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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.

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