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 |
---|
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 |
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 |
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%) |