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Description
Informations
Publié par | ansm-other-topics |
Publié le | 24 avril 2012 |
Nombre de lectures | 7 |
Licence : |
En savoir + Paternité, pas d'utilisation commerciale, pas de modification
|
Langue | English |
Extrait
Clinical trials for not health products
ACTIVITY STATEMENT
Clinical trials for not health products
Applications features
Number of clinical trial authorisation (CTA)
applications
Number of of applications for authorisation of
susbstantial amendments (SA)
Sponsors distribution:
Industry
Institutionnal
Area distribution (the 4 most important)
Physiopathology
Physiology
Therapeutic and preventive strategies
Diagnosis strategies
Afssaps assessment:
Number of CTA approved
Number of refusal
Number of withdrawal of applications
Number of SA approved
Assessment performance by Afssaps :
Mean time of CTA including recevability (days)
Mean time of MSA including recevability (days)
Afssaps- april 2012
2008
333
96
21%
79%
122
67
46
38
270
0
2
83
14
16,6
2009
598
259
11%
89%
264
125
104
61
547
0
6
250
12
12,8
2010
587
324
14%
86%
234
112
99
66
541
0
4
301
10
9,4
2011
768
392
14%
86%
166
273
135
100
641
0
6
358
10
8,9