Clinical trials for not health products - Activity Statement

Afssaps

Description

Other topics
24/04/2012

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

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Clinical trials for not health products
ACTIVITY STATEMENT
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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)
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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