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Annual performance statistics report: July 2016 to June 2017

12 September 2017

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11. Laboratory testing

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

The Laboratories Branch identifies and prioritises therapeutic goods for testing to fulfil the regulatory compliance and monitoring requirements of the TGA, and the transparency and accountability requirements of government. The testing program also provides flexibility and capacity to provide testing for investigations into problem reports, complaints and urgent public health concerns.

A risk management approach is used, which is consistent with ISO 31000: Risk Management principals and guidelines, to identify products with a higher risk of not complying with the required quality standards. This risk based, targeted approach to testing is reflected in the failure rates reported in the table below.

The Database of TGA Laboratory Testing Results was launched in the first half of 2017 to provide information to the public about the 2000-plus samples we test each year, and to increase understanding of how our testing program contributes to the regulation of therapeutic goods. Consumers and health professionals can now clearly see which products have been tested by the TGA, whether they passed or failed, and for those that did fail what regulatory action was taken. Providing this information has been an important enhancement to the transparency of the Government's regulatory processes and the vital role of the TGA in ensuring the quality, safety and efficacy of medicines and medical devices for Australian consumers.

Table 59 Samples and products tested by type of therapeutic good and percentage which failed
  2015-16 2016-17
July to June
Therapeutic good type
Prescription medicines Total 941 1,168
% fail 0.5 0.9
OTC medicines Total 47 51
% fail 19.1 13.7
Complementary medicines Total 108 87
% fail 20.4 13.8
Medical devices Total 114 168
% fail 29.8 31
Contracta Total 19 32
% fail 36.8 62.5
Unregisteredb Total 467 220
% fail 76.2 63.6
Total samples (excluding AHQ samples) 1,696 1,726
Total samplesc 2,202 2,328
Percentage fail 25.50% 14%
Total number of products testedd 761 590
  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 included 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 60 Samples that failed laboratory testing by reason for July 2016 to June 2017
  Medical devices OTC medicines Prescription medicines Unregistered products Complementary medicines Total
Reasons
Contamination 4 4 2 0 2 12
Formulation 0 0 4 136 6 146
Label and packaging deficiencies 8 2 0 0 0 10
Performance 23 1 4 0 3 31
Physical or mechanical properties 17 0 0 3 0 20
Unregistered 0 0 0 1 1 2
Total 52 7 10 140 12 221
Table 61 Batch release and export certification
  2015-16 2016-17
July to June
Batch releases and certifications
Batch releasea 401 453
Export certificationb 59 75
  1. Evaluation of batch release documentation for vaccines, biotechnology and blood products.
  2. Certification of biological products being exported from Australian manufacturers to overseas markets.

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 62 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 20 (95% of target times to be met) 40 (95% of target times to be met) 20 (95% of target times to be met)
Priority 40 (80% of target times to be met) 50 (80% of target times to be met) 40 (80% of target times to be met)
Routine 50 50 50

Testing on products linked to potential public safety concerns are assigned to the 'Urgent' testing category. Urgent testing may impact on the timeframes for priority and routing testing.

Priority is given to testing of products with the highest risk of a quality deficiency.

Compliance against these timeframes is outlined in the table below.

Table 63 Compliance with testing timeframes for July 2016 to June 2017
  Priority Total Percentage
Therapeutic good type
Medical devices Routine 128 90%
Priority 33 94%
Urgent 7 43%
OTC medicines Routine 34 56%
Priority 8 100%
Urgent 9 100%
Prescription medicines Routine 141 63%
Priority 9 78%
Urgent 6 83%
Complementary medicines Routine 56 66%
Priority 31 68%
Urgent 0 N/A
Unregistered products Routine 3 100%
Priority 213 95%
Urgent 4 100%

Low numbers of samples within categories may affect compliance percentages.

Samples involving complex biological assays are excluded from the target turnaround timeframes.

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