Exact(4)
Of all submitted dossiers from manufacturers to IQWiG until February 2014 , 23indirect comparisons could be identified.
A comparison between France and Germany is difficult, due to discrepancies between submitted dossiers regarding drug substance and applied indirect comparisons, which mostly differ in each country.
As shown in Tables 1 and 3, there are differences in the submitted comparisons as well as HTA-dossiers and available transparency (submitted dossiers, assessment by HTA-agency etc).
Unfortunately, in many cases, registrants submitted dossiers which show deficiencies and do not comply with the requirements of REACH or the Technical Guidance Document, e.g. necessary tests are missing [12, 13].
Similar(56)
But, he said, his foundation was encouraging foreign drug companies to submit dossiers to the agency.
ECHA submitted 55 dossiers, France 17, and Germany 32.
The REACH Regulation includes both the evaluation of submitted registration dossiers by ECHA and substance evaluations led by the individual EU member states.
From personal experience of some of the authors of this article with data submitted in dossiers of GM plants seeking regulatory approval, these substantial equivalence data do frequently yield significant differences even outside of reported ranges for other (at times 'historic') cultivars but are then dismissed as 'biologically irrelevant'.
The National Union of Journalists also submitted a dossier of 70 pieces of testimony.
submitted its dossier to the CMA, the regulator had 90 days in which to respond.
I submitted a dossier that included a corroborating note from the hospital and a picture of our day-old son.
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