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Annual performance statistics report: July 2018 to June 2019

21 October 2019

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12. Laboratory testing

The TGA conducts post-market monitoring and compliance testing, investigations and reviews, as well as market authorisation assessment of therapeutic goods.

We identify and prioritise therapeutic goods for testing to fulfil its regulatory compliance and monitoring requirements, 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.

Laboratory results are made available through the Database of TGA Laboratory Testing Results, 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.

Table 68 Samples and products tested by type of therapeutic good and percentage which failed
2017-18 2018-19
July to June
Therapeutic good type
Prescription medicines Total 1,106 1064
% fail 0.5 0.1
OTC medicines Total 59 20
% fail 6.8 0
Complementary medicines[a] Total 266 229
% fail 10.2 16.6
Medical devices Total 99 135
% fail 41.4 25.2
External[a] Total 70 29
% fail 8.6 13.8
Pacific Medicines Testing Program Total 21 57
% fail 14.3 21.1
Unregistered[b] Total 155 208
% fail 56.1 68.8
Total samples (excluding AHQ samples) 1776 1742
Total samples[c] 2005 2071
Percentage fail 10% 13%
Total number of products tested[d] 836 857

Footnotes


Table 69 Samples that failed laboratory testing by reason for July 2018 to June 2019
Medical devices OTC medicines Prescription medicines Unregistered products Complementary medicines External Pacific Medicines Testing Program Total (% fail)
Contamination 1 0 0 0 3 0 0 4 (0.2%)
Formulation 0 0 0 143 12 3 9 167 (10%)
Label and packaging deficiencies 21 0 0 0 21 0 0 42 (2%)
Performance 10 0 1 0 2 0 0 13 (0.7%)
Physical or mechanical properties 2 0 0 0 0 1 3 6 (0.3%)
Unregistered 0 0 0 0 0 0 0 0 (0.0%)
Total 34 0 1 143 38 4 12 232
Table 70 Batch release and export certification
2017-18 2018-19
July to June
Batch releases and certifications
Batch release[a] 432 385
Export certification[b] 34 33

Footnotes


Table 71 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 72 Compliance with testing timeframes for July 2018 to June 2019
Priority Number (% of Total)
Therapeutic good type
Medical devices Routine 82 (23%)
Priority 20 (20%)
Urgent 0
OTC medicines Routine 17 (88.2%)
Priority 3 (100.0%)
Urgent 0
Prescription medicines Routine 215 (62%)
Priority 14 (57%)
Urgent 22 (36%)
Complementary medicines Routine 206 (18%)
Priority 23 (35%)
Urgent 0
Unregistered products Routine 2 (0.1%)
Priority 195 (34%)
Urgent 11 (91%)

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