2 53
Referral to TGA Office of Manufacturing Quality 1 3 0 9 1
Refer to another TGA Office 13 26 28 35 28
Company warned 0 0 1 3 0
Product Suspended from ARTG 0 1 0 0 0
Product Cancelled from ARTG 3 26 5 1 1
Manufacturing Process Improvements 22 30 18 42 11
Quality System Process Improvements 3 1 6 5 8
Maintenance Carried out by the Hospital 0 1 1 1 0
Change to Design 12 26 8 6 11
Not Device Related 26 8 11 9 6
Other 20 43 44 97 119

2.6 Listed medicine reviews

Table 69 New and completed reviews
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
New reviews/investigations initiated
Targeted reviews 102 46 58 47 21
Random 2 4 19 22 13
Investigations1 22 42 7 49 38
Total 126 92 84 118 72
Reviews/investigations finalised
Targeted reviews 116 48 77 68 113
Random 27 14 6 21 20
Investigations1 38 22 23 32 46
Total 181 84 106 121 179
Reviews in progress as at last day of each 6 monthly period 190 200 271 178 86

All investigations are assessed and triaged based on a risk management approach. All investigations are actioned on this basis to provide the greatest overall benefit for the Australian public. Investigations may be finalised through a number of mechanisms, such as initiating a targeted review or referral to another area of the TGA.

  1. Investigations can include products not listed on the ARTG.
Table 70 Listing compliance review outcomes
Jul-Dec 2014
Number Percentage
No compliance breaches identified against selected listing requirements 23 17%
Medicines with verified compliance breaches against selected listing requirements 80 60%
Compliance status not determined
(Includes medicines cancelled after Section 31 notice issued, medicines not yet manufactured, financial cancellations etc.)
30 23%
Total 133 100%
Table 71 Listing compliance review issues
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Information provided in ARTG entry 6 4 3
Product: formulation/manufacturing/quality 4 8 6
Labelling and Advertising 40 49 34
Evidence 10 14 25
Other (e.g. Sponsor has failed to comply with a condition that the medicine is subject to; Sponsor has failed to comply with an additional condition of listing, etc.) 9 6 40

Individual listings may have multiple issues and actions.

Table 72 Actions taken for listed medicines
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Proposal to Cancel letter sent by the TGA 41 39 75
Medicines cancelled by TGA 7 6 45
Medicines cancelled by Sponsor after Proposal to Cancel letter issued 13 25 11
Medicines cancelled by Sponsor before compliance status could be determined e.g. after a section 31 notice was issued to Sponsor 6 18 18
Compliance reviews initiated but not able to be completed (e.g. medicine not yet manufactured or product cancelled for non - payment of fees) 9 10 13
Investigations resulting in initiation of target review 4 9 34

Individual listings may have multiple issues and actions.

2.7 Medical device postmarket reviews

Table 73 Devices verification: restricted word and targeted review workflow
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Restricted word reviews
Reviews completed 25 27 17 7
Reviews commenced 17 20 17 4
Reviews on hand 16 14 13 0
Targeted reviews
Reviews completed 101 63 114 94
Reviews commenced 41 83 136 33
Reviews on hand 151 320 413 67

2.8 Regulatory compliance

Table 74 Numbers of alleged offences
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Import 379 325 380
Supply 195 217 177
Manufacture 10 9 5
Claims 5 5 12
Export 2 2 2
Total 591 558 576
Table 75 Categorisation of final action taken
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Investigation in progress 222 257 168
Warned 223 371 291
No offence detected 90 100 82
Goods released under Personal Import Scheme 31 33 29
Referred to another agency or department outside of TGA 17 8 5
Referred to another Office within the TGA 7 8 1
Import treated as abandoned goods by Customs 1 0 0
Recall of goods 0 2 0
Matters referred to the Commonwealth Director of Public Prosecutions 0 3 0
Total 591 782 576
Table 76 Numbers of dosage forms investigated
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Capsule 279 236 172
Tablet 214 263 260
Topical 149 97 99
Medical device 124 97 82
Injection 65 87 78
Oral liquid 36 23 24
Drops 19 7 1
Spray 13 5 14
Powder 12 20 24
Oral jelly/paste 11 17 19
Inhalator 3 2 0
Lozenge 3 2 0
Transdermal 2 2 1
Oral food 1 2 1
Reagent Test Kit 1 0 0
Other 0 6 0
Total 932 866 775
Table 77 Types of products investigated
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Complementary medicines 390 421 260
Prescription medicines 349 318 383
Medical devices 121 100 81
Homoeopathic medicines 41 1 2
OTC medicines 17 9 32
Biological products 0 0 5
Other 17 18 14
Total 935 867 777
Table 78 Numbers of special interest investigations for each type
2013 2014
Jul-Dec Jan-Jun Jul-Dec
Unapproved product 770 678 677
Counterfeit 137 172 92
Parallel import/export 4 2 0
Manufacture without licence 2 1 0
Advertising offence 0 0 1
Traditional Chinese medicines 0 0 1
Other 5 6 2
Total 918 859 773
Table 79 Numbers of investigations by complainant type and state/territory
Origin ACT NSW NT QLD SA VIC WA Others Total
Complaints resolution 3 1 0 2 1 1 1 1 10
Customs 0 128 7 69 3 99 32 1 339
External agency 2 10 0 8 1 3 0 1 25
General public 0 15 0 4 4 4 2 100 129
Patient/practitioner 0 0 0 0 0 1 0 2 3
Sponsor/client 0 3 0 0 0 1 1 6 11
TGA internal 54 0 0 0 0 1 0 0 55
Total 59 157 7 83 9 110 36 111 572

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