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Number of submitted applications - IN

Traduction de «number of submitted applications - in » (Néerlandais → Français) :



For 2007, an analysis has been performed of the number of submitted applications versus the number of MA of medicines for human use granted.

For 2007, an analysis has been performed of the number of submitted applications versus the number of MA of medicines for human use granted.


It is also clear that the number of submitted applications continues to rise sharply compared with previous reference periods.

It is also clear that the number of submitted applications continues to rise sharply compared with previous reference periods.


Veterinary medicines Unit For the fifth year in a row the number of applications closed for obtaining marketing authorisation (MA) within the Veterinary medicines Unit has exceeded the number of new applications submitted.

Veterinary medicines Unit For the fifth year in a row the number of applications closed for obtaining marketing authorisation (MA) within the Veterinary medicines Unit has exceeded the number of new applications submitted.


Some achievements and figures for the Veterinary Medicines unit in 2007 KPIs and measurement results The most important KPI for this unit is the proportion of the number of finalised applications to the number of new, submitted applications, as a measure of the evolution of the unit’s backlog.

Some achievements and figures for the Veterinary Medicines unit in 2007 KPIs and measurement results The most important KPI for this unit is the proportion of the number of finalised applications to the number of new, submitted applications, as a measure of the evolution of the unit’s backlog.


Submitted applications Validated applications Applications in “Parking”system Finalised applications

Submitted applications Validated applications Applications in “Parking”system Finalised applications


One striking point is the clear trend towards an increasing number of phase I trials, from 17% in 2004 to 24% in 2007, as well as the increase in the number of submitted academic clinical trials: from 3% in 2004 to 7% in 2007.

One striking point is the clear trend towards an increasing number of phase I trials, from 17% in 2004 to 24% in 2007, as well as the increase in the number of submitted academic clinical trials: from 3% in 2004 to 7% in 2007.


Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

This release contains forward-looking information that involves substantial risks and uncertainties regarding Prevenar 13, including its potential benefits; and the success of the AMC project for vaccines. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matt ...[+++]


Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matters that could affect its availability or commercial potential; and competitive developments.

This release contains forward-looking information that involves substantial risks and uncertainties regarding Prevenar 13, including its potential benefits; and the success of the AMC project for vaccines. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities in countries where regulatory applications for Prevenar 13 may be pending or may be submitted will approve such applications and their decisions regarding labeling and other matt ...[+++]


U.S. Food and Drug Administration – Center for drug evaluation and research “Application number 21-395.

U.S. Food and Drug Administration – Center for drug evaluation and research”Application number 21-395.




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Date index: 2021-08-11
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