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AgVetLink: Number 60, February 2007
Review of Application Processes
In an Applications are showing a steady trend upwards following a low in early 2005 (see tables). The indications are activity will be strong in 2007.
The ‘ACVM Registration’ category in the tables represents the updating of product registrations to the ACVM Act. Following the transition of registrations there has been a large increase in some variations and administrative applications. In part, the administrative application increase was expected and reflects the renewal of registrations on a three-yearly cycle. It is probable increased awareness of registration requirements has led to more formulation/manufacturing and administrative variations being submitted.
There has been a large increase in new generic plant compound registrations in the last two years. In addition, there are more new product registrations including significant new actives and formulation types. The indications are that this trend is likely to extend into the near future.
Plant Compounds
Application Type |
2004 |
2005 |
2006 |
A1 - New active |
4 |
7 |
10 |
A2 - Known active |
8 |
7 |
13 |
ACVM Registration |
409 |
47 |
10 |
B1 - Identical |
19 |
3 |
5 |
B2 - Similar |
39 |
78 |
114 |
C1 - Formulation |
11 |
28 |
52 |
C2 - Manufacturing |
43 |
49 |
73 |
C3 - Shelf life |
27 |
28 |
37 |
C4 - Target host |
10 |
22 |
18 |
C5 - Pest/disease |
3 |
9 |
14 |
C6 - Dose/rate |
2 |
8 |
9 |
C7 – Admin method |
0 |
5 |
3 |
C8 - WHP |
1 |
1 |
0 |
C9 - Admin |
74 |
77 |
212 |
Provisional |
35 |
32 |
45 |
Research Approval |
7 |
11 |
4 |
Total |
692 |
412 |
619 |
Veterinary Medicines
Application Type |
2004 |
2005 |
2006 |
A1 - New active |
5 |
8 |
11 |
A2 - Known active |
6 |
7 |
16 |
ACVM Registration |
768 |
74 |
20 |
B1 - Identical |
5 |
5 |
12 |
B2 - Similar |
52 |
45 |
64 |
B3 – specified requirements |
50 |
24 |
29 |
C1 - Formulation |
13 |
53 |
51 |
C2 - Manufacturing |
129 |
165 |
218 |
C3 - Shelf life |
69 |
80 |
94 |
C4 - Target host |
4 |
2 |
3 |
C5 - Pest/disease |
9 |
6 |
11 |
C6 - Dose/rate |
5 |
7 |
4 |
C7 – Admin method |
2 |
2 |
3 |
C8 - WHP |
1 |
3 |
4 |
C9 - Admin |
90 |
161 |
412 |
Provisional |
11 |
12 |
18 |
Research Approval |
29 |
34 |
31 |
Total |
1248 |
688 |
1001 |
Vertebrate Toxic Agents
Application Type |
2004 |
2005 |
2006 |
A1 - New active |
0 |
3 |
0 |
A2 - Known active |
0 |
0 |
1 |
ACVM Registration |
22 |
18 |
3 |
B2 - Similar |
2 |
1 |
2 |
C1- Formulation |
0 |
0 |
4 |
C2 - Manufacturing |
4 |
1 |
6 |
C3 - Shelf life |
2 |
1 |
4 |
C4 - Target host |
0 |
0 |
1 |
C7 – Admin method |
0 |
1 |
1 |
C9 - Admin |
8 |
7 |
9 |
C10- Reassessment |
0 |
8 |
0 |
Provisional |
2 |
6 |
3 |
Total |
40 |
46 |
34 |
In an effort to reduce paperwork, time and costs, the Group is reviewing its application processes. Administrative changes and minor technical changes are likely to become simpler.
New Zealand Food Safety Authority
68-86 Jervois Quay
PO Box 2835
Wellington
NEW ZEALAND
Phone: +64 4 894 2500
Fax: +64 4 894 2501
Contact
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