Clinical trials for medicines
3
pages
English
Documents
2012
Le téléchargement nécessite un accès à la bibliothèque YouScribe Tout savoir sur nos offres
3
pages
English
Documents
2012
Le téléchargement nécessite un accès à la bibliothèque YouScribe Tout savoir sur nos offres
Publié par
Publié le
24 avril 2012
Nombre de lectures
49
Langue
English
24/04/2012
Publié par
Publié le
24 avril 2012
Licence :
Langue
English
27,40%
39,80%
10,00%
31,63%
37,39%
10,11%
27%
16%
28%
18%
13%
6%
28%
18%
10%
7%
69%
31%
21,80%
31,70%
35,80%
9,70%
2011
914/871
1791
Oncology and hematology
Central nervous system
Infectious diseases
Cardiovascular diseases
Clinical trials for medicines (not including cell treatment or gene therapy)
ACTIVITY STATEMENT
Afssaps- april 2012
therapy)
Applications features
2008
1050/1000
960/920
941/903
10%
8%
2009
2010
1023
1440
Phase 1 :
Number of applications for authorisation of
susbstantial amendments (SA)
Industry
Institutionnal
Number of clinical trial authorisation (CTA)
applications /Number of clinical trials
1609
Phases distribution
74%
26%
73%
27%
Phase 2 :
Phase 3 :
Phase 4 :
Sponsors distribution
Therapeutic area distribution (the 4 most
important)
27%
16%
7%
10%
27,4%
37,1%
10,0%
21,90%
20,33%
74%
26%
24,8%
66 / 83 (80%)
7
1391
51844
5,9
48742
1095
20,6
39,9
/
42,1
15,8
41,3
37
40
1624
704
0
106 (12,2%)
72 (7,2%)
88 (9,5%)
790
0
67
959
753
0
43
1232
90 (10%)
723
1
42
1362
not including recevability (days)
including recevability (days)
Mean time of SA including recevability
(days)
Safety
20,9
/
41,9
/
12
Afssaps- april 2012
51380
Suspected unexpected serious adverse
reaction (SUSAR) reports
DSUR (Development Update Safety
Reports)
VHP (Voluntary Harmonisation Procedure
)
Number of clinical trials (including cell
treatment or gene therapy) involving
France/Number of clinical trials following
VHP (%)
Number of clinical trials with France as
Leading Member State
Mean time of national CTA including
recevability post CTFG (days)
* total notifications (initial + follow up; France+ foreigner)
861
21,3
1070
48562
Afssaps assessment
Number of CTA approved
Number of refusal
Number of withdrawal of applications
Number of SA approved
Clinical trials in children
Assessment performance by Afssaps
4,1
4,3
7
19/27 (70%)
Mean time of CTA :
Afssaps- april 2012
