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Half-yearly performance reports - July to December 2014

31 March 2015

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3. Australian Register of Therapeutic Goods (ARTG)

3.1 New, variations and cancelled records

Table 80 Number of medicine registrations processed
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Prescription medicines
New medicine entries 958 814 1013 847 815
Changes (major and minor) 7554 7439 9979 9183 9070
Cancellations 86 332 77 305 87
OTC medicines
New medicine entries 140 159 89 177 198
Changes (major and minor) 182 129 176 178 132
Cancellations 13 146 9 107 30
Complementary medicines
New medicine entries 1 1 1 0 3
Changes (major and minor) 8 7 12 5 15
Cancellations 1 6 0 17 37
Table 81 Number of listings processed
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Medicines for supply in Australia
New medicine entries 875 872 954 970 1022
Changes (major and minor)* 783 784 853 604 596
Cancellations 382 958 207 1490 370
Medicines for export only
New medicine entries 155 81 76 54 63
Changes (major and minor) 40 74 22 52 39
Cancellations 143 98 19 98 17

*These figures have been revised from the previous report as there were calculation errors

Table 82 Number of medical device inclusions processed
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Included medical devices
New entries 2584 2863 3284 2961 2863
Cancellations 482 1752 639 2649 688
Included medical devices for export
New entries 115 95 170 198 366
Cancellations 20 32 42 37 12
Included IVD medical devices
New entries 233 228 267 283 220
Cancellations 8 6 8 8 11
Included IVD medical devices for export
New entries 4 4 5 1 0
Cancellations 1 2 0 0 0
other therapeutic goods
New entries 9 12 18 10 12
Cancellations 11 38 18 84 33
other therapeutic goods for export
New entries 0 0 0 0 0
Cancellations 0 0 0 0 0
Table 83 Number of biological inclusions processed
2013 2014
Jan-Jun Jul-Dec Jan-Jun Jul-Dec
New entries 1 1 0 13
Cancellations 0 0 0 0
Table 84 Cancellation of registered and listed devices
2012 2013 2014
Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec
Registered devices 0 0 0 0 0
Listed devices for supply in Australia 2 6 1 3 1
Listed devices for export only 0 0 0 0 0

3.2 ARTG product entries

Figure 15 Total number of product entries on the ARTG at end of reporting period
Figure 15 - Graph displaying the total number of product entries on the ARTG at end of each 6-monthly reporting period from 31 December 2012 to 31 December 2014.

Table 85 Number of medicine entries on the ARTG
2012 2013 2014
31 Dec 30 Jun 31 Dec 30 Jun 31 Dec
Medicine registrations
Prescription medicines 12,316 12,792 13,720 14,259 14,990
OTC medicines 3193 3096 3177 3249 3419
Complementary medicines 91 198 193 175 141
Total registered medicines 15,600 16,086 17,090 17,683 18,550
Medicine listings
Listed medicines 11,697 11,604 12,164 11,647 12,301
Export only medicines 2667 2650 2706 2662 2708
Total medicines 29,964 30,340 31,960 31,992 33,559
Table 86 Number of medical device entries on the ARTG
2012 2013 2014
31 Dec 30 Jun 31 Dec 30 Jun 31 Dec
Medical device inclusions
Included devices 39,478 40,574 42,917 43,219 45,400
Included IVDs 724 946 1205 1480 1689
Included devices for export only 722 778 906 1067 1421
Included IVDs for export only 12 14 19 23 23
other therapeutic goods
other therapeutic goods - listings and registrations 630 605 597 523 504
other therapeutic goods for export only 10 10 10 10 10
Total medical devices 41,576 42927 45654 46,322 49,047
Table 87 Number of biological entries on the ARTG
2013 2014
30 Jun 31 Dec 30 Jun 31 Dec
Biologicals 1 2 2 15
Table 88 ARTG totals
2012 2013 2014
31 Dec 30 Jun 31 Dec 30 Jun 31 Dec
Total registrations on the ARTG 71,540 73,289 77,617 78,316 82,621
Total number of sponsors 3443 3565 3639 3673 3833

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