Traduction de «applications and requests for amendments to existing » (Néerlandais → Français) :

The FAMHP’s Marketing authorisation Department is responsible for evaluating new applications and requests for amendments to existing marketing authorisation (MA) with a view to granting authorisation for marketing a medicine or health product.
The FAMHP’s Marketing authorisation Department is responsible for evaluating new applications and requests for amendments to existing marketing authorisation (MA) with a view to granting authorisation for marketing a medicine or health product.

In 2007, 560 new complete applications were submitted, 24% of which were for phase I trials, while 1214 amendments to existing or current applications were also submitted.
In 2007, 560 new complete applications were submitted, 24% of which were for phase I trials, while 1214 amendments to existing or current applications were also submitted.

In 2008, there was a significant increase observed in the number of applications for clinical trials and amendments (changes to an existing file) and of the percentage of phase I trials. The absolute number of non-commercial (“academic”) trials remained stable.
In 2008, there was a significant increase observed in the number of applications for clinical trials and amendments (changes to an existing file) and of the percentage of phase I trials. The absolute number of non-commercial (“academic”) trials remained stable.