Transcript No Slide Title

Total number of procedures finalised*
1995 to 1999
136
140
120
103
100
80
NAS
69
57
60
40
36
32
40
34
37
42
35
Others
Generics, OTC,
etc
19
20
5 2
3
0
1995
1996
1997
1998
1999
* The number includes double or triple procedures (N. = 650)
EMEA-MRFG-25-1998/Rev. 4
1
TOTAL NUMBER OF FINALISED PROCEDURES BY TYPE*
(1995 to 1999)
N.
%
Generics
186
28.7
Others
154
23.7
NAS
149
23.0
Line extension
79
12.1
Fixed Combination
58
9.0
OTC
15
2.3
Immunologicals
5
0.7
Herbal
3
0.4
Blood products
1
0.1
* The number includes double and triple procedures (N. = 650)
EMEA-MRFG-25-1998/Rev. 4
2
MUTUAL RECOGNITION
New active substances: STATUS OF THE PROCEDURES
(1995 1999)*
177 procedures*
8 pre-procedure phase
11 on-going
158 ended
149 finalised
3 arbitrations
6 withdrawn
* The number includes double and triple procedures
EMEA-MRFG-25-1998/Rev. 4
3
New Active Substances:
NUMBER OF PROCEDURES PER RMS
(1995 to 1999)*
29
DE
2
47
DK
2
4
ES
FI
FR
IT
29
1
35
22
6
IR
NL
SE
UK
* The number includes double and triple NAS procedures (N. =177)
EMEA-MRFG-25-1998/Rev. 4
4
Total number of finalised procedures by type in 1999
Generics
13
Blood products
35
Line extensions
91
5
OTC
Others
Immunologicals
New Active Substances
57
2
EMEA-MRFG-25-1998/Rev. 4
24
1
Fixed Combinations
5