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Annual performance statistics report: July 2016 to June 2017

12 September 2017

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12. Regulatory compliance

The TGA Regulatory Investigations and Enforcement Unit conducts compliance and enforcement activities against a risk based compliance framework. Using principles of responsive regulation, a range of tools are utilised including encouragement and guidance to comply, restrictions or warnings, suspensions or sanctions and cancellations. At the apex, activities including investigations into illegal import or manufacture of unapproved and counterfeit therapeutic goods can result in criminal or civil court action. All compliance activities have the intended purpose of protecting public health.

Table 64 Regulatory compliance investigations by final action taken
  2015-16 2016-17
July to June
Investigation in progress 361 1,136
Completed investigations
Warned (including destruction) 946 1,973
No offence detected 185 110
Goods released under Personal Import Scheme 519 691
Referred to another agency or department outside Health 28 21
Referred to another branch within the TGA 10 13
Filed for intelligence purposes 55 45
Finalised in a linked file 11 25
Import treated as abandoned goods by Customs 3 8
Recall of goods 2 1
Matters referred to the Commonwealth Director of Public Prosecutions 1 0
Total completed 1,760 2,887
Goods (units) seized and destroyed at the point of importationa N/A 884,081
  1. Due to a change in reporting function, the number of units can now be captured. Units refers to single dosage unit e.g. 1 tablet, 1 capsule, 1 tub of powder or single device.
Table 65 Types of products investigateda
  2015-16 2016-17
July to June
Therapeutic good type
Complementary medicines 463 599
Prescription medicines 1,802 4,367
Medical devices 98 166
Homoeopathic medicines 4 36
OTC medicines 45 54
Biological products 48 28
Other 66 119
Total 2,526 5,369
  1. Regulatory compliance investigations may include more than one type of product.
Table 66 Regulatory compliance investigations by special interest categories
  2015-16 2016-17
July to June
Compliance investigation category
Unapproved product 2,110 4,855
Counterfeit product 320 326
Parallel import/export 9 28
Manufacture without licence 1 8
Advertising offence 17 19
Traditional Chinese medicines 7 15
Othera 7 33
Total 2,471 5,284
  1. Products that fall outside the remit of the Therapeutic Goods Act 1989, for example food products.
Table 67 Investigations by complainant type and state/territory for July 2016 to June 2017
Origin ACT NSW NT QLD SA VIC WA TAS OtheraTotal
Complaints resolution 0 9 0 2 0 4 2 0 2 19
Customs 4 2,373 37 136 12 412 190 0 5 3,169
External agency 5 7 0 5 2 6 1 0 4 30
General public 4 13 0 5 0 17 3 0 136 178
Patient/ practitioner 0 1 0 1 1 2 0 0 2 7
Sponsor/client 2 9 0 2 1 6 2 0 16 38
TGA internal 51 1 0 0 0 0 0 0 0 52
Total 66 2413 37 151 16 447 198 0 165 3,493
  1. Other includes investigations of anonymous (unknown) origin.

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