Centralised authorisation procedure 2018

Updated 04 April 2019

The Danish share of assignments in the European pharmaceutical collaboration

The Danish Medicines Agency should have the greatest possible influence on decisions regarding new medicinal products and thereby the greatest possible influence on the future development of the European market for medicinal products.

Status for 2018 up to and including 4nd quarter

Denmark was assigned 18 human rapporteur/co-rapporteur cases and 5 veterinary rapporteur/co-rapporteur case, which is respectively 7 % and 10 % of all assigned central procedure cases in 2018.

Figure 1: Amount of assigned (co)rapporteurships in the EU in 2018 up to and including 4nd quarter

Number of assigned (co-)rapporteur cases in 2018, up to and incl. Q1

Figure 2. Share of human Rap/Co-rap cases

Share of human (co-)rapporteur cases in 2018, up to and incl. Q1

Table 1: Assigned human Rapporteur/co-rapporteur cases

Number of human procedures

2017

2018

Cases with DK as Rap/Co-rap

Total amount of cases

Cases with DK as Rap/Co-rap

Total amount of cases

1st quarter

2

37

2

55

2nd quarter

6

74

7

79

3rd quarter

3

48

4

54

4th quarter

2

42

5

59

Total

13

201

18

247

Figure 3. Share of veterinary Rap/Co-rap cases

Share of veterinary (co-)rapporteur cases in 2018, up to and incl. Q1

Table 2: Assigned veterinary Rapporteur cases/co-rapporteur cases

Number of veterinary procedures

2017

2018

Cases with DK as Rap/Co-rap

Total amount of cases

Cases with DK as Rap/Co-rap

Total amount of cases

1st quarter

1

19

0

8

2nd quarter

1

14

1

12

3rd quarter

1

7

0

8

4th quarter

1

4

4

24

Total

4

44

5

52